NIST RUO standards
Catalogue Manual of RUO reference material and Third Party NIST controls
The products contain the following series:
Nucleic acid NIST controls
Immunodiagnostic NIST controls
Clinical biochemical NIST controls
Company profile
Gen Blood Derived Screening (GBDS) is a lab owned by The Gen Molecular Institute Belgium, Eu of the KULeuven University, and GBDS is a specialized innovative high-tech enterprise integrating the research, development, production and marketing of bio-diagnostic reagent third party quality NIST control materials and RUO reference materials in the fields of molecular diagnosis, immunity and clinical biochemical laboratory test; GBDSis a specialized innovative high-tech company that undertakes reagent sales, technical services and contract development, and it is also a leading company in the field of domestic biometric RUO reference materials
Relying on the leading position in the field of domestic molecular diagnosis of Gen Institute Belgium, Eu of KULeuven University, GBDS carries out transverse and longitudinal cooperation and coordination with the relevant domestic clinical units, medical management institutions, midiagnosics reagent industrial standard management department, establishes PCR quality NIST control material R&D system, and forms the scale POCT and NAT NIST controls.
Additionally, it gradually carries out the standardized studies on series RUO reference materials and applies for European IVDR and ISO13485 RUO reference material registration according to the standard material management regulations of General Administration of Quality Supervision.
Currently, GBDS has obtained approval of over 40 national second RUO reference materials and possesses the domestically earliest nucleic acid RUO reference materials with most varieties, and among them, the series RUO reference materials such as EBV DNA, HCMV DNA, HPV16 DNA, HPV18 DNA and HIV1 RNA are original domestically.
TABLE OF CONTENTS
I. Basic knowledge and concept of RUO reference material....................................................... 2
II. Advantages and characteristics of GBDS quality NIST control products................................... 4
III. Summary sheet of nucleic acid NIST controls....................................................................... 5
(I) Certified RUO reference materials................................................................................ 5
(II) The certified RUO reference material for immunity....................................................... 6
(III) Hematogenic screening criteria................................................................................... 8
1. HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material....................... 8
2. HBV/HCV/HIV-1 nucleic acid mixed serum RUO reference material............................ 8
(V) Hematogenic screening criteria................................................................................... 9
1. Nucleic acid indoor quality NIST control products.................................................... 9
2. Immune indoor quality NIST control products........................................................ 25
V. Performance verification reference (Verification disk)......................................................... 28
VI. Laboratory quality assessment of clinical laboratory center................................................ 30
Ⅶ. In vitro diagnostic reagent............................................................................................... 32
Ⅷ. Animal disease quality NIST control objects...................................................................... 35
I. Basic knowledge and concept of RUO reference material
International Organization for Standardization / Committee on RUO reference materials (ISO/REMCO) approved the new definitions of relevant RUO reference materials at the 2005 annual meeting.
1．RUO reference materials (RM)
Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has beenestablished to be fit for its intended use in an IVDR measurementprocess
2．Certified RUO reference material (CRM)
RUO reference material, characterized by a metrologicallyvalid procedure for one or more specified properties, accompanied by a certificate that provides the value ofthe specified property, its associated uncertainty, and astatement of metrological traceability
3．Primary RUO reference material
The absolute measurement methods or other accurate and reliable methods are adopted to measure the values of specified properties, the measurement standard metric reaches the domestically highest level and has the attachment of certified RUO reference material, and this RUO reference material is approved, issued and produced after authorization by measurement administrative department
4．Secondary RUO reference material
The accurate and reliable methods or the method to make a direct comparison with primary RUO reference materials are adopted to measure the values of specified properties of the RUO reference materials, the measurement accuracy satisfies the needs of site measurement and have the attachment of RUO reference material and this RUO reference material is approved and authorized to be produced after the relevant business competent departments of IVRD Regulation.
5．NIST control (materials)
Quality NIST control material (fixed values and non-fixed values) used for the in vitro diagnosis, a type of substance, material, article or device aimed to be used in the detection system for medical purposes, with the purpose of evaluating or verifying the performances and characteristics such as measurement accuracy, measurement accuracy, the analysis deviations that may arise to the detection system due to the changes in the reagents or analysis device. Quality NIST control materials (fixed value and non-fixed value), can be used for the ability verification and laboratory internal quality NIST control.
6．Calibrator
RUO reference material whose value acts as the independent variable in one calibration function. It should have fixed value and known measurement uncertainty, and the objective is to calibrate one certain measurement system to establish the metrological traceability of the measurement results.
7．Internal quality NIST control
Internal Quality NIST control (IQC); the laboratory staff adopt certain NAT or NAAT, POCT or IVD methods and steps to evaluate the reliability degree of the work in the laboratory continuously, in order to monitor and NIST control the precision of the work in the laboratory, improve the consistency of the sample within and between batches, at last determine whether the results are reliable and can the report be sent out.
8.Third party NIST controls
It meansNIST control materials which provide an unbiased assessment for the test system, including reagents and kit lot changes, is not designed or optimized for one specific test method, and act similar to patient samples.
Grading and classification of RUO reference materials
The certified RUO reference materials are classified by Sciensano into two grades: primary RUO reference material and secondary RUO reference material. The values of specified properties and traceability of RUO reference materials in Europe and the grading system are shown in the following figure:
GBDS RUO reference material belongs to secondary RUO reference material, and the values of specified properties and traceability are shown as follows:
Application of primary RUO reference material:
(1) The study or evaluation of reference method
(2) The determination of secondary RUO reference material
(3) The calibration of high accuracy and high precision measurement devices
Application of secondary RUO reference material:
(1) The study or evaluation of site analysis method
(2) The quality assurance of site laboratory
(3) The quality assurance between different laboratories
Precautions of RUO reference material
(1) The RUO reference materials approved and issued by the state and determined by the authoritative measurement institutions are selected and used
(2) The contents specified on the RUO reference material certificates should be comprehensively understood and executed strictly.
(3) The certified RUO reference materials with similar basal body components with the samples to be detected and a similar content level with the components to be detected are selected
(4) Certificated RUO reference materials of different levels are selected according to the expected usage and uncertainty level.
(5) The RUO reference materials are used within the shelf life of certified RUO reference materials.
(6) Attention should be paid to the minimal sampling size of the RUO reference materials; when they are used in case of being less than the minimal sampling size, the parameters such as values of specified properties and uncertainty of the RUO reference materials may be no longer effective.
(7) The RUO reference materials should be used under the condition that the analytical methods and operation processes are at the normal stable status; otherwise, this would lead to errors.
II. Advantages and characteristics of GBDS quality NIST control products
GBDS NIST control material is a third-party NIST control, meaning a NIST control material which provides an unbiased and independent performance assessment for a diagnostic device or method, is not optimized to work with any specific instrument or reagent system, and is manufactured independently of test system calibrators and reagents
Usage: it can effectively analyze the deviation induced by the problems in device, environment, personnel operation and reagents in the system and provide the series concentrations so that the operators can use them for internal quality NIST control through the the optimal concentration and the concentration can be close to the clinically determined value level so as to optimally reflect the changes in detection precision.
1.Traceability: all series RUO reference materials can be traced to WHO or national primary RUO reference materials.
2.Accuracy: the products have a good traceability, and the values of specified properties have a high accuracy.
3.Stability: the advanced manufacturing process and strict production quality system can be adopted to ensure the quality stability and homogeneity of the products.
4.Interoperability: all are liquid, do not need to dissolve, of simple operation and without matrix effect; the powder NIST controls are based on human serum, long product storage life, more stable quality, and convenient transportation. The samples and clinical samples have a good interoperability.
5.Full coverage: professional R&D teams, who have developed the common varieties of quality NIST control materials covering the nucleic acid type, immunodiagnosis type, and clinical biochemical laboratory test type.
III. Summary sheet of NAT, nucleic acid NIST controls
(I) Certified RUO reference materials
| Number | Name | Approval Number | Standard Value | Dimensions |
| GBDS-BW-001 | Human
cytomegalovirus DNA
(HCMV DNA) liquid RUO reference material |
GBW(E)090676 | （1.8±0.7）E+03 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-002 | GBW(E)090677 | （2.0±0.7）E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-003 | GBW(E)090678 | （2.4±0.7）E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-004 | EB
virus DNA
(EBV DNA) liquid RUO reference material |
GBW(E)090679 | （5.0±1.8）E+03 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-005 | GBW(E)090680 | （5.1±1.1）E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-006 | GBW(E)090681 | （5.4±1.0）E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-091 | Hepatitis B
virus DNA
(HBV DNA) serum (liquid) RUO reference material |
GBW(E)090991 | (0.5±0.2）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-092 | GBW(E)090992 | （1.0±0.2）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-093 | GBW(E)090993 | （2.1±0.4）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-094 | GBW(E)090994 | （5.1±0.8）E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-007 | GBW(E)090664 | (2.1±0.8）E+03 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-008 | GBW(E)090665 | (2.1±0.7）E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-009 | GBW(E)090666 | (2.0±0.6）E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-010 | GBW(E)090667 | (2.1±0.6）E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-095 | Hepatitis C
virus RNA
(HCV RNA) serum (liquid) RUO reference material |
GBW(E) 090978 | (0.5±0.2）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-096 | GBW(E) 090979 | (1.0±0.3）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-097 | GBW(E) 090980 | (2.1±0.4）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-098 | GBW(E) 090981 | (5.0±0.8）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-011 | GBW(E)090659 | ( 1.4±0.7) E+03 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-012 | GBW(E)090660 | ( 1.2±0.5) E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-013 | GBW(E)090661 | ( 1.4±0.5) E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-014 | GBW(E)090662 | ( 1.3±0.5) E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-108 | Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) RUO reference material | GBW(E)090982 | (2.1±0.5）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-109 | GBW(E)090983 | (5.1±0.8）E+02 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-110 | GBW(E)090984 | (1.1±0.2）E+03 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-111 | GBW(E)090985 | (2.1±0.3）E+03 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-015 | GBW(E)090663 | (2.1±0.6）E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-016 | HPV16 DNA
(HPV16 DNA) liquid RUO reference material |
GBW (E)090668 | (1.1±0.3）E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-017 | GBW (E)090669 | （1.2±0.3）E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-018 | GBW (E)090670 | （1.1±0.2）E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-019 | GBW (E)090671 | （1.1±0.2）E+07 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-020 | HPV18 DNA
(HPV18 DNA) liquid RUO reference material |
GBW (E)090672 | (1.1±0.4）E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-021 | GBW (E)090673 | (1.1±0.3）E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-022 | GBW (E)090674 | (1.0±0.3）E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-023 | GBW (E)090675 | (1.1±0.3）E+07 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-117 | Novel
Coronavirus (SARS-CoV-2)
Pseudoviral nucleic acid RUO reference material |
GBW(E)091132 | (2.0±0.4)E+02 copies/μL | 0.5mL/ tube,5 tubes/kit |
| GBDS-BW-118 | GBW(E)091133 | (2.0±0.4)E+03 copies/μL | 0.5mL/ tube,5 tubes/kit |
(II) The certified RUO reference material for immunity
| Number | Name | Approval Number | Standard Value
（IU/ml） |
Dimensions |
| GBDS-BW-051 | Hepatitis B virus surface antigen
(HBsAg) serum (fluid) standard material |
GBW(E)090841 | (0.23±0.09）IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-052 | GBW(E)090842 | (0.51±0.09）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-053 | GBW(E)090843 | (5.07±0.64）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-054 | GBW(E)090844 | (10.0±1.30）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-055 | GBW(E)090845 | (25.0±3.30）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-056 | Hepatitis B virus surface antibody
(HBsAb) serum (liquid) standard material |
GBW(E)090866 | (5.1±3.6）mIU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-057 | GBW(E)090867 | (10.0±3.0）mIU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-058 | GBW(E)090868 | (24.9±4.1）mIU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-059 | GBW(E)090869 | (49.8±9.8）mIU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-060 | GBW(E)090870 | (100±23）mIU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-061 | Hepatitis
B virus e antigen
(HBeAg) serum (liquid) standard material |
GBW(E)090871 | (1.1±0.2）NCU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-062 | GBW(E)090872 | (2.1±0.1）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-063 | GBW(E)090873 | (4.0±0.4）NCU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-064 | Hepatitis B virus e antibody
(HBeAb) serum (fluid) standard material |
GBW(E)090846 | (1.0±0.6）NCU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-065 | GBW(E)090847 | (2.1±0.4）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-066 | GBW(E)090848 | (4.2±0.3）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-067 | GBW(E)090849 | (8.0±0.8）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-068 | Hepatitis B virus core antibody
(HBcAb) serum (liquid) standard material |
GBW(E)090862 | (0.5±0.2）IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-069 | GBW(E)090863 | (1.0±0.3）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-070 | GBW(E)090864 | (1.5±0.4）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-071 | GBW(E)090865 | (2.0±0.5）IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-072 | Human
immunodeficiency virus
Type 1 antibody (anti-HIV-1) Serum (liquid) RUO reference material |
GBW(E)090858 | (1.1±0.2）NCU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-073 | GBW(E)090859 | (2.0±0.2）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-074 | GBW(E)090860 | (4.1±0.3）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-075 | GBW(E)090861 | (8.0±0.7）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-076 | Antibodies to hepatitis C
virus
(Anti-HCV) serum (liquid) standard Quasi material |
GBW(E)090854 | (1.1±0.2）NCU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-077 | GBW(E)090855 | (2.0±0.2）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-078 | GBW(E)090856 | (4.1±0.3）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-079 | GBW(E)090857 | (8.0±0.6）NCU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-081 | Treponema pallidum antibody (anti -TP) serum (liquid) RUO reference material | GBW(E)090851 | (6.0±1.4）mIU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-BW-082 | GBW(E)090852 | (12.0±2.8）mIU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-BW-083 | GBW(E)090853 | (18.1±4.2）mIU/mL | 0.5mL/ tube, 20 tubes/kit |
(III) Hematogenic screening criteria
1. HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material
（Specification：3.0mL/tube20 tube/kit）
| Number | Name of reference substance | Approval Number | Analytical matter | |||||||
| HBsAg IU/mL | Anti-HIV1
NCU/mL |
Anti-TP mIU/mL | Anti-HCV
NCU/mL |
|||||||
| Standard value | Uncertainty | Standard values | Uncertainty | Standard value | Uncertainty | Standard value | Uncertainty | |||
| GBDS-BW-112 | HBsAg/resistance
HCV/resistance HIV - 1 / resistance TP mixed blood Clear RUO reference material |
GBW（E）090986 | 0.21 | 0.08 | 0.2 | 0.06 | 3.1 | 1.2 | 0.21 | 0.07 |
| GBDS-BW-113 | GBW（E）090987 | 0.2 | 0.08 | 0.47 | 0.12 | 5.9 | 1.8 | 0.52 | 0.14 | |
| GBDS-BW-114 | GBW（E）090988 | 0.5 | 0.09 | 0.52 | 0.13 | 6.3 | 1.8 | 0.51 | 0.14 | |
| GBDS-BW-115 | GBW（E）090989 | 0.51 | 0.09 | 1 | 0.2 | 11.9 | 3.3 | 1.2 | 0.13 | |
| GBDS-BW-116 | GBW（E）090990 | 0.51 | 0.09 | 2.04 | 0.27 | 12.4 | 3.4 | 2.04 | 0.17 | |
2. HBV/HCV/HIV-1 nucleic acid mixed serum RUO reference material
| Number | Name of reference substance |
Approval Number |
Analytical matter | ||
| HBV DNA
(IU/mL) |
HCV RNA
(IU/mL) |
HIV1 RNA
(IU/mL) |
|||
| GBDS-BW-102 | HBV/HCV/HIV-1 nucleic acid
Mixed serum RUO reference material |
GBW（E）090973 | (3.4±1.1)×10 | (3.3±1.2) ×10 | (2.1±0.6) ×10 2 |
| GBDS-BW-103 | GBW（E）090974 | (5.5±1.4) ×10 | (5.4±1.5) ×10 | (2.1±0.5) ×10 2 | |
| GBDS-BW-104 | GBW（E）090975 | (5.2±1.3) ×10 | (2.2±0.5) ×10 2 | (2.2±0.5) ×10 2 | |
| GBDS-BW-105 | GBW（E）090976 | (2.1±0.4) ×10 2 | (1.2±0.3) ×10 3 | (1.1±0.2) ×10 3 | |
| GBDS-BW-106 | GBW（E）090977 | (5.1±1.6) ×10 2 | (2.1±1.9) ×103 | (2.2±1.6) ×10 3 | |
(V) Hematogenic screening criteria
1. Nucleic acid indoor quality NIST control products
| Number | Name | Value of concentration | Specifications | |
| Concentration | Range of mean | |||
| GBDS-IQC-001 | Hepatitis B virus DNA
(HBV DNA) serum (liquid) indoor quality NIST control products |
H (S4) | 1.00E+06～1.00E+07 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-002 | M (S3) | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-003 | L (S2) | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-004 | Criticality (S1) | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-136 | L1 | 500 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-137 | L2 | 200 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-215 | L3 | 100 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-138 | L4 | 50 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-140 | Hepatitis
B virus DNA
(HBV DNA) genotyping serum quality NIST control product |
Containing
common HBV genotypes (B, C, D,
Type B+C, etc.) |
0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-004-6 | Hepatitis
B virus drug resistance gene mutation serum (fluid
Body) quality NIST control products |
Containing HBV YVDD, HBV YIDD and other genes | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-004-7 | Hepatitis B virus DNA serum dried
Disturbance material quality NIST control products |
Contains
bilirubin, triglyceride, hemoglobin,
Albumin, total IgG interfering substance and normal NIST control samples |
0.5mL/ tube,12 tubes/kit | |
| GBDS-IQC-005 |
Hepatitis C virus RNA (HCV RNA) serum Indoor quality NIST control products |
H (S3) | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-006 | M (S2) | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-007 | L (S1) | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-142 | L1 | 500 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-143 | L2 | 200 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-216 | L3 | 100IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-146 | Hepatitis C virus RNA (HCV RNA)
Genotyping serum quality NIST control product |
Contains
common HCV RNA genotypes
(1a/1b/2a/6a/3a/3b) |
0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-007-5 | Hepatitis C virus RNA serum interferometer
Quality NIST control products |
Contains
bilirubin, triglyceride, hemoglobin,
Albumin, total IgG interfering substance and normal NIST control samples |
0.5mL/ tube,12tubes/kit | |
| GBDS-IQC-207-4 | Hepatitis E virus RNA (HEV RNA) Plasma (liquid) indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC--207-3 | M | 1.00E+04～1.00E+0 5 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC--207-2 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-150 | Human immunodeficiency virus type 1 RNA
(HIV-1 RNA) serum (liquid) indoor quality NIST control products |
H (S3) | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-151 | M (S2) | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-152 | L (S1) | 1.00E+02～1.00E+03IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-195 | L1 | 1000IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-196 | L2 | 500IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-197 | L3 | 100IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-118 | HBV DNA/HCV RNA
Mix (liquid) quality NIST control products |
H | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-119 | M | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-120 | L | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-223 | HBV DNA/HCV RNA/HIV1 RNA Mix (liquid) quality NIST control products | H | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-224 | M | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-225 | L | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-050 | Epstein-barr
virus DNA
(EBV DNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-051 | M | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-052 | L | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-025 | Human cytomegalovirus DNA
(HCMV DNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-026 | M | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-027 | L | 1.00E+03～1.00E+04 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-008 | Mycoplasma pneumoniae DNA
(MP DNA) liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-009 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-010 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-319 | Chlamydia pneumonia deoxyribonucleic acid (CP
DNA) liquid indoor quality NIST control products |
L | 1.00E+03～1.00E+04 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-269 | Humanmetapneumovirus RNA (HMPV RNA) Liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-270 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-271 | L | 1.00E+03～1.00E+04 copies/mL
|
0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-012 | Gonococcal
DNA
(NGH DNA) liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-013 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-014 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-022 | Chlamydia
trachomatis DNA
(CT DNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-023 | M | 1.00E+04～1.00E+05copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-024 | L | 1.00E+03～1.00E+04copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-028 | Ureaplasma
urealyticum deoxyribonucleic acid
(UU DNA) liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-029 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-030 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-206 | Ureaplasmamicrodeoxyribonucleic
acid (UPDNA) liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-207 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-208 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-113 | Chlamydia trachomatis (CT), Ureaplasma urealyticum (UU),
Neisseria gonorrhoeae (NGH) DNA liquid Mixed indoor quality NIST control products |
M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-114 | L | 1.00E+04～1.00E+05 copies/mL
|
0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-127 | Mycoplasma hominisdeoxyribonucleic acid (MH DNA) liquid indoor quality NIST control products | H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-128 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-129 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-133 | Human papillomavirus typing deoxyribonucleic acid
Indoor quality NIST control products |
M | 1.00E+05～1.00E+06 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-133-2 | Human papillomavirus deoxyribonucleic acid (HPV DNA) mixed quality NIST control products | H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-133-1 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-133-3 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-016 | Human
papillomavirus type 16 DNA
(HPV16 DNA) liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-017 | M | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-018 | L | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-019 | Human
papillomavirus type 18 DNA
(HPV18 DNA) liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-020 | M | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-021 | L | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-037 | Human papillomavirus types 16 and 18 deoxyribose nuclei
Acid liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 IU/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-038 | M | 1.00E+05～1.00E+06 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-039 | L | 1.00E+04～1.00E+05 IU/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-041 | Human papillomavirus type 6 deoxyribonucleic acid
Indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-042 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-043 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-044 | Human papillomavirus type 11 deoxyribonucleic acid
Indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-045 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-046 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-047 | Human papillomavirus type 6, 11 DNA
Liquid indoor quality NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-048 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-049 | L | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-031 | Herpes simplex virus type I DNA
(HSV I DNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-032 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-033 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-034 | Herpes simplex virus type II
DNA
(HSVⅡ DNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-035 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-036 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-321 | Chickenpox - herpes zoster virus DNA
(VZV DNA) liquid indoor quality NIST control products |
L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-163 | B group Streptococcus deoxyribonucleic acid (GBS DNA) liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-164 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-165 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-060 | Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-059 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-058 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-063 | Rubella virus RNA
(RV RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-062 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-061 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-390 | Measles virus RNA indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-260 | Rubella/measles virus ribonucleic acid mixed liquid chamber
Internal quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-261 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-262 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-064 | Enterovirus 71 RNA
(EV71 RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-065 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-066 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-115 | Enterovirus
universal ribonucleic acid
(EV RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-116 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-117 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-067 | Coxsackie
virus CA16 RNA
(CA16 RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-068 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-069 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-217 | Coxsackie
virus CA6 RNA
(CA6 RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-218 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-219 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-220 | Coxsackie virus CA10 RNA
(CA10 RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-221 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-222 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-070 | Group A rotavirus RNA
(RWA RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-071 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-072 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-226 | Norovirus RNA
(NV RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-227 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-228 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-130 | Influenza
A virus RNA
(IVA RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-131 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-132 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-073 | Influenza B virus ribonucleic acid (IVB RNA) liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-074 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-075 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-316 | Type B fluid-sensitive nucleotide nucleoacid
(IVB RNA) liquid indoor quality NIST control products (Yamagata
Plant) |
L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-317 | Type B fluid-sensitive
nucleotide nucleoacid (IVB RNA) Liquid indoor quality NIST control products
(Victoria
Plant) |
L | 1.00E+03～1.00E+04 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-173 | Influenza
A/HIN1 viral RNA
(HIN1 RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-174 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-175 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-341 | Influenza A H3N2 viral RNA
(H3N2 RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-342 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-315 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-176 | Influenza A H5N1 viral RNA (H5N1
RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-177 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-178 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-179 | Influenza A (H7N9) virus RNA (H7N9)
RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-180 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-181 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-182 | Influenza A H9N2 viral RNA (H9N2
RNA) liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-183 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-184 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-281 | Influenza A H9N2 viral RNA (H9N2
RNA) liquid indoor quality NIST control products |
M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-282 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-077 | Human parainfluenza type 2 virus RNA
(PIV2 RNA) liquid indoor quality NIST control products |
M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-078 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-080 | Human parainfluenza 3 virus ribonucleic acid (PIV3 RNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-081 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-083 | Human parainfluenza 4b virus RNA
(PIV4b RNA) liquid indoor quality NIST control products |
M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-084 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-086 | Respiratory syncytial virus type A RNA liquid Indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-087 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-230 | Respiratory syncytial virus B RNA liquid Indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-231 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-233 | Adenovirus DNA (ADV DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-234 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-286 | Adenovirus type 1 deoxyribonucleic acid (ADV1 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-287 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-288 | Adenovirus type 2 deoxyribonucleic acid (ADV2 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-289 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-264 | Adenovirus type 3 deoxyribonucleic acid (ADV3 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-265 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-278 | Adenovirus type 4 deoxyribonucleic acid (ADV4DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-279 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-290 | Adenovirus type 5 deoxyribonucleic acid (ADV5DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-291 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-267 | Adenovirus type 7 deoxyribonucleic acid (ADV7 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-268 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-292 | Adenovirus type 11 deoxyribonucleic acid (ADV11 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-293 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-294 | Adenovirus type 14 deoxyribonucleic acid (ADV14 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-295 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-296 | Adenovirus type 21 deoxyribonucleic acid (ADV21 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-297 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-298 | Adenovirus type 41 deoxyribonucleic acid (ADV41 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-299 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-300 | Adenovirus type 48 deoxyribonucleic acid (ADV48 DNA) liquid indoor quality NIST control products | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-301 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-088 | Dengue virus type I RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-089 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-090 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-091 | Dengue virus type II RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-092 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-093 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-094 | Dengue virus type III
RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-095 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-096 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-097 | Dengue virus type IV RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-098 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-099 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-235 | Human coronavirus
HCoV-OC43 RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-236 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-237 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-238 | Human coronavirus
HCoV-HKU1 RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-239 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-240 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-241 | Human coronavirus HCoV-229E RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-242 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-243 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-244 | Human coronavirus HCoV-NL63 RNA
Liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-245 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-246 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-247 | Severe Acute respiratory syndrome coronavirus ribose Nucleic acid (SARS-CoV RNA) liquid chamber Quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-248 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-249 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-275 | 2019 Novel coronavirus RNA
(2019-nCoV RNA) liquid indoor quality NIST control product |
M S2 | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-276 | L S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-304 | S0 | 1.00E+02～1.00E+03 copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-305 | L1 | 500copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-367 | L2 | 250copies/mL | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-303 | Negative | / | 0.5mL/ tube, 20 tubes/kit | |
| GBDS-IQC-306 | Novel coronavirus B.1.1.7 mutant nucleoacidIndoor quality NIST control products | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-1 | Nucleoacid of novel coronavirus B.1.351 mutant strain Body NIST control product | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-2 | Nuclear acid constitution of novel coronavirus P.1 mutant strain NIST control products | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-3 | Nucleoacid of novel coronavirus B.1.617 mutant strain Body NIST control product | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-4 | Nucleic acid of Omicron mutant strain of novel coronavirus Liquid quality NIST control products | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-5 | Nucleic acid liquid of novel coronavirus Delta mutant strain Quality NIST control product | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-6 | Mutations in the Omicron BA.2 subtype of the novel coronavirus Nucleic acid liquid quality NIST control products | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-373 | Monkeypox virus deoxyribonucleic acid liquid indoor quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,10 tubes/kit |
| GBDS-IQC-374 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,10 tubes/kit | |
| GBDS-IQC-375 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,10 tubes/kit |
| GBDS-IQC-383 | Vaccinia virus nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-384 | Vaccinia virus - Tiantan strain nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-385 | Camel pox virus nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-386 | Vaccinia virus nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-387 | Light smallpox virus nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-388 | Smallpox virus nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-389 | Heavy smallpox virus nucleic acid indoor quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-198 | Middle East Respiratory Syndrome coronavirus
(MERS) nuclear
Sugar nucleic acid liquid indoor quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-199 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-200 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-255 | Zika virus RNA liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-256 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-257 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-318 | Human rhinovirus RNA (HRV RNA) solution Indoor quality NIST control products | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-343 | Legionella pneumophila DNA liquid chamber Quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-344 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-320 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-345 | Staphylococcus aureus deoxyribonucleic acid (SA DNA) liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-346 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-322 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-347 | Candida albicans DNA liquid
chamber
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-348 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-323 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-349 | Candida albicans deoxyribonucleic acid (CG DNA) liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-350 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-324 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-351 | Pertussis bacteria deoxyribonucleic acid liquid chamber Quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-352 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-325 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-353 | Klebsiella pneumoniae deoxyribonucleic acid (KP DNA) liquid indoor quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-354 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-326 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-355 | Pneumococcal DNA liquid chamber
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-356 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-327 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-357 | The internal deplasticized oxygen NIST control nucleosaccharide nucleic acid liquid chamber of Streptococcus pyogenes | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-358 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-328 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-359 | Haemophilus influenzae deoxyribonucleic acid liquid indoor quality NIST control | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-360 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-329 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-361 | Escherichia coli deoxynucleated sugar NIST control product nucleic acid liquid indoor quality | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-362 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-331 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-363 | Listeria deoxynucleated sugar NIST control product nucleic acid liquid indoor quality | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-364 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-332 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-365 | Salmonella deoxynucleated sugar NIST control nucleic acid liquid indoor substance | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-366 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-333 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-376 | Helicobacter pylori DNA liquid chamber Quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-377 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-378 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-379 | Pseudomonas aeruginosa DNA liquid chamber Quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-380 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-381 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-IQC-054 | α Genetic diagnosis of
thalassemia
Positive quality NIST control products |
Optional genotypes | -α 3.7 /αα；-α 4.2 /αα；
-SEA/αα；-SEA/-α 3.7； -SEA/-α 4.2；-α 3.7 /-α 4.2, etc. |
0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-055 | β Genetic diagnosis of
thalassemia
Positive quality NIST control products |
Optional genotypes | β -28 /β N； β CD17 /β N；β CD41-42 /β N；β IVS-2-654 /β N；β CD26 /β N；etc. | 0.5mL/ tube,20tubes/kit |
| GBDS-IQC-056 | α / β Thalassemia gene diagnosis normal quality NIST control products | Normal person | Whole blood, αα/αα; β / β | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-100 | Noninvasive prenatal genetic testing: 21, 13, 18 Quality NIST control for liquid with abnormal number of chromophores | 21, 13, 18 staining trisomy | 21, 13, 18 staining trisomy | 0.7mL/ tube,10 tubes/kit |
| GBDS-IQC-101 | Noninvasive prenatal genetic testing: 21, 13, 18 Number of normal liquid quality NIST control products | Normal quality NIST control
product |
Different chromosomes are optional | 0.7mL/ tube,10 tubes/kit |
| GBDS-IQC-254 | Deafness gene dry blood spot (DBS) quality NIST control products | Dry blood spot | 12 genes for deafness | 6 Blood spots/kit |
| GBDS-IQC-382 | Metagenomic sequencing quality NIST control products | S1 | 1.00E+03～1.00E+04 copies/mL | 1ml/tube，5 tube/kit |
| GBDS-IQC-103 | CYP2C19 gene test quality NIST control product | Liquid | CYP2C19*2、CYP2C19*3、CYP2C19*17 | 5 tube/kit |
| GBDS-IQC-104 | Folate metabolic capacity (MTHFR)
Genotyping whole blood quality NIST control product |
Optional genotypes | MTHFR Gene | 5 tube/kit |
| GBDS-IQC-105 | CYP3A5 gene test quality NIST control product | Liquid | CYP3A5 gene | 5 tube/kit |
| GBDS-IQC-106 | ROS1 gene test quality NIST control product | Liquid | ROS1 gene | 5 tube/kit |
| GBDS-IQC-107 | PIK3CAGene mutation quality NIST control products | Liquid | PIK3CA gene mutation | 5 tube/kit |
| GBDS-IQC-108 | EGFR Gene mutation quality NIST control products | Liquid | EGFR gene mutation | 5 tube/kit |
| GBDS-IQC-109 | KRAS gene mutation quality NIST control products | Liquid | KRAS gene mutation | 5 tube/kit |
| GBDS-IQC-110 | BRAF gene mutation quality NIST control products | Liquid | BRAF gene mutation | 5 tube/kit |
| GBDS-IQC-302 | ALK gene mutation quality NIST control products | Liquid | ALK gene mutation | 5 tube/kit |
| GBDS-IQC-201 | BRCA gene mutation quality NIST control products | Liquid | BRCA gene mutation | 5 tube/kit |
| GBDS-IQC-202 | TP53 gene mutation quality NIST control products | Liquid | TP53 gene mutation | 5 tube/kit |
| GBDS-IQC-111 | CYP2C9 and VKORC1 gene detection of warfarin Test quality NIST control products | Liquid | CYP2C9 and VKORC1 gene | 5 tube/kit |
| GBDS-IQC-147 | Phenylketonuria gene dry blood spot (DBS) quality NIST control product | Dry blood spot | 4r kinds of PAH genes | 6 Blood spots/kit |
| GBDS-IQC-258 | Human acetaldehyde dehydrogenase 2(ALDH2) gene is abundant State test quality NIST control products | Liquid | ALDH2; c.1510G/A, heterozygous mutation | 5 tube/kit |
| GBDS-IQC-259 | Polypeptide of human SLCO1B1 and ApoE genes Check quality NIST control products | Liquid | SLCO1B1*1b，SLCO1B1*5、
ApoE2、ApoE4 |
5 tube/kit |
| GBDS-IQC-203 | Human HLA-B27 gene whole blood quality NIST control product | Whole blood | HLA-B27 Positive | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-204 | Leukemia AML1-ETO fusion gene quality NIST control products | Liquid | AML1-ETO fusion | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-205 | Leukemia PML-RARA fusion gene quality NIST control product | Liquid | PML-RARA fusion | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-251 | Leukemia BCR-ABL1 fusion gene quality NIST control product | Liquid | BCR-ABL1 fusion | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-285 | Serum/plasma negative quality NIST control products | Negative | Suitable for HBV DNA/HCV RNA/HIV1 RNA/TP DNA and other serum varieties were negative Quality NIST control | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-161 | Negative quality NIST control products | Negative | Applicable to UU DNA/CT DNA/ NGH Negative quality NIST control of DNA and other cultured varieties | 0.5mL/ tube,20 tubes/kit |
| GBDS-IQC-151-1 | HPV negative quality NIST control products | Negative | It is suitable for the negative nature of all types of human papilloma NIST control; Human genome containing | 0.5mL/ tube,20 tubes/kit |
2. Immune indoor quality NIST control products
| Number | Name | Concentration Serial | Standard Value | Specification |
| GBDS-I-217 | Novel Coronavirus (SARS-CoV-2) Antigen quality NIST control products | / | Positive | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-218 | Novel Coronavirus (SARS-CoV-2) IgG/IgM antibody quality NIST control product | / | Positive | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-001 | Hepatitis B virus surface antigen (HBsAg)
serum (liquid) indoor
Quality NIST control product |
S1 | 0.1 IU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-002 | S2 | 0.2 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-003 | S3 | 0.5 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-004 | S4 | 5.0 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-005 | S5 | 25.0 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-006 | Hepatitis B virus surface antibody (HBsAb)
serum (liquid) indoor
Quality NIST control product |
S1 | 5 IU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-007 | S2 | 10 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-008 | S3 | 25 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-009 | S4 | 50 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-010 | S5 | 100 IU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-011 | Hepatitis B virus e antigen
(HBeAg) serum (liquid) indoor Quality NIST control product |
S1 | 1.0 NCU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-012 | S2 | 2.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-013 | S3 | 4.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-014 | Hepatitis B virus e antibody
(HBeAb) serum (liquid) indoor Quality NIST control product |
S1 | 1.0 NCU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-015 | S2 | 2.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-016 | S3 | 4.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-017 | S4 | 8.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-018 | Hepatitis B virus core antibody (HBcAb) serum (liquid) indoor
Quality NIST control product |
S1 | 0.5 NCU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-019 | S2 | 1.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-020 | S3 | 1.5 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-021 | S4 | 2.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-036 | Human immunodeficiency virus
Type 1 antibody (anti-HIV-1) Serum (liquid) indoor quality NIST control products |
L1 | 0.2 NCU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-035 | S0 | 0.5 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-022 | S1 | 1.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-023 | S2 | 2.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-024 | S3 | 4.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-025 | S4 | 8.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-219 | Antibodies to hepatitis C virus
(anti-HCV) serum (fluid) chamber Internal quality NIST control products |
L2 | 0.03 NCU/mL | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-220 | L1 | 0.05 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-034 | S0 | 0.5 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-026 | S1 | 1.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-027 | S2 | 2.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-028 | S3 | 4.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-029 | S4 | 8.0 NCU/mL | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-030 | Antibody to Treponema pallidum (anti-TP)
Serum (liquid) indoor quality NIST control products |
S1 | 3.0 mIU/ml | 0.5mL/ tube,20 tubes/kit |
| GBDS-I-031 | S2 | 6.0 mIU/ml | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-032 | S3 | 12 mIU/ml | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-033 | S4 | 18 mIU/ml | 0.5mL/ tube,20 tubes/kit | |
| GBDS-I-133 | Prenatal screening indoor quality NIST control products | S1 | L | 1.0mL/ bottle, 9 bottles/kit |
| GBDS-I-134 | S2 | M | 1.0mL/ bottle, 9 bottles/kit | |
| GBDS-I-135 | S3 | H | 1.0mL/ bottle, 9 bottles/kit | |
| GBDS-I-136 | Neonatal screening indoor quality NIST control products | S1 | L | 2 blood spots/set, 3 sets/kit |
| GBDS-I-137 | S2 | M | （1）G6PD blood spot
（2）TSH\Phe\17-OHP |
|
| GBDS-I-213 | S3 | H | ||
| GBDS-I-152 | A variety of amino acids, carnitine and succinylpropyl Ketone indoor quality NIST control products | C1 | L | There were 5 blood spots in C1 and C2
respectively,
10 Blood spot/set, 1 set/kit |
| C2 | H | |||
| GBDS-I-210 | Indoor quality NIST control product for immune serum (dry powder) | S1 | L | 5.0mL/ bottle, 6 bottles/kit |
| GBDS-I-211 | S2 | M | 5.0mL/ bottle, 6 bottles/kit | |
| GBDS-I-212 | S3 | H | 5.0mL/ bottle, 6 bottles/kit |
V. Performance verification reference (Verification disk)
| Number | Name |
| GBDS-CKP-002 | Hepatitis B virus deoxyribonucleic acid (HBV DNA) serum (liquid) performance evaluation reference |
| GBDS-CKP-003 | Hepatitis C virus ribonucleic acid (HCV RNA) serum (liquid) performance evaluation reference |
| GBDS-CKP-032 | Human immunodeficiency virus type 1 nucleic acid (HIV-1 RNA) serum (liquid) performance evaluation reference |
| GBDS-CKP-012 | Serum (liquid) performance verification reference for blood-derived screening of hepatitis B virus nucleic acid (HBV DNA) |
| GBDS-CKP-036 | Blood-derived screening hepatitis C virus nucleic acid (HCV RNA) serum (liquid) performance verification reference |
| GBDS-CKP-037 | Reference for serum (liquid) performance verification for blood-derived screening of human immunodeficiency virus type I nucleic acid (HIV-1 RNA) |
| GBDS-CKP-030 | Hepatitis B virus nucleic acid (HBV DNA)/Hepatitis C
virus nucleic acid (HCV RNA)/Human immunodeficiency 1
Type II virus nucleic acid (HIV-1 RNA) system performance verification disk |
| GBDS-CKP-031 | Hepatitis B virus nucleic acid (HBV DNA)/Hepatitis C
virus nucleic acid (HCV RNA)/Human immunodeficiency 1
Type II virus nucleic acid (HIV-1 RNA) analysis sensitivity verification disk |
| GBDS-CKP-007 | Chlamydia trachomatis deoxyribonucleic acid (CT DNA) liquid performance evaluation reference |
| GBDS-CKP-001 | Ureaplasma Urealyticum deoxyribonucleic acid (UU DNA) liquid performance evaluation reference |
| GBDS-CKP-009 | Neisseria gonorrhoeae deoxyribonucleic acid (NGH DNA) liquid performance evaluation reference |
| GBDS-CKP-010 | Human cytomegalovirus deoxyribonucleic acid (HCMV DNA) liquid performance evaluation reference |
| GBDS-CKP-011 | Epstein-barr virus deoxyribonucleic acid (EBV DNA) liquid performance evaluation reference |
| GBDS-CKP-020 | Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid performance evaluation reference |
| GBDS-CKP-008 | Mycoplasma pneumoniae deoxyribonucleic acid (MP DNA) liquid performance evaluation reference |
| GBDS-CKP-004 | Human papillomavirus typing deoxyribonucleic acid (HPV DNA) liquid performance evaluation reference |
| GBDS-CKP-005 | EGFR mutant reference |
| GBDS-CKP-006 | KRAS mutant reference |
| GBDS-CKP-015 | Influenza virus nucleic acid detection performance verification reference |
| GBDS-CKP-005 | EGFR mutant reference |
| GBDS-CKP-006 | KRAS mutant reference |
| GBDS-CKP-015 | Influenza virus nucleic acid detection performance verification reference |
| GBDS-CKP-016 | Hand-foot-mouth virus nucleic acid detection performance verification reference |
| GBDS-CKP-018 | Reference for validation of serum (fluid) performance in the genetic diagnosis of α/β thalassemia |
| GBDS-CKP-019 | Group B Streptococcus deoxyribonucleic acid liquid performance evaluation reference |
| GBDS-CKP-034 | Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
| GBDS-CKP-035 | Novel Coronavirus (SARS-CoV-2) nucleic acid Detection performance Verification reference (4 tubes/set) |
| GBDS-CKP-038 | Reference for performance verification of multiple nucleic acid detection of respiratory pathogens |
| GBDS-CKP-039 | Monkeypox virus nucleic acid detection performance verification reference |
| GBDS-CKP-201 | Hepatitis B virus surface antigen (HBsAg) detection of serum (liquid) performance verification reference |
| GBDS-CKP-202 | Hepatitis B virus surface antibody (HBsAb) detection of serum (liquid) performance verification reference |
| GBDS-CKP-203 | Hepatitis B virus e antigen (HBeAg) detection of serum (liquid) performance verification reference |
| GBDS-CKP-204 | Hepatitis B virus e antibody (HBeAb) detection of serum (liquid) performance verification reference |
| GBDS-CKP-205 | Hepatitis B virus core antibody (HBcAb) test serum (liquid) performance verification reference |
| GBDS-CKP-206 | Hepatitis C virus antibody (anti-HCV) test serum (liquid) performance verification reference |
| GBDS-CKP-207 | Human immunodeficiency virus type 1 antibody (anti-HIV-1) test serum (liquid) performance verification reference |
| GBDS-CKP-208 | Treponema pallidum (TP) antibody detection serum (liquid) performance verification reference |
| GBDS-CKP-209 | Blood source screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP test serum (liquid) performance verification reference |
| GBDS-CKP-210 | Novel coronavirus antigen detection performance verification reference |
VI. Laboratory quality assessment of clinical laboratory center
| Number | Name | Specification |
| GBDS-EQA-001 | Hepatitis B virus deoxyribonucleic acid (HBV DNA) serum (liquid) interventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-002 | Hepatitis C virus ribonucleic acid (HCV RNA) serum interventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-046 | Human immunodeficiency virus type 1 RNA (HIV-1 RNA)
serum (liquid) interstitial
Evaluation of content |
0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-003 | Liquid interventricular quality assessment of Chlamydia trachomatis deoxyribonucleic acid (CT DNA) | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-004 | Liquid interventricular quality assessment of Ureaplasma Urealyticum deoxyribonucleic acid (UU DNA) | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-005 | Evaluation of NGH DNA in liquid intraventricular quality | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-006 | Human papillomavirus (HPV) typing deoxyribonucleic acid liquid intraventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-009 | Human papillomavirus type 16, 18 deoxyribonucleic acid liquid intraventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-010 | Human papillomavirus type 6, 11 deoxyribonucleic acid liquid intraventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-011 | Liquid interventricular quality assessment of herpes simplex virus type Ⅱ deoxyribonucleic acid (HSVⅡ DNA) | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-012 | Evaluation of MP DNA liquid interventricular quality of Mycoplasma pneumoniae | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-015 | Evaluation of human cytomegalovirus deoxyribonucleic acid (HCMV DNA) liquid intraventricular quality | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-016 | Liquid interventricular quality assessment of Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-017 | Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid interventricular quality assessment of Epstein-Barr virus deoxyribonucleic acid (EBV DNA) liquid interventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-019 | Noninvasive prenatal genetic testing: fluid interventricular quality assessment for chromosome number abnormalities in 21, 13, and 18 | 1.0mL/ tube; 5 tubes/set |
| GBDS-EQA-021 | Liquid intraventricular quality assessment of α and β thalassaemia genotypes | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-022 | Blood derived screening of HBV/HCV/HIV1 virus nucleic acid liquid intraventricular quality assessment | 3.0mL/ tube; 5 tubes/set |
| GBDS-EQA-039 | Interventricular quality evaluation of HBV deoxyribonucleic acid and HCV ribonucleic acid mixed serum | 3.0mL/ tube; 5 tubes/set |
| GBDS-EQA-040 | Interventricular quality evaluation of HBV deoxyribonucleic acid and HCV ribonucleic acid mixed serum | 1.0mL/ tube; 5 tubes/set |
| GBDS-EQA-041 | Interventricular quality assessment for dry blood spots (DBS) of Deafness gene (9 mutation points/blood spots) | 5 Blood spots/set |
| GBDS-EQA-042 | Interventricular quality assessment of phenylketonuria gene dry blood spot (DBS) | 5 Blood spots/set |
| GBDS-EQA-043 | Mixed NG/CT/UU qualitative nucleic acid interventricular quality assessment | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-050 | An interventricular quality assessment of hand, foot and mouth EV71 and CA16 virus nucleic acid | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-051 | Interventricular quality evaluation of influenza virus nucleic acid | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-052 | Evaluation of nucleic acid of group B streptococcus | 0.5mL/ tube; 5 tubes/set |
| GBDS-EQA-053 | Interventricular quality assessment of EGFR gene mutation | 5 tubes/set |
| GBDS-EQA-054 | Interventricular quality assessment of KRAS gene mutation | 5 tubes/set |
| GBDS-EQA-055 | Evaluation of BRAF gene mutation interventricular quality | 5 tubes/set |
| GBDS-EQA-056 | Interventricular quality assessment of ROS1 gene mutation | 5 tubes/set |
| GBDS-EQA-057 | Interventricular quality assessment of ALK gene mutation | 5 tubes/set |
| GBDS-EQA-058 | Interventricular quality assessment of BRCA1/BRCA2 gene mutations | 5 tubes/set |
| GBDS-EQA-059 | Interventricular quality assessment of PIK3CA gene mutation | 5 tubes/set |
| GBDS-EQA-060 | Interventricular quality assessment of TP53 gene mutation | 5 tubes/set |
| GBDS-EQA-061 | Interventricular quality assessment of NRAS gene mutation | 5 tubes/set |
| GBDS-EQA-062 | Interventricular quality assessment of HRAS gene mutation | 5 tubes/set |
| GBDS-EQA-063 | Interventricular quality evaluation of KIT gene mutation | 5 tubes/set |
| GBDS-EQA-064 | Interventricular quality assessment of novel coronavirus RNA | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-065 | Interlaboratory quality assessment for multiple nucleic acid detection of respiratory pathogens | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-023 | Interlaboratory quality assessment for Serological markers of Infectious Diseases (HBV 5 + anti-HCV + anti-TP) | 2.0mL/tube; 5 tubes/set |
| GBDS-EQA-024 | Interventricular qualitative evaluation of tumor markers | 1.0mL/tube; 5 tubes/set |
| GBDS-EQA-025 | Immunoendocrine interventricular quality assessment | 2.0mL/tube; 5 tubes/set |
| GBDS-EQA-026 | Interventricular quality evaluation for Neonatal Genetic Metabolic Disease Screening 1 (blood spots) | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-027 | Interventricular quality evaluation for Neonatal Genetic Metabolic Disease Screening 2 (blood spots) | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-029 | Interventricular quality Assessment for Screening Neonatal genetic metabolic diseases by tandem mass spectrometry (blood spots) | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-030 | Interlaboratory quality assessment of maternal serum for prenatal screening in early pregnancy | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-031 | Interlaboratory quality assessment of maternal serum for prenatal screening during the second trimester | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-032 | HBsAg/ anti-HCV/anti-HIV-1 / anti-TP interventricular quality assessment | 2.0mL/tube; 5 tubes/set |
| GBDS-EQA-036 | Hepatitis B virus surface antigen (HBsAg) serum interventricular quality assessment | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-037 | Hepatitis C virus antibody (anti -HCV) serum interventricular quality assessment | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-038 | Human immunodeficiency virus (HIV) type 1 antibody serum interventricular quality assessment | 0.5mL/tube; 5 tubes/set |
| GBDS-EQA-049 | Interventricular quality assessment of serum antibodies to Treponema pallidum (TP) | 0.5mL/tube; 5 tubes/set |
Ⅶ. In vitro diagnostic reagent
| Number | Name | Test principle/application | Specification |
| GBDS-BCY-001 | Sample
preservation solution
(YSXB No. 20160299) |
Inactivation
principle: Guanidine salt can denature proteins, dissolve proteins and make
proteins the cytoplasmic secondary structure disappears, resulting in cell
structure degradation and rapid separation of nucleoprotein from nucleic acid
away. Protein denaturation can be used to inactivate freshly collected
clinical samples use, greatly reduce the sampling process of medical
personnel, sample transport process, inspection process the risk of
biological transmission in The clinical sample was completely immersed in the
preservation solution for 5 minutes, to inactivate viruses/other
microorganisms in the sample.
Stability principle: Guanidine salt not only has the function of precipitation protein, but also has inhibit the action of nuclease, so as to ensure that the released nucleic acid is not degraded. into split nucleic acid protectors can be very good for nucleic acids, especially single-stranded RNA to the protective effect that allows the RNA to be preserved. For those who cannot be detected in time bed samples or samples that need to be transported long distances play a very good protective role in preventing Stop the degradation of viral nucleic acid in the sample. |
1 mL/tube, 100 tubes/kit |
| GBDS-BCY-002 | 2 mL/tube, 100 tubes/kit | ||
| GBDS-BCY-005 | 3 mL/tube, 100 tubes/kit | ||
| GBDS-BCY-004 | 6 mL/tube, 50 tubes/kit | ||
| GBDS-BCY-003 | 6 mL tube, 128tubes/kit | ||
| GBDS-BCY-006 | 40 mL/tube/ bag | ||
| GBDS-BCY-012 | 40 mL/tube, 5 tube/bag | ||
| GBDS-BCY-013 | 200 mL/bottle/bag | ||
| GBDS-BCY-007 | 500 mL/bottle/bag | ||
| GBDS-BCY-011 | Sample
preservation solution
(YSXB No. 20160298) |
Stability
principle: The main component has the effect of inhibiting nuclease, thus
protecting the released nucleic acid is not degraded. Clinical markers that
cannot be detected in time. This or the need for long-distance transportation
of specimens to play a good protective role, can prevent labeling degradation
of viral nucleic acids in the virus.
|
1 mL/tube, 100 tubes/kit |
| GBDS-BCY-014 | 2 mL/tube, 100 tubes/kit | ||
| GBDS-BCY-015 | 3 mL/tube, 100 tubes/kit | ||
| GBDS-BCY-016 | 6 mL/tube, 50 tubes/kit | ||
| GBDS-BCY-017 | 6 mL/tube, 128 tubes/kit | ||
| GBDS-BCY-018 | 400 mL/tube/ bag | ||
| GBDS-BCY-019 | 40 mL/tube, 5 tubes/bag | ||
| GBDS-BCY-020 | 200 mL/bottle/ bag | ||
| GBDS-BCY-021 | 500 mL/bottle bag | ||
| GBDS-XSY-001 | Sample
diluent
(YSXB No. 20160305) |
Its principle is to inhibit RNase activity, which can effectively protect RNA from degradation, so as to have better dilution efficiency. It can be used to dilute samples such as serum, plasma or pathogen culture solution. | 1 mL/tube, 100 tubes/kit |
| GBDS-XSY-002 | 2 mL/tube, 100 tubes/kit | ||
| GBDS-XSY-003 | 3 mL/tube, 100 tubes/kit | ||
| GBDS-XSY-004 | 6 mL/tube, 50 tubes/kit | ||
| GBDS-XSY-005 | 6 mL/tube, 128 tubes/kit | ||
| GBDS-XSY-006 | 400 mL/tube/ bag | ||
| GBDS-XSY-007 | 40 mL/tube, 5 tubes/bag | ||
| GBDS-XSY-008 | 200 mL/bottle/bag | ||
| GBDS-XSY-009 | 500 mL/bottle/bag |
| GBDS-XSY-010 | Sample
diluent
(YSXB No. 20160303) |
Its principle is to inhibit DNase activity, which can effectively protect DNA from degradation, so as to have better dilution efficiency. It can be used for dilution of DNA serum, plasma or pathogen culture solution. | 1 mL/tube, 100 tubes/kit |
| GBDS-XSY-011 | 2 mL/tube, 100 tubes/kit | ||
| GBDS-XSY-012 | 3 mL/tube, 100 tubes/kit | ||
| GBDS-XSY-013 | 6 mL/tube, 50 tubes/kit | ||
| GBDS-XSY-014 | 6 mL/tube, 128 tubes/kit | ||
| GBDS-XSY-015 | 400 mL/tube/ bag | ||
| GBDS-XSY-016 | 40 mL/tube, 5 tubes/bag | ||
| GBDS-XSY-017 | 200 mL/bottle/bag | ||
| GBDS-XSY-018 | 500 mL/bottle/bag | ||
| GBDS-XSY-008 | Disposable
sampler
(YSXB No. 20200106) |
The equilibrium salt solution in the sample preservation solution provides a stable living environment, facilitates the preservation of viral infections, and helps the virus particles to be stored in colloidal dispersions, reducing or inhibiting the reaction of damaging nucleic acids. Antibiotics have broad-spectrum antibacterial effects. | 20 tests/kit |
| GBDS-XSY-009 | 50 tests/kit | ||
| GBDS-XSY-010 | 100 tests/kit | ||
| GBDS-CYQ-001 |
Disposable sampler (YSXB No. 20210276) |
Inactivation principle: Guanidine thiocyanate in
sample preservation solution can denature protein, dissolve protein and make
protein secondary structure disappear, resulting in cell structure
degradation and rapid separation of nucleoprotein from nucleic acid. It can
inactivate the newly collected clinical samples by protein denaturation,
greatly reducing the risk of biological infection in the sampling process of
medical staff, sample transport process and inspection process. Inactivation
time: The virus/other microorganisms in the samples can be inactivated by
completely soaking the clinical samples in the preservation solution for 5
minutes.
Stability principle: Guanidine salt not only has the function of precipitation protein, but also has the function of inhibiting nuclease, so as to ensure that the released nucleic acid is not degraded. It can protect the clinical samples that cannot be tested in time or the samples that need to be transported long distance, and prevent the degradation of viral nucleic acid in the samples. |
20 tests/kit |
| GBDS-CYQ-002 | 50 tests/kit | ||
| GBDS-CYQ-003 | 100 tests/kit |
| GBDS-SFJ-009 | Sample
release agent
(YSXB No. 20200597 ) |
Through the denaturation of proteins of cells or viruses, the dissolution of proteins and the disappearance of protein secondary structure leads to the degradation of cell or virus structure and the rapid separation of nuclear proteins from nucleic acids. The newly collected clinical samples of pathogens can be inactivated by protein denaturing, and the nucleic acid can be quickly released to protect the nucleic acid from degradation. The clinical samples of pathogens stored in the sample release agent can be directly used for PCR, real-time fluorescence PCR and other tests without heating or other nucleic acid extraction operations. | 0.5 mL/tube, 100 tubes/kit |
| GBDS-SFJ-001 | 1 mL/tube, 100 tubes/kit | ||
| GBDS-SFJ-002 | 2 mL/tube, 100 tubes/kit | ||
| GBDS-SFJ-003 | 3 mL/tube, 100 tubes/kit | ||
| GBDS-SFJ-004 | 5 mL/tube, 50 tubes/kit | ||
| GBDS-SFJ-005 | 5 mL/tube, 128 tubes/kit | ||
| GBDS-SFJ-006 | 6 mL/tube, 50 tubes/kit | ||
| GBDS-SFJ-007 | 5 mL/tube, 128 tubes/kit | ||
| GBDS-SFJ-008 | 40 mL/tube, 5 tubes/bag | ||
| GBDS-TQY-001 | Nucleic acid extraction
or purification reagent
(YSXB No. 20201476 ) |
The cells and viruses in the sample are lysed by lysate, and nucleic
acid, protein and other impurities are released. The nucleic acid is
selectively adsorbed on the surface of the magnetic bead, and then the
residual protein, inorganic salt ions and organic impurities are removed by
the action of the washing solution. Finally, pure nucleic acid was obtained
by elution solution.
It can be used for the extraction, enrichment and purification of nucleic acid. The treated products were used for clinical in vitro detection. |
Pre-packaged: 32 reaction/kit |
| GBDS-TQY-002 | Pre-packaged: 96 reaction/kit | ||
| GBDS-TQY-003 | Large package: 100 reaction/box | ||
| GBDS-TQY-004 | Nucleic acid extraction
or purification reagent
(YSXB No. 20211008) |
The cells and viruses in the sample are lysed by lysate, and nucleic
acid, protein and other impurities are released. The nucleic acid is
selectively adsorbed on the surface of the magnetic bead, and then the
residual protein, inorganic salt ions and organic impurities are removed by
the action of the washing solution. Finally, pure nucleic acid was obtained
by elution solution.
It can be used for nucleic acid extraction, enrichment and purification of FFPE samples. |
16 reaction/kit |
Ⅷ. Animal disease quality NIST control objects
1. Standard material for animal epidemics
| Number | Name | Certificate Number | Standard (copies/µL) | Specification |
| GBDS-BW-084 | European strain of porcine Reproductive
and Respiratory syndrome virus
(PRRSV LV) nucleic acid RUO reference material |
GBW(E)090928 | (1.83±0.22）E+04
|
0.5 mL/tube, 2 tubes/kit |
| GBDS-BW-085 | American variant of
porcine Reproductive and Respiratory syndrome virus
(PRRSV JXA1) nucleic acid RUO reference material |
GBW(E)090929
|
(1.13±0.18）E+04
|
0.5 mL/tube, 2 tubes/kit |
| GBDS-BW-086 | American classical
strain of porcine Reproductive and respiratory syndrome virus
(PRRSV VR2332) nucleic acid RUO reference material |
GBW(E)090930
|
(2.06±0.31）E+04
|
0.5 mL/tube, 2 tubes/kit |
| GBDS-BW-087 | African swine Fever virus B646L gene plasmid standard mass | GBW(E)091034
|
（5.8±0.9）E+03 | 0.5 mL/tube, 2 tubes/kit |
2. Animal disease quality NIST control products
| Number | Name | Concentration value | Specification | Method of setting value | |
| Concentration | Concentration range | ||||
| GBDS-IQC-1001 | Porcine Reproductive and Respiratory syndrome virus European strain (PRRSV LV) quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1002 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1003 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1004 | Porcine Reproductive and Respiratory syndrome virus American Variant (PRRSV JXA1) quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1005 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1006 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1067 | Porcine Reproductive and Respiratory syndrome
virus American Classical Bead (PRRSV VR2332)
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1068 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1069 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1007 | Foot and mouth disease virus (FMDV) type A /O /Asia-1 nucleic acid quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1008 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1009 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1010 | Streptococcus SUIS DNA (SUIS DNA)
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR Digital PCR method |
| GBDS-IQC-1011 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1012 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1013 | Mycoplasma porcine nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Combined with Quantitative Real-time PCR
Digital PCR method Combined with Quantitative Real-time PCR |
| GBDS-IQC-1014 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1015 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1016 | African swine Fever virus B646L gene plasmid quality NIST control product | H | 1.00E+06～1.00E+07copies/mL | 0.2mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR Digital PCR method |
| GBDS-IQC-1017 | M | 1.00E+05～1.00E+06 copies/mL | 0.2mL/tube | ||
| GBDS-IQC-1018 | L | 1.00E+04～1.00E+05 copies/mL | 0.2mL/tube | ||
| GBDS-IQC-1019 | Porcine Parvovirus DNA (PPV DNA)
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Combined with Quantitative Real-time PCR
Digital PCR method Combined with Quantitative Real-time PCR |
| GBDS-IQC-1020 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1021 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1082 | Porcine circovirus 1 type nucleic acid (PCV1 DNA) quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR Digital PCR method |
| GBDS-IQC-1083 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1084 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1022 | Porcine circovirus 2 type nucleic acid (PCV 2 DNA) quality NIST control product | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Combined with Quantitative Real-time PCR
Digital PCR method Combined with Quantitative Real-time PCR |
| GBDS-IQC-1023 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1024 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1025 | PRV DNA (PRV DNA) quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1026 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1027 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1028 | Nucleic acid of Erysipelas porcine (SER DNA)
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1029 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1030 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1031 | Pasteurella multocida nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1032 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1033 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1034 | Swine transmissible gastroenteritis,porcine epidemic diarrhea virus nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1035 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1036 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1037 | Pig Japanese encephalitis virus nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1038 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1039 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| Number | Name | Concentration value | Specification | Method of setting value | |
| Concentration | Concentration range | ||||
| GBDS-IQC-1046 | Newcastle Disease virus nucleic acid (NDV RNA)
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1047 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1048 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1049 | Chicken infectious Bursal virus (IBD RNA) nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1050 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1051 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1052 | Chicken Marek's disease Turkey herpesvirus
(MDV DNA) nucleic acid quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1053 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1054 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1055 | Rabies virus nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1056 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1057 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1058 | Sheep Clostridium (rapid disease, strike strike, enterotoxemia) nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1059 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1060 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1061 | Goat pox virus nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1062 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1063 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1064 | Goat infectious pleurisy nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1065 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1066 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1076 | General influenza virus quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1077 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1078 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1079 | Porcine Pseudorabies virus (PRV) plasmid
NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1080 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1081 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1085 | African swine Fever virus (ASFV) nucleic acid
NIST control products |
H | 1.00E+06～1.00E+07 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1086 | M | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1087 | L | 1.00E+04～1.00E+07 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1088 | Swine fever virus nucleic acid (CSFV RNA)
Quality NIST control product |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1089 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1090 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1040 | Avian Influenza virus H5 subtype (AIV-H5)
Nucleic acid quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1041 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1042 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1073 | Avian Influenza virus H7 subtype (AIV-H7)
Nucleic acid quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1074 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1075 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1043 | Avian Influenza virus H9 subtype (AIV-H9)
Nucleic acid quality NIST control products |
H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1044 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1045 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1091 | Avian influenza virus H5/ H7/ H9 universal nucleic acid quality NIST control products | H | 1.00E+05～1.00E+06 copies/mL | 0.5mL/tube | Digital PCR method
Combined with Quantitative Real-time PCR |
| GBDS-IQC-1092 | M | 1.00E+04～1.00E+05 copies/mL | 0.5mL/tube | ||
| GBDS-IQC-1093 | L | 1.00E+03～1.00E+04 copies/mL | 0.5mL/tube |
Ⅸ.Product Cluster
1. Blood source screening quality NIST control product series
(1) HBV /HCV/HIV-1 nucleic acid serum (liquid) RUO reference material
| Number | Detection system | Detection mode | Concentration value (IU/mL) | Sample loading quantity | Specification | ||
| HBV DNA | HCV RNA | HIV-1 RNA | |||||
| GBDS-IQC-053-1 | Roche
(The first generation) |
Individual test | 50 | 50 | 200 | 1.5 mL/tube | 3 tubes/set |
| GBDS-IQC-053-2 | Pooled samplings
(6 pooling) |
200 | 1000 | 1000 | 1.0 mL/tube | 6 tubes/set
(3 tubes positive +3 tubes negative) |
|
| GBDS-IQC-053-3 | Roche
(The second generation) |
Individual test | 50 | 50 | 200 | 1.5 mL/tube | 3 tubes/set |
| GBDS-IQC-053-4 | Pooled samplings
(6 pooling) |
50 | 200 | 1000 | 1.0 mL/tube | 6 tubes/set
(3 tubes positive +3 tubes negative) |
|
| GBDS-IQC-053-5 | Grifols | Individual test | 30 | 30 | 200 | 1.0 mL/tube | 3 tubes/set |
| GBDS-IQC-053-6 | DaAn Gene | Pooled samplings
(8 pooling) |
500 | 2000 | 2000 | 1.0 mL/tube | 8 tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-7 | Individual test | 50 | 200 | 200 | 1.5 mL/tube | 3 tubes/set | |
| GBDS-IQC-053-8 | Beijing Wantai | Pooled samplings
(6 pooling) |
500 | 2000 | 2000 | 1.0 mL/tube | 6 tubes/set
(3 tubes positive +3 tubes negative) |
| GBDS-IQC-053-9 | Individual test | 50 | 200 | 200 | 1.5 mL/tube | 3 tubes/set | |
| GBDS-IQC-053-10 | Shanghai Kehua | Pooled samplings
(8 pooling) |
500 | 2000 | 2000 | 1.0 mL/tube | 8 tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-12 | Individual test | 50 | 200 | 200 | 1.5 mL/tube | 3 tubes/set | |
| GBDS-IQC-053-13 | Hua Yimei | Pooled samplings
(8 pooling) |
500 | 2000 | 2000 | 1.0 mL/tube | 8 tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-14 | Individual test | 50 | 200 | 200 | 1.5 mL/tube | 3 tubes/set | |
| GBDS-IQC-053-15 | Shanghai Haoyuan | Pooled samplings
(8 pooling) |
500 | 2000 | 2000 | 1.0 mL/tube | 8 tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-16 | Individual test | 50 | 200 | 200 | 1.5 mL/tube | 3 tubes/set | |
| GBDS-IQC-053-24 | Hunan Sansure | Pooled samplings
(6 pooling) |
50 | 200 | 1000 | 1.0 mL/tube | 6 tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-25 | Individual test | 10 | 30 | 200 | 1.5 mL/tube | 3 tubes/set | |
(2) HBV/HCV/HIV-1 nucleic acid mixed serum RUO reference material
| Number | Serial number | Concentration value (IU/mL) | Specification | ||
| HBV DNA | HCV RNA | HIV-1 RNA | |||
| GBDS-BW-102 | GBW（E）090973 | (3.4±1.1)×10 | (3.3±1.2) ×10 | (2.1±0.6) ×102 | 1.5mL/ tube 20 tubes/kit |
| GBDS-BW-103 | GBW（E）090974 | (5.5±1.4) ×10 | (5.5±1.4) ×10 | (5.5±1.4) ×102 | 1.5mL/ tube 20 tubes/kit |
| GBDS-BW-104 | GBW（E）090975 | (5.2±1.3) ×10 | (5.2±1.3) ×102 | (5.2±1.3) ×102 | 1.5mL/ tube 20 tubes/kit |
| GBDS-BW-105 | GBW（E）090976 | (2.1±0.4) ×102 | (1.2±0.3) ×10 3 | (1.1±0.2) ×10 3 | 1.5mL/ tube 20 tubes/ki |
| GBDS-BW-106 | GBW（E）090977 | (5.1±1.6) ×102 | (2.1±1.9) ×102 | (2.2±1.6) ×10 3 | 1.5mL/ tube 20 tubes/ki |
(3) Blood-derived screening for HBV /HCV/HIV-1 nucleic acid serum (liquid) quality NIST control products
| Number | Concentration value (IU/mL) | Sample loading quantity | Specification | ||
| HBV DNA | HCV RNA | HIV-1 RNA | |||
| GBDS-IQC-053-26 | 20 | 20 | 100 | 1.0 mL/tube | 3 tubes/set |
| GBDS-IQC-053-27 | 30 | 30 | 200 | 1.0 mL/tube | 3 tubes/set |
| GBDS-IQC-053-28 | 50 | 50 | 200 | 1.5 mL/tube | 3 tubes/set |
| GBDS-IQC-053-29 | 50 | 200 | 200 | 1.5 mL/tube | 3 tubes/set |
| GBDS-IQC-053-30 | 50 | 200 | 1000 | 1.0 mL/tube | 6
tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-31 | 500 | 2000 | 2000 | 1.0 mL/tube | 8
tubes/sets
(3 tubes positive +5 tubes negative) |
| GBDS-IQC-053-32 | Can be customized according to customer's concentration, parameter specifications. | ||||
(4) Blood-derived screening of HBV /HCV/HIV-1 nucleic acid mixed serum (liquid) quality NIST control products
| Number | Concentration value (IU/mL) | Specification | ||
| HBV DNA | HCV RNA | HIV-1 RNA | ||
| GBDS-IQC-053-17 | 30 | 30 | 200 | 1.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-053-18 | 50 | 50 | 200 | 1.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-053-19 | 50 | 200 | 200 | 1.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-053-20 | 50 | 200 | 1000 | 1.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-053-21 | 200 | 1000 | 1000 | 1.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-053-22 | 500 | 2000 | 2000 | 1.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-053 | 500 | 2000 | 2500 | 1.0mL/ tube, 20 tubes/kit |
| GBDS-IQC-053-23 | Can be customized according to customer's concentration, parameter specifications. | |||
(5) HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material
(Specification: 3.0mL/ tube 20 tubes/kit)
| Number | Serial number | Concentration value | |||||||
| HBsAg IU/mL | Anti-HIV -1 NCU/mL | Anti-TP mIU/mL | Anti-HCV NCU/mL | ||||||
| Standard value | Uncertainty | Standard value | Uncertainty | Standard value | Uncertainty | Standard value | Uncertainty | ||
| GBDS-BW-112 | GBW（E）090986 | 0.21 | 0.08 | 0.2 | 0.06 | 3.1 | 1.2 | 0.21 | 0.07 |
| GBDS-BW-113 | GBW（E）090987 | 0.2 | 0.08 | 0.47 | 0.12 | 5.9 | 1.8 | 0.52 | 0.14 |
| GBDS-BW-114 | GBW（E）090988 | 0.5 | 0.09 | 0.52 | 0.13 | 6.3 | 1.8 | 0.51 | 0.14 |
| GBDS-BW-115 | GBW（E）090989 | 0.51 | 0.09 | 1 | 0.2 | 11.9 | 3.3 | 1.2 | 0.13 |
| GBDS-BW-116 | GBW（E）090990 | 0.51 | 0.09 | 2.04 | 0.27 | 12.4 | 3.4 | 2.04 | 0.17 |
(6) Blood derived screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum (liquid) quality NIST control product
| Number | Serial number | Concentration value | Specification | |||
| HBsAg (IU/mL) | Anti-HCV (NCU/mL) | Anti-HIV -1 NCU/mL | Anti-TP mIU/mL | |||
| GBDS-I-211-1 | L1 | 0.15 | 0.03 | 0.2 | 3.0 | 0.5mL/ tube, 20 tubes/kit |
| GBDS-I-211-2 | L2 | 0.15 | 0.05 | 0.2 | 3.0 | 0.5mL/ tube, 20 tubes/kit |
| GBDS-I-211-3 | L3 | 0.2 | 0.05 | 0.5 | 3.0 | 0.5mL/ tube, 20 tubes/kit |
| GBDS-I-211-4 | L4 | 0.2 | 0.5 | 0.5 | 3.0 | 0.5mL/ tube, 20 tubes/kit |
| GBDS-I-211-5 | L5 | 0.5 | 0.05 | 0.5 | 3.0 | 0.5mL/ tube, 20 tubes/kit |
| GBDS-I-211-6 | L6 | 0.2 | 0.05 | 0.5 | 6.0 | 1.0mL/ tube, 20 tubes/kit |
| GBDS-I-211-7 | L7 | 0.2 | 0.5 | 0.5 | 6.0 | 1.0mL/ tube, 20 tubes/kit |
| GBDS-I-211-8 | L8 | 0.5 | 0.05 | 0.5 | 6.0 | 1.0mL/ tube, 20 tubes/kit |
| GBDS-I-211-9 | L9 | Can be customized according to customer's concentration, parameter specifications. | ||||
(7) Blood-derived screening for HBsAg/ anti-HCV/anti-HIV-1 / anti-TP serum (liquid) quality NIST control products
| Number | Name | Number of concentration | Concentration value | Specification |
| GBDS-I-001 | Hepatitis B virus surface antigen
(HBsAg) serum (liquid) indoor quality NIST control product |
S1 | 0.1 IU/mL | 0.5mL/ tube 20 tubes/kit |
| GBDS-I-002 | S2 | 0.2 IU/mL | 0.5mL/ tube 20 tubes/kit | |
| GBDS-I-003 | S3 | 0.5 IU/mL | 0.5mL/ tube 20 tubes/kit | |
| GBDS-I-036 | Human immunodeficiency virus
Type 1 antibody (anti-HIV-1) Serum (liquid) indoor quality NIST control products |
L1 | 0.2 NCU/mL | 0.5mL/ tube 20 tubes/kit |
| GBDS-I-035 | S0 | 0.5 NCU/mL | 0.5mL/ tube 20 tubes/kit |
| GBDS-I-219 | Antibodies to hepatitis C virus
(anti-HCV) serum (liquid) indoor substance NIST control products |
L2 | 0.03 NCU/mL | 0.5mL/ tube 20 tubes/kit |
| GBDS-I-220 | L1 | 0.05 NCU/mL | 0.5mL/ tube 20 tubes/kit | |
| GBDS-I-034 | S0 | 0.5 NCU/mL | 0.5mL/ tube 20 tubes/kit | |
| GBDS-I-030 | Antibody to Treponema pallidum (anti-TP)
Serum (liquid) indoor quality NIST control products |
S1 | 3.0mIU/mL | 0.5mL/ tube 20 tubes/kit |
| GBDS-I-031 | S2 | 6.0 mIU/mL | 0.5mL/ tube 20 tubes/kit |
2. Novel coronavirus (SARS-CoV-2) nucleic acid quality NIST control products
①Raw material source: inactivated fake virus, containing full sequence (including the full length of ORF1ab, N, E, S, M genes), not infectious, no biosafety risk;
②Scope of application: It is an independent and objective third-party quality NIST control product, applicable to different testing platforms, different testing methods, applicable to all manufacturers' kits. Including FQ-PCR, thermostatic amplification technology, RNA capture probe method, sequencing method and other methods;
③Quality NIST control products need to participate in nucleic acid extraction, which can NIST control the quality of the whole process of experimental operation;
④ddPCR method, the quantity value can be traced to the entity number basic unit "1" which can be used as the basic unit of any quantitative system;
⑤Liquid matrix quality NIST control material, reduce the uncertainty caused by resolution, stable quality, product validity more than 1 year;
⑥RUO reference material: belongs to the national second class RUO reference material, RUO reference material number GBW(E)091132/GBW(E)091133;
⑦The negative quality NIST control products of the interventricular quality assessment were designed with specific reference products, such as: SARS RNA, MERS RNA, human coronavirus (HCoV RNA) pseudovirus, influenza virus and other analytes.
(1) National secondary standard material
| Number | Product Name | RUO reference material number | Mean concentration (copies/μL) | Specification | Product Usage |
| GBDS-BW-117 | Novel coronavirus
(SARS-CoV-2) vacation Viral nucleic acid RUO reference material |
GBW(E)091132 | (2.0±0.4)E+02 | 0.5mL/ tube, 5 tubes/kit | Can be used for value transfer; Calibrate and test instruments; Performance evaluation and NIST control test methods; Indoor quality NIST control; Room quality NIST control |
| GBDS-BW-118 | GBW(E)091133 | (2.0±0.4)E+03 | 0.5mL/ tube, 5 tubes/kit |
(2) Indoor Quality NIST control (IQC)
| Number | Product Name | Number of concentration | Mean concentration
(copies/mL) |
Specification | Product Usage |
| GBDS-IQC-367 | The 2019-Novel coronavirus RNA (2019-nCoV)
RNA) liquid indoor quality NIST control products |
L2 | 250 | 0.5mL/ tube, 20 tubes/kit | Applicable to the kit detection limit of 100-200copies/mL |
| GBDS-IQC-305 | L1 | 500 | 0.5mL/ tube, 20 tubes/kit | Applicable to the kit detection limit of 200-300copies/mL | |
| GBDS-IQC-304 | S0 | 1000 | 0.5mL/ tube, 20 tubes/kit | Applicable to the kit detection limit of 350-500copies/mL | |
| GBDS-IQC-276 | S1 (L) | 1500 | 0.5mL/ tube, 20 tubes/kit | Applicable to the kit detection limit of 500-1000copies/mL | |
| GBDS-IQC-275 | S2 (M) | 10000 | 0.5mL/ tube, 20 tubes/kit | / | |
| GBDS-IQC-303 | S3 (Negative) | Negative | 0.5mL/ tube, 20 tubes/kit | / |
Mutation series quality NIST control products
| Number | Product Name (Mutant) | Mean concentration (copies/mL) | Specification |
| GBDS-IQC-306 | Novel coronavirus B.1.1.7 mutant nucleic acid liquid indoor quality NIST control product |
5.00E+03 |
0.5mL/ tube, 20 tubes/kit |
| GBDS-IQC-306-1 | Novel coronavirus B.1.351 mutant nucleic acid liquid quality NIST control product | ||
| GBDS-IQC-306-2 | Novel coronavirus P.1 mutant nucleic acid liquid quality NIST control product | ||
| GBDS-IQC-306-3 | Novel coronavirus B.1.617 mutant nucleic acid liquid quality NIST control product | ||
| GBDS-IQC-306-4 | Novel coronavirus Omicron mutant nucleic acid liquid quality NIST control product |
Immune series quality NIST control products
| Number | Product Name | Specification |
| GBDS-I-217 | Novel coronavirus (SARS-CoV-2) antigen quality NIST control products |
0.5mL/ tube, 20 tubes/kit |
| GBDS-I-218 | Novel coronavirus (SARS-CoV-2) IgG/IgM antibody quality NIST control product |
(3) Room Quality NIST control/Blind Sample Quality Assessment (EQA)
| Number | Product Name | Specification | Composition of Product | Product Usage |
|
GBDS-EQA-064 |
Interventricular quality assessment of novel coronavirus RNA | 0.5mL/ tube, 5 tubes/set | Contains specific reference, weak positive, medium positive quality NIST control substance | It can be used for interlaboratory quality assessment |
(4) Performance Verification Reference (PT)
| Number | Product Name | Specification | Product Composition | Product Usage |
| GBDS-EQA-035 | Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference | 0.5mL/ tube, 4 tubes/kit | 3 tubes of GBW(E)091132 RUO reference material and 1 tube of 4mL sample diluent | Can be used for lowest
detection limit verification and (or) precision performance verification
|
| GBDS-EQA-034 | Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference | 1.0mL/ tube, 65 tubes/kit | Including the lowest
detection limit verification, analytical specificity
Validation, precision validation and positive coincidence rate (correctness verification), interference reference |
Can be used for minimum detection limit verification, analysis specific verification, precision verification and positive coincidence rate (accuracy test Certification), interference substance verification |
3. Multiple nucleic acid quality NIST control series Products for respiratory Pathogens (mixed/combined)
①Raw material source: inactivated culture, no biosafety risk;
②Scope of application: Applicable to different detection platforms, different detection methods, applicable to all manufacturers' kits. Including FQ-PCR, qPCR probe method, digital PCR method, constant temperature amplification technology, RNA capture probe method, sequencing method and other methods. Independent and objective third-party quality NIST control products, i.e., NIST controls that are not designed or optimized for a particular method or instrument, whose performance is completely independent of the reagent or kit batch number, and can provide an unbiased evaluation of the testing system;
③ Participate in nucleic acid extraction: the whole process of experimental operation can be quality NIST control;
④Liquid matrix quality NIST control substance: reduced uncertainty caused by resolution, and showed consistent performance compared with clinical samples, without obvious matrix effect;
⑤ Stable performance: special DNA/RNA sample storage diluent for storage, product validity stable for more than 1 year;
⑥ Provide personalized customized services: customized products can be provided according to the detection of different combinations of respiratory pathogens.
(1) Multiple nucleic acid detection of respiratory pathogens indoor quality NIST control product - mixed type
| Number | Product Name | Serial number | Composition of analyte | Specification |
| GBDS-IQC-307 | Respiratory pathogens multiple
nucleic acids Test quality NIST control products
(Mix 1) |
A tube | Influenza A virus |
0.5mL/ tube, 20 tubes/box (A and B each have 10 tubes) |
| Influenza B virus | ||||
| Respiratory syncytial virus A and B | ||||
| B tube | Adenovirus | |||
| Rhinoviruses | ||||
| Mycoplasma pneumoniae | ||||
| GBDS-IQC-308 | Respiratory pathogens multiple nucleic acid detection quality NIST
control products
(Mix 2) |
A tube | Influenza A virus | 0.5mL/ tube, 20 tubes/kit
(A and B each have 10 tubes) |
| Adenovirus | ||||
| Respiratory syncytial virus A and B | ||||
| B tube | Human parainfluenza virus types 1, 2 and 3 | |||
| Influenza B virus | ||||
| GBDS-IQC-309 | Respiratory pathogens multiple nucleic acid detection quality NIST
control products
(Mix 3) |
\ |
Influenza A virus (H1N1, H3N2, etc.) |
0.5mL/ tube, 20 tubes/kit |
| Influenza B virus | ||||
| Respiratory syncytial virus A and B | ||||
| COVID-19 | ||||
| GBDS-IQC-310 | Respiratory pathogens multiple nucleic acid detection quality NIST
control products
(Mix 4) |
\ |
Human parainfluenza virus types 1, 2 and 3 |
0.5mL/ tube, 20 tubes/kit |
| Adenovirus | ||||
| Respiratory syncytial virus A and B |
(2) Indoor quality NIST control product for multiple nucleic acid detection of respiratory pathogens - combined type
| Number | Product Name | Composition of analyte | Quantity | Specification |
|
GBDS-IQC-311 |
Respiratory pathogens multiple nucleic acid detection quality NIST
control products
(Combination A) |
Influenza A virus nucleic acid quality NIST control products | 1 tube |
0.5mL/tube 7 tubes/kit |
| B influenza virus nucleic acid quality NIST control products | 1 tube | |||
| Respiratory syncytial virus A nucleic acid quality NIST control products | 1 tube | |||
| Respiratory syncytial virus B type nucleic acid quality NIST control products | 1 tube | |||
| Human parainfluenza virus nucleic acid (PIV1 RNA) quality NIST control products | 1 tube | |||
| Human parainfluenza virus nucleic acid (PIV3 RNA) quality NIST control products | 1 tube | |||
| Adenovirus nucleic acid (ADV DNA) quality NIST control products | 1 tube | |||
|
GBDS-IQC-312 |
Quality NIST control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination B) | Influenza A virus nucleic acid quality NIST control products | 1 tube |
0.5 mL/tube 6 tubes/kit |
| B influenza virus nucleic acid quality NIST control products | 1 tube | |||
| Adenovirus deoxyribonucleic acid (ADV DNA) quality NIST control products | 1 tube | |||
| Rhinovirus nucleic acid quality NIST control products | 1 tube | |||
| Respiratory syncytial virus nucleic acid quality NIST control products | 1 tube | |||
| Mycoplasma pneumoniae nucleic acid (MP DNA) quality NIST control | 1 tube | |||
|
GBDS-IQC-313 |
Quality NIST control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination C) | Influenza A virus nucleic acid quality NIST control products | 1 tube |
0.5 mL/tube 7 tubes/kit |
| B influenza virus nucleic acid quality NIST control products | 1 tube | |||
| Respiratory syncytial virus A nucleic acid quality NIST control products | 1 tube | |||
| Respiratory syncytial virus B type nucleic acid quality NIST control products | 1 tube | |||
| Novel coronavirus nucleic acid quality NIST control products | 1 tube | |||
| Influenza A H1N1 virus nucleic acid (HIN1 RNA) quality NIST control products | 1 tube | |||
| Influenza A H3N2 virus nucleic acid (H3N2 RNA) quality NIST control product | 1 tube | |||
|
GBDS-IQC-314 |
Respiratory pathogens multiple nucleic acid detection quality NIST
control products
(Combination D) |
Human parainfluenza virus nucleic acid (PIV1 RNA) quality NIST control products | 1 tube |
0.5 mL/tube 6 tubes/kit |
| Human parainfluenza virus nucleic acid (PIV2 RNA) quality NIST control products | 1 tube | |||
| Human parainfluenza virus nucleic acid (PIV3 RNA) quality NIST control products | 1 tube | |||
| Adenovirus nucleic acid (ADV DNA) quality NIST control products | 1 tube | |||
| Respiratory syncytial virus A nucleic acid quality NIST control products | 1 tube | |||
| Respiratory syncytial virus B type nucleic acid quality NIST control products | 1 tube |
(3) Room Quality NIST control/Blind Sample Quality Assessment (EQA)
| Number | Product Name | Composition of analyte | Quantity | Specification |
| GBDS-EQA-065 | Interlaboratory quality assessment for multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube 7 tubes/kit |
It is composed of different pathogen quality NIST control products, including positive quality NIST control products, negative quality NIST control products and specific quality NIST control products |
Blind comparison of multiple nucleic acid detection reagents for respiratory pathogens in different laboratories |
Note: Customized products can be provided according to the detection of different combinations of respiratory pathogens.
(4) Performance Verification Reference (PT)
| Number | Product Name | Composition of analyte | Quantity | Specification |
| GBDS-CKP-038 | Reference for performance verification of multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube |
Different pathogen quality NIST
control components, including:
Positive coincidence rate, sensitivity (detection limit), specificity, precision, interference substance reference |
Performance verification and evaluation of multiple nucleic acid detection reagents for respiratory pathogens |
Note: Customized products can be provided according to the detection of different combinations of respiratory pathogens.
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