YY/T 1247-2014Hepatitis B virus surface antigen(HBsAg)detection reagent(kit)(Chemiluminescent immunoassay) (English PDF)
乙型肝炎病毒表面抗原测定试剂（盒）（化学发光免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1247-2014 is the English-translated version of 乙型肝炎病毒表面抗原测定试剂（盒）（化学发光免疫分析法）.
YY/T 1247-2014 is the Chinese pharmaceutical industry standard for the reagent kit that detects the surface antigen of hepatitis B virus by chemiluminescent immunoassay.
It specifies the technical requirements, the test methods, the marks, the labels, the instructions and the rules for packaging, transport and storage, covering the detection limit, the agreement with the national reference materials, the specificity, the precision, the hook effect and the stability of the reagent. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1247-2014
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Requirements4
- 4 Test methods8
- 5 Marks, labels and instructions11
- 6 Packaging, transportation and storage13
- Bibliography14
Foreword
This Standard is drafted according to the rules specified in GB/T 1.1-2009.
1 Scope
This Standard specifies the technical requirements, test method, marks, labels, instructions, packaging, transportation, and storage of the hepatitis B virus surface antigen (HBsAg) detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the reagent (kit) that utilizes the chemiluminescent analysis technique, and adopts the double antibody sandwich method to qualitatively or quantitatively measure the hepatitis B virus surface antigen (hereinafter referred as "HBsAg") reagent (kit) in human's serum and plasma. It includes chemiluminiscence, electrochemiluminescence and time-resolved fluorescence etc. This Standard does not apply to.
a) The calibrator of surface antigen of hepatitis B virus that is marketed independently, and the quality control materials of surface antigen of hepatitis B virus;
b) Biochip in the principle of chemiluminescent immunoassay.
2 Normative references
The articles contained in the following documents have become part of this Document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document.
GB/T 21415 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
3 Requirements
3.1 Quantitative determination reagent (kit)
3.1.1 Appearance
It shall meet the following requirements. […]
3.1.3 Accuracy
When using the national reference materials HBsAg or the standard national reference materials as the sample to take the test, the relative deviation of test result shall be within the range of ±20%.
3.1.4 Coincidence rate of positive reference material
USE national reference materials or positive reference materials that has been calibrated by national reference materials to perform the detection. It must not be negative.
3.1.6 Minimum detection limit
USE national reference materials HBsAg or reference materials that has been calibrated by national reference materials to perform the detection.
3.1.7 Linearity
The linear range specified by the manufacturing enterprise shall at least cover 5.9 IU/mL-100.0 IU/mL. Within the linear range specified by the manufacturing enterprise, the correlation coefficient r shall not be lower than 0.9900.
3.1.8 Precision
3.1.8.1 Repeatability
USE national reference materials or precision reference materials (1 IU/mL) that has been calibrated by national reference materials to repeatedly test for 10 times. Its coefficient of variation (CV) shall not be higher than 15%.
3.1.9 Stability
The following methods can be used for verification.
3.2 Qualitative determination reagent (kit)
3.2.1 Appearance
The following requirements shall be met.
3.2.2 Coincidence rate of positive reference material
USE national reference materials or positive reference materials that has been calibrated by national reference materials to perform the test. It must not be negative.
3.2.3 Coincidence rate of negative reference material
USE national reference materials or negative reference materials that has been calibrated by national reference materials to perform the test. It must not be positive.
3.2.5 Precision
3.2.5.1 Repeatability
USE national reference materials or precision reference materials (1 IU/mL) that has been calibrated by national reference materials to repeatedly test for 10 times. Its coefficient of variation (CV) shall not be higher than 15%.
3.2.6 Stability
The following methods can be used for verification.
4 Test methods
4.1 Quantitative determination reagent (kit)
4.1.1 Appearance
Visually inspect with normal vision under the natural light. It shall meet the requirements of 3.1.1.
4.1.5 Coincidence rate of negative reference material
TEST 20 sets of national reference materials or negative reference materials that has been calibrated by national reference materials. Operate according to the reagent (kit) instructions' steps. Judge according to the instructions. The result shall meet the requirements of 3.1.5.
4.1.6 Minimum detection limit
TEST the national reference materials HBsAg or sensitivity reference materials that has been calibrated by national reference materials. Operate according to the reagent (kit) instructions' steps. Judge according to the instructions. The result shall meet the requirements of 3.1.6.
4.1.8 Precision
4.1.9 Stability
4.1.9.1 Stability within the validity. Take the expired-sample to perform the test according
to the methods of 4.1.3-4.1.8.1. It shall meet the requirements of 3.1.9 a).
4.1.9.2 Thermal stability test. The sample within the period of validity, according to thermal stability conditions provided by the manufacturing enterprise, shall be tested according to the methods of 4.1.3-4.1.8.1. It shall meet the requirements of 3.1.9 b).
4.2 Qualitative determination reagent (kit)
4.2.1 Appearance
Visual inspect with normal vision under the natural light. It shall meet the requirements of 3.2.1.
4.2.2 Coincidence rate of positive reference material
USE national reference materials or positive reference materials that has been calibrated by national reference materials to test 3 sets of HBsAg positive reference materials of which the concentration is higher than 5 x 10^4 IU/mL. Judge according to the instructions. The result shall meet the requirements of 3.2.2.
4.2.5 Precision
4.2.5.1 Repeatability
USE national reference materials HBsAg or precision reference materials (1 IU/mL) that has been calibrated by national reference materials to perform the test. Repeat the test for 10 times. USE the luminescent signal value of the sample OR the ratio (S/CO) of sample signal and Cut-off to calculate the average value (mean x) and standard deviation (SD) of the 10 times measurement results. Calculate the coefficient of variation (CV) according to formula (2). The result shall meet the requirements of 3.2.5.1.
4.2.6 Stability
4.2.6.1 Stability within the validity. Take the expired-sample to perform the test according
to the methods of 4.2.2-4.2.5.1. It shall meet the requirements of 3.2.6 a).
4.2.6.2 Thermal stability test. The sample within the period of validity, according to thermal stability conditions provided by the manufacturing enterprise, shall be tested according to methods of 4.2.2-4.2.5.1. It shall meet the requirements of 3.2.6 b).
5 Marks, labels and instructions
5.1 Marks and labels for outer packing
It shall contain at least the following contents. […]
5.2 Packaging marks and labels of each component
It shall contain at least the following contents. […]
5.3 Operating instructions
It shall contain at least the following contents. […]
6 Packaging, transportation and storage
6.1 Packaging
It shall be packaged according to the requirements of manufacturing enterprise.
6.2 Transportation
It shall be transported according to the requirements of manufacturing enterprise. […]
......
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Related Standards
GB/T 21415-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 21415-2025 — In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
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