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YY/T 1791-2021: Hepatitis B virus e antibody (HBeAb) detection reagent kit (luminescent immunoassay)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1791-2021 | English | 219 |
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Hepatitis B virus e antibody (HBeAb) detection reagent kit (luminescent immunoassay)
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YY/T 1791-2021
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Basic data | Standard ID | YY/T 1791-2021 (YY/T1791-2021) | | Description (Translated English) | Hepatitis B virus e antibody (HBeAb) detection reagent kit (luminescent immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 11,154 | | Issuing agency(ies) | State Drug Administration | YY/T 1791-2021: Hepatitis B virus e antibody (HBeAb) detection reagent kit (luminescent immunoassay)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Hepatitis B virus e antibody (HBeAb) detection reagent kit (luminescent immunoassay)
ICS 11:100:10
C44
People's Republic of China Pharmaceutical Industry Standard
Hepatitis B virus e antibody detection kit
(Luminescence Immunoassay)
Published on 2021-12-06
2023-05-01 Implementation
Released by the State Drug Administration
foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that some content of this document may be patented: The issuing authority of this document assumes no responsibility for identifying these patents:
This standard is proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136):
This standard was drafted by: China National Institute for Food and Drug Control, Shanghai Clinical Testing Center, Abbott Trading (Shanghai) Co:, Ltd:, Kemei
Diagnostic Technology Co:, Ltd:, Zhengzhou Antu Bioengineering Co:, Ltd:, Mike Biotech Co:, Ltd:
The main drafters of this standard: Li Kejian, Zhu Yuqing, Wang Xuefeng, Wang Jianmei, Li Guilin, Long Tengxiang:
Hepatitis B virus e antibody detection kit
(Luminescence Immunoassay)
1 Scope
This standard specifies the technical requirements, test methods, labeling, labeling of hepatitis B virus e antibody detection kit (luminescence immunoassay)
label, instruction manual, packaging, transportation and storage, etc:
This standard is applicable to the quantitative or qualitative detection of hepatitis B disease in human serum and plasma using the principle of competition method and luminescence analysis technology:
Kit for HBeAb (hereinafter referred to as "HBeAb"): Including chemiluminescence, microparticle chemiluminescence, electrochemiluminescence, photoexcited chemiluminescence
and time-resolved fluorescence:
This standard does not apply to:
a) HBV e-antibody calibrators and HBV e-antibody quality control products intended to be sold separately;
b) Biochip based on the principle of luminescence immunoassay:
2 Normative references
The following documents are essential for the application of this document: For dated references, only the dated version applies to this article
pieces: For undated references, the latest edition (including all amendments) applies to this document:
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 21415 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices
origin
GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use
3 Requirements
3:1 Quantitative detection kit
3:1:1 Appearance
The following requirements should be met:
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) Chinese packaging labels should be clear and not damaged:
3:1:2 Traceability
The manufacturer should provide the source, assignment method and uncertainty of the calibrator used in accordance with GB/T 21415 and related regulations:
3:1:3 Accuracy
For testing with HBeAb national standard or enterprise standard standardized by national standard, the relative deviation of the measurement results should not be
greater than ±20%:
3:1:4 Conformance rate of positive reference products
Use the HBeAb national reference product or the enterprise positive reference product standardized by the national reference product for testing, if the test result is false negative, it will not be detected:
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