YY/T 1183-2010 English PDF (YYT1183-2010)

This Standard specifies the general technical requirements for detection reagent (kit) for enzyme-linked immunoabsorbent assay, including terms and definitions, classification, requirements, test methods, labeling, instructions for use, packaging, transportation and storage.

YY/T 1183-2010
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YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Detection reagent (kit) for enzyme-linked
immunoabsorbent assay (ELISA)
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and Definitions ... 4
4 Classification ... 8
5 Requirements ... 8
6 Test methods ... 11
7 marking, labeling and instructions for use ... 16
8 Packaging, transportation and storage ... 18
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Foreword
This Standard was drafted in accordance with rules given in GB/T 1.1-2009. Please note that some of the content of this document may involve patents. The issuing organization of this document does not undertake the responsibility of identifying these patents.
This Standard was proposed by the National Medical Clinical Testing Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136). This Standard shall be under the jurisdiction of the National Medical Clinical Testing Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136).
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Beijing Jinweikai Medical Biotechnology Co., Ltd., Shanghai Fosun Changzheng Medical Science Co., Ltd. AND Beckman Coulter Commercial Enterprise (China) Co., Ltd.
Main drafters of this Standard. Zhang Xinmei, He Xueying, Zhu Wang, Wu Jie and Zhang Jinwen.
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Detection reagent (kit) for
enzyme-linked immunoabsorbent assay
1 Scope
This Standard specifies the general technical requirements for detection reagent (kit) for enzyme-linked immunoabsorbent assay, including terms and definitions, classification, requirements, test methods, labeling, instructions for use, packaging, transportation and storage.
This Standard applies to quantitative/qualitative detection reagent (kit) (hereinafter referred to as "reagent kit") for the principle of enzyme-linked immunosorbent assay in medical laboratories.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.
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
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Enzyme-linked immunoabsorbent assay, ELISA
A solid-phase adsorption test method that uses enzyme as marker indicator, takes antigen-antibody reaction as basis, makes result judgment through coloring degree of color originals. Coloring degree is expressed in value absorbance (A). The measured value A AND the level of antigen or antibody to be tested are in correlation. Note. The solid-phase carriers include microplates, tubes, magnetic particles, beads, plastic beads, etc.
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5.1 Requirements for quantitative detection reagent (kit) for enzyme-linked immunoabsorbent assay
5.1.1 Appearance
Appearance shall meet the following requirements.
a) Every component of reagent (kit) shall be complete, intact, no leakage of liquid; b) Labels shall be clear and legible.
5.1.2 Traceability
Manufacturing enterprises shall provide sources, assignment process, uncertainty, etc. of used calibrators according to GB/T 21415-2008 and relevant specifications. 5.1.3 Accuracy
Accuracy shall meet one of the following requirements.
a) USE the reference material as the sample for detection; the relative deviation of measurement results shall be within a specific range;
b) Recovery. ADD the analyte of a known concentration TO the blood matrix or other body fluid components; the recovery rate shall be within a specific range; c) Comparison. CONDUCT comparison test with the reagent kit on the market or reference methods; the results shall meet the requirements of
corresponding specifications.
5.1.4 Detection limit
It shall meet the requirements of corresponding specifications.
5.1.5 Linearity of a measuring system
Within the linear range specified by the manufacturing enterprise, the correlation coefficient r of reagent kit shall not be less than 0.9900.
5.1.6 Repeatability
USE the samples with 2 concentrations to repeatedly detect for 10 times. The coefficient of variation (CV) obtained by manual operation method or instrument automatic operation method shall meet the requirements of corresponding specifications.
5.1.7 Difference between batches
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USE 3 batches of reagent kits to detect the same sample, the coefficient of variation (CV) among those 3 batches of reagent kits shall meet the requirements of corresponding specifications.
5.1.8 Stability
The following methods can be used to verify.
a) Stability within expiry date. The manufacturing enterprise shall specify the expiry date of products. TAKE the sample within the expiry date to detect the accuracy, detection limit, linearity of a measuring system and repeatability, which shall meet the requirements of 5.1.3 ~ 5.1.6;
b) Thermal stability test. PLACE for a specific time under specific heating condition (such as 37°C). DETECT the accuracy, detection limit, linearity of a measuring system and repeatability, which shall meet the requirements of 5.1.3 ~ 5.1.6.
Note 1. Thermal stability cannot be used to derive the expiry date of products, unless it uses the derivation formula that is established based on a large number of stability study data. Note 2. According to the product characteristics, it can select any arbitrary combination of methods a) and b), but the selected method shall be capable of verifying the stability of the product, so as to ensure that the performance of the product can meet the standard requirements within the expiry date.
5.2 Requirements for qualitative detection reagent (kit) for enzyme-linked immunoabsorbent assay
5.2.1 Appearance
Appearance shall meet the following requirements.
a) Every component of reagent (kit) shall be complete, intact, no leakage of liquid; b) Labels shall be clear and easy to identify.
5.2.2 Compliance rate of negative reference materials
DETECT national negative reference or negative reference provided by the manufacturing enterprise; the compliance rate of negative reference shall meet the requirements of corresponding specifications.
5.2.3 Compliance rate of positive reference materials
DETECT national positive reference or positive reference provided by the manufacturing enterprise; the compliance rate of positive reference shall meet the requirements of corresponding specifications.
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5.2.4 Detection limit
DETECT national reference of detection limit or reference of detection limit provided by the manufacturing enterprise; the result shall meet the requirements of corresponding specifications.
5.2.5 Repeatability
USE reference of repeatability to repeatedly detect for 10 time; the coefficient of variation (CV) shall meet the requirements of corresponding specifications. 5.2.6 Difference between batches
USE 3 batches of reagent kits to detect the same sample; the coefficient of variation (CV) among those 3 batches of reagent kits shall meet the requirements of corresponding specifications.
5.2.7 Stability
The following methods can be used to verify.
a) Stability within expiry date. The manufacturing enterprise shall specify the expiry date of product. TAKE the sample within the expiry date to detect compliance rate of negative reference, compliance rate of positive reference, detection limit and repeatability, which shall meet the requirements of 5.2.2 ~ 5.2.5;
b) Thermal stability test. PLACE for a specific time under specific heating condition (such as 37°C). DETECT compliance rate of negative reference, compliance rate of positive reference, detection limit and repeatability, which shall meet the requirements of 5.2.2 ~ 5.2.5.
Note 1. Thermal stability cannot be used to derive the expiry date of products, unless it uses the derivation formula that is established based on a large number of stability study data. Note 2. According to the product characteristics, it can select any arbitrary combination of methods a) and b), but the selected method shall be capable of verifying the stability of the product, so as to ensure that the performance of the product can meet the standard requirements within the expiry date .
6 Test methods
6.1 Test method for quanti...