YY/T 1183-2010 PDF in English
YY/T 1183-2010 (YY/T1183-2010, YYT 1183-2010, YYT1183-2010)
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Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
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YY/T 1183-2010: PDF in English (YYT 1183-2010) YY/T 1183-2010
Page 1 of 18
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
Page 2 of 18
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
Page 3 of 18
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.
Page 4 of 18
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.
Page 9 of 18
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
Page 10 of 18
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.
Page 11 of 18
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...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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