Search result: YY/T 1183-2024 (YY/T 1183-2010 Older version)
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Detection reagent kit for enzyme-linked immunoabsorbent assay
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YY/T 1183-2024
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Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
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YY/T 1183-2010
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| Standard ID | YY/T 1183-2024 (YY/T1183-2024) | | Description (Translated English) | Detection reagent kit for enzyme-linked immunoabsorbent assay | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 14,196 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 1183-2010 | | Issuing agency(ies) | National Drug Administration | | Summary | This standard specifies the requirements, identification, labeling and instructions for use, packaging, transportation and storage of enzyme-linked immunosorbent assay test kits, and specifies the corresponding test methods. This standard applies to quantitative or qualitative test kits that are tested in medical laboratories based on the principle of enzyme-linked immunosorbent assay. |
YY/T 1183-2024.Enzyme-linked immunosorbent assay kit
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1183-2010
ELISA kit
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 1183-2010 "Enzyme-linked immunosorbent assay reagent (kit)". Compared with YY/T 1183-2010,
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Added "analytical specificity"; deleted "inner packaging", "outer packaging (sales packaging)", "label", "batch", "batch number", "metrological traceability"
"Recovery", "limit of detection", "linearity of a measurement system", "repeatability", "expiration date", "stability", "critical value" and other terms.
and definitions (see 3.3, 3.3~3.16 of the.2010 edition);
--- Deleted the classification (see Chapter 4 of the.2010 edition);
--- Changed the accuracy requirements of quantitative detection and the corresponding detection methods (see 4.1.3 and 5.1.3, 5.1.3 and
6.1.3);
--- Changed the requirements for the detection limit of quantitative detection and the corresponding detection method (see 4.1.4 and 5.1.4, 5.1.4 and
6.1.4);
--- Changed the requirements for linearity of quantitative detection and the corresponding detection methods (see 4.1.5 and 5.1.5, 5.1.5 and 5.1.5 of the.2010 edition)
6.1.5);
--- Added requirements for analytical specificity of quantitative detection and corresponding detection methods (see 4.1.6 and 5.1.6);
--- Changed the requirements for repeatability of quantitative testing and the corresponding test methods (see 4.1.7 and 5.1.7, 5.1.6 and
6.1.6);
--- Changed the requirements for batch differences in quantitative testing and the corresponding test methods (see 4.1.8 and 5.1.8, 5.1.7 and
6.1.7);
--- Changed the requirements for stability of quantitative detection and the corresponding detection methods (see 4.1.9 and 5.1.9, 5.1.8 and
6.1.8);
--- Changed the requirements for the conformity rate of negative reference materials for qualitative testing and the corresponding test methods (see 4.2.2 and 5.2.2,.2010 edition
5.2.2 and 6.2.2);
--- Changed the requirements for the compliance rate of positive reference materials for qualitative testing and the corresponding test methods (see 4.2.3 and 5.2.3,.2010 edition
5.2.3 and 6.2.3);
--- Added the requirements for analytical specificity of qualitative detection and the corresponding detection methods (see 4.2.4 and 5.2.4);
--- Changed the requirements for the detection limit of qualitative detection and the corresponding detection methods (see 4.2.5 and 5.2.5, 5.2.4 and
6.2.4);
--- Changed the requirements for repeatability of qualitative testing and the corresponding test methods (see 4.2.6 and 5.2.6, 5.2.5 and
6.2.5);
--- Changed the requirements for batch differences and corresponding test methods for qualitative testing (see 4.2.7 and 5.2.7, 5.2.6 and
6.2.6);
--- Changed the requirements for stability of qualitative testing and the corresponding test methods (see 4.2.8 and 5.2.8, 5.2.7 and
6.2.7);
--- Changed the identification, labeling and instructions for use (see Chapter 6, Chapter 7 of the.2010 edition);
--- Changed packaging, transportation and storage (see Chapter 7, Chapter 8 of the.2010 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), Beijing Medical
Medical Device Evaluation and Inspection Center, China Customs Science and Technology Research Center, Beijing Wantai Biopharmaceutical Co., Ltd., Zhengzhou Antu Biotechnology
Cheng Co., Ltd.
The main drafters of this document. Li Xiao, Xu Songyan, Zhao Qiang, Wang Yikai, Liu Xin, Shi Qiaoyun, and Jin Lindan.
This document was first published in.2010 and this is the first revision.
ELISA kit
1 Scope
This document specifies the requirements, identification, labeling and instructions for use, packaging, transportation and storage of enzyme-linked immunosorbent assay test kits.
The corresponding test methods were developed.
This document is applicable to quantitative or qualitative test kits (hereinafter referred to as "ELISA") that are tested in medical laboratories based on the principle of enzyme-linked immunosorbent assay.
referred to as a "kit").
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 191 Pictorial markings for packaging, storage and transportation
GB/T 21415 Metrological traceability of values assigned to calibrators and control materials for the measurement of quantities in biological samples of in vitro diagnostic medical devices
Origin
GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
A solid phase adsorption test method that uses enzymes as marker indicators, based on antigen-antibody reactions, and determines the results by the color development of the chromogen.
The degree of color development is expressed by the absorbance (A) value, and the measured absorbance (A) value is correlated with the level of the antigen or antibody to be tested.
Note. Solid phase carriers include microtiter plates, tubes, magnetic particles, microbeads, plastic beads and other carriers.
3.2
A group of components used to complete specific in vitro diagnostic tests based on the principle of enzyme-linked immunosorbent assay.
Note. Includes coated solid phase carrier, antibody, antigen, biotin conjugate, enzyme conjugate, buffer, color development system, diluent, calibrator, quality control product, etc.
3.3
The ability of a detection procedure to detect or measure the presence of a measurand only when other quantities are present in the sample.
[Source. GB/T 29791.1-2013, A.2.6]
4 Requirements
4.1 Requirements for ELISA quantitative detection kits
4.1.1 Appearance
The appearance should meet the following requirements.
......
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...
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