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YY/T 1233-2024: Cardiac troponin detection reagent kit (labelling immunoassay)
Status: Valid YY/T 1233: Evolution and historical versions
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| YY/T 1233-2024 | English | 199 |
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Cardiac troponin detection reagent kit (labelling immunoassay)
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YY/T 1233-2024
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| YY/T 1233-2014 | English | 140 |
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Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
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YY/T 1233-2014
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Basic data | Standard ID | YY/T 1233-2024 (YY/T1233-2024) | | Description (Translated English) | Cardiac troponin detection reagent kit (labelling immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 10,177 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 1233-2014 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, marking, labeling and instructions for use of cardiac troponin determination kits (labeled immunoassay), as well as packaging, transportation and storage, and specifies the corresponding test methods. This standard applies to kits for in vitro quantitative detection of cardiac troponin I (hereinafter referred to as cTnI) and cardiac troponin T (hereinafter referred to as cTnT) in human serum, plasma or whole blood. Methodologies include enzyme-linked immunosorbent assay, enzymatic and non-enzymatic chemiluminescence, electrochemiluminescence, time-resolved fluorescence immunoassay, etc. | YY/T 1233-2024: Cardiac troponin detection reagent kit (labelling 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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1233-2014
Cardiac Troponin Assay Kit
(Labeled Immunoassay)
Released on 2024-09-29
Implementation on October 15, 2025
The State Drug Administration issued
Foreword
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 1233-2014 "Cardiac Troponin-I Quantitative Determination Reagent (Kit) (Chemiluminescent Immunoassay)" and
Compared with YY/T 1233-2014, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed the appearance requirements (see 4.1, 4.1 of the.2014 edition);
--- Changed the traceability requirements (see 4.2, 4.2 of the.2014 edition);
--- Changed the accuracy requirements (see 4.3, 4.3 of the.2014 edition);
--- Deleted the blank limit requirements (see 4.4 of the.2014 edition);
--- Increased detection limit requirements (see 4.4);
--- Changed the linear interval requirements (see 4.5, 4.5 of the.2014 edition);
--- Changed the repeatability requirements (see 4.6, 4.6 of the.2014 edition);
--- The batch difference requirement was deleted and the batch precision requirement was added (see 4.7, 4.7 of the.2014 edition);
--- Changed the analytical specificity requirements (see 4.8, 4.8 of the.2014 edition);
--- Changed the stability requirements (see 4.9, 4.9 of the.2014 edition);
--- The test method has been changed (see Chapter 5, Chapter 5 of the.2014 edition);
--- Changed the identification, labeling and instructions for use (see Chapter 6, Chapter 6 of the.2014 edition);
--- Changed packaging, transportation and storage (see Chapter 7, Chapter 7 of the.2014 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), Jiangsu Provincial Medical
Medical Device Inspection Institute, China Food and Drug Inspection Institute, Fuwai Hospital of Chinese Academy of Medical Sciences, Xingtong Medical Technology (Suzhou) Co., Ltd.,
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this document are. Wang Ruixia, Zhang Xiaoyan, Yu Ting, Lin Yahui, Wu Heng, Liu Junjun, Wu Xiaojun, and Peng Xu.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2014 as YY/T 1233-2014;
---This is the first revision.
Cardiac Troponin Assay Kit
(Labeled Immunoassay)
1 Scope
This document specifies the requirements for cardiac troponin assay kits (labeled immunoassay), identification, labeling and instructions for use, as well as packaging.
Packaging, transportation and storage, and the corresponding test methods are described.
This document is applicable to the in vitro quantitative detection of cardiac troponin I (hereinafter referred to as cTnI) and cardiac troponin in human serum, plasma or whole blood.
Protein T (hereinafter referred to as cTnT) kit. Methods include enzyme-linked immunosorbent assay, enzymatic and non-enzymatic chemiluminescence, electrochemiluminescence
time-resolved fluorescence immunoassay, etc.
This document does not apply to.
---Qualitative or semi-quantitative reagents labeled with colloidal gold or other methods (such as test strips, biochips, etc.);
--- Various radioimmunoassay or immunoradioactive kits labeled with radioisotopes;
--- cTnI or cTnT calibrators or quality controls intended for sale separately.
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 for in vitro diagnostic medical devices
GB/T 29791.1 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general
Require
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 terms and definitions defined in GB/T 29791.1 and the following apply to this document.
3.1
Cardiac troponin can be stably detected in the peripheral blood of more than 50% of healthy adult males and females.
Troponin, cTn), and the measurement result is greater than or equal to the detection limit, and at the 99th percentile value (99thURL) of the healthy population, the measurement
A measurement method where the coefficient of variation (CV) of the results is less than or equal to 10%.
Note 1.99thURL refers to the URL of the 99th URL (specifically, the average of the 99th and 100th URLs) that arranges the cTn concentration values of apparently healthy people from small to large.
The cTn concentration value is called the 99th percentile value of apparently healthy people.
Note 2.99th URL is the recognized cut-off point for myocardial injury and is also the necessary cut-off value for myocardial infarction.
Note 3.The targets of hs-cTn and conventional cTn detection methods (hereinafter referred to as con-cTn) are both cTn. The difference lies in the sensitivity of the detection system.
Not the substance being tested.
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