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YY/T 1233-2014 English PDF (YYT1233-2014)

YY/T 1233-2014 English PDF (YYT1233-2014)

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YY/T 1233-2014: Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)

This Standard specifies the terms and definitions, requirements, test methods, marking, labeling, instructions, packaging, transportation, and storage of cardiac troponin-I (cTnI) quantitative detection reagent (kit) (chemiluminescent immunoassay). This Standard applies to the quantitative detection of human cardiac troponin-I (cTnI) quantitative detection reagent (kit) by the principal of chemiluminescent immunoassay, including the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers such as microplates, tubes, and magnetic particles. This Standard does not apply to the requirements for the calibrator and control materials in reagent (kit).
YY/T 1233-2014
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
Cardiac troponin-I (cTnI)
quantitative detection reagent (kit)
(Chemiluminescent immunoassay)
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and instructions ... 9
7 Packaging, transportation and storage ... 11
Foreword
This Standard was drafted according to the rules given by GB/T 1.1-2009. Please note that some contents of this Document may involve patents. The issuing authority of this Document does not undertake the responsibility for the identification of these patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of the Standardization Technical Committee of National Medical Clinical Test Laboratory and in Vitro Diagnostic System (SAC/TC 136).
Main drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Zhengzhou Auto Biological Engineering Co., Ltd., Beckman Coulter Trading (China) Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., and Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd.
Main drafters of this Standard. Wang Ruixia, Li Xiaoxia, Zhang Jinwen, Du Haiou, Liu Rong, Wang Xuefeng, and Qi Xin.
Cardiac troponin-I (cTnI)
quantitative detection reagent (kit)
(Chemiluminescent immunoassay)
1??Scope
This Standard specifies the terms and definitions, requirements, test methods, marking, labeling, instructions, packaging, transportation, and storage of cardiac troponin-I (cTnI) quantitative detection reagent (kit) (chemiluminescent immunoassay).
This Standard applies to the quantitative detection of human cardiac troponin-I (cTnI) quantitative detection reagent (kit) [hereinafter referred to as "cTnI reagent (kit)"] by the principal of chemiluminescent immunoassay, including the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers such as microplates, tubes, and magnetic particles.
This Standard does not apply to the requirements for the calibrator and control materials in reagent (kit).
2??Normative??references
The following document is essential for the application of this Document. For dated references, only dated versions apply to this Document. For undated references, the latest version (excluding corrections) applies to this Document.
GB/T 21415 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrator and control materials
3??Terms??and??definitions
The following terms and definitions apply to this Document.
3.1
limit of blank; LOB
In claimed probability, the highest measurement result of blank sample that can be observed.
[NCCLS, EP17]
4??Requirements
4.1 Appearance
Appearance shall meet the following requirements.
a) Each component of reagent (kit) shall be complete, intact, and no leakage of liquid;
b) Chinese packaging labels shall be clear, without wear and tear.
4.2 Traceability
Manufacturing enterprise shall provide the contents such as source, traceable assignment process, corresponding requirements, and uncertainty of the cTnI calibrator used, according to GB/T 21415 and the relevant provisions.
4.3 Accuracy
Accuracy shall meet one of the following requirements.
a) USE reference material as the sample to perform detection. The relative deviation of measurement results shall be within the interval of ?? 20%. b) ADD the cardiac troponin-I (cTnI) of known concentration INTO the blood matrix or other body fluid components. The recovery rate shall be within the interval (85%~115%).
4.4 Blank limit
It shall meet the requirements of the manufacturer, and not higher than the upper limit of the reference interval of normal people.
4.5 Linear interval
The upper limit of linear interval shall not be lower than 25ng/mL; the lower limit shall be lower than the reference interval of normal people. Within the linear interval specified by manufacturing enterprise, the correlation coefficient of reagent kit |r| shall be ???0.990.
4.6 Repeatability
USE the sample of which the critical value of acute myocardial infarction is at ?? 50% level, to test repeatedly for 10 times. Its coefficient of variation (CV) shall not exceed 10% (instrument automatic operation method) or not more than 15% (manual operation method).
r) Manufacturing enterprise;
s) License number of medical device manufacturing enterprise;
t) Medical device registration certificate number;
u) Product standard number;
v) Instructions?€? approval and modification date.
7??Packaging,??transportation??and??storage
7.1 Packaging
It shall be intact, no leak, and no damage.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of manufacturing enterprise.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by manufacturing enterprise.

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