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YY/T 1513-2017 English PDF (YYT1513-2017)

YY/T 1513-2017 English PDF (YYT1513-2017)

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YY/T 1513-2017: C-reactive protein testing kit

This Standard specifies the classification, requirements, test method, marking, instructions for use, packaging, transportation and storage for C-reactive protein testing kits. This Standard applies to kits for quantitative determination of C-reactive protein in blood sample (hereinafter referred to as CRP kits) based on the basic principle of antibody-antigen reaction, including the labeling quantitation immune method [such as electrochemiluminescence] and immunoturbidimetry (such as turbidimetric immunoassay and latex particle-enhanced turbidimetric immunoassay). This Standard does not apply to: evaluate the calibration products and quality control products of C-reactive protein; all types of colloidal immunogold labeling test paper.
YY/T 1513-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.100
C 44
C-reactive protein testing kit
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food And Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification ... 4
4 Requirements... 5
5 Test method ... 7
6 Marking, labelling and instructions for use ... 11
7 Packaging, transportation and storage ... 11
Bibliography ... 12
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuer of this document shall not be held responsible for identifying any or all such patent rights.
This Standard was proposed by China Food And Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee 136 on Medical Clinical Test Laboratories and In Vitro Diagnostic Systems of Standardization Administration of China (SAC/TC 136).
The drafting organizations of this Standard. Beijing Medical Device Testing Institute, Biosino Bio-Technology and Science Inc., Beijing Strong Biotechnologies, Inc., Sysmex Biotechnology (Wuxi) Co., Ltd., Shanghai Rongsheng Biological
Pharmaceutical Co., Ltd.
The main drafters of this Standard. Wang Ruixia, Xia Lingchao, Zhang Xiaorui, Dai Leiying, Zhang Jie, Zhang Zhengqiang.
C-reactive protein testing kit
1 Scope
This Standard specifies the classification, requirements, test method, marking, instructions for use, packaging, transportation and storage for C-reactive protein testing kits.
This Standard applies to kits for quantitative determination of C-reactive protein in blood sample (hereinafter referred to as CRP kits) based on the basic principle of antibody-antigen reaction, including the labeling quantitation immune method [such as electrochemiluminescence] and immunoturbidimetry (such as turbidimetric immunoassay and latex particle-enhanced turbidimetric immunoassay).
This Standard does not apply to.
a) evaluate the calibration products and quality control products of C-reactive protein;
b) all types of colloidal immunogold labeling test paper.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to this document.
GB/T 191, Packaging ?€? Pictorial marking for handling of goods
GB/T 21415, In vitro diagnostic medical devices ?€? Measurement of quantities in biological samples ?€? Metrological traceability of values assigned to calibrators and control materials
GB/T 29791.2, In vitro diagnostic medical devices ?€? Information supplied by the manufacturer (labelling) ?€? Part 2. In vitro diagnostic reagents for professional use 3 Classification
3.1 Classification based on the methodology
Within the linear interval scope, select 2 ~ 3 samples of different concentration levels. The selection of concentration may be based on the reference of medical decision level, representing the normal value and abnormal value levels. Repeat testing on each sample for 10 times and the variable coefficient (CV) shall not be greater than 10%. 4.9 Batch-to-batch difference
Select 2 ~ 3 samples of different concentration levels respectively from 3 batches of CRP kits, then the range of the 3 batches of CRP kits shall not be greater than 15%. 4.10 Stability
4.10.1 General rule
Validity stability and thermal stability can be verified.
4.10.2 Validity stability
The manufacturer shall specify the validity of CRP kits. Take the kits at the end of validity to test their reagent blank absorbance, analytical sensitivity, detection limit, accuracy, linearity, repeatability, etc., and the results shall be as required in 4.3 ~ 4.8. 4.10.3 Thermal stability test
Take the CRP kits within their validity; place aside for a certain time at 37??C; test their reagent blank absorbance, analytical sensitivity, detection limit, accuracy, linearity, repeatability, etc.; and the results shall be as required in 4.3 ~ 4.8. NOTE 1. Thermal stability shall not be used to deduce product validity, unless the deductive formula is used which is based on lots of stability research data.
NOTE 2. Generally, select a product of not more than 1 month when its validity is 1 year; select a product not exceeding half a month when its validity is half a year; and so on. However, if the time exceeds the specified time, it is also acceptable when the product complies with the requirements;
NOTE 3. Select a random combination of the methods specified in 4.10.2 and 4.10.3 based on product characteristics, but the methods selected are preferably capable of verifying the stability of the product to ensure that the product properties comply with the standard requirements within the validity.
5 Test method
5.1 Appearance
Use normal or corrected vision to carry out visual inspection under natural light and 5.10.2 Thermal stability test
Take the CRP kits within their validity; place aside for a specified time at 37??C; carry out test using the method specified in 5.3 ~ 5.8; and the results shall be as required in 4.10.3.
6 Marking, labelling and instructions for use
As specified in GB/T 29791.2.
7 Packaging, transportation and storage
7.1 Packaging
Pictorial marks for packaging, storage and transportation shall be as specified in GB/T 191. The packaging containers shall well sealed and complete without leakage or damage.
7.2 Transportation
CRP kits shall be transported as required by the manufacturer. During the process of transportation, protect them from exposure to damp, heavy loads, direct sunlight, rain and snow and acid-base materials and damage of exterior and interior packaging. 7.3 Storage
CRP kits shall be storage under the conditions as specified by the manufacturer.

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