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YY/T 1177-2010 English PDF (YYT1177-2010)

YY/T 1177-2010 English PDF (YYT1177-2010)

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YY/T 1177-2010: Cancer antigen CA72-4 quantitative detection reagent (kit) - Chemiluminescent immunoassay

This Standard specifies the classification, requirements, test methods, marking, labeling, instruction manual, packaging, transportation, and storage of the cancer antigen CA72-4 quantitative detection reagent (kit) (chemiluminescent immunoassay).
YY/T 1177-2010
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
Cancer antigen CA72-4 quantitative detection
reagent (kit) - Chemiluminescent immunoassay
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marking, labeling, and instruction manual ... 9
7 Packaging, transportation, and storage ... 11
References ... 12
Foreword
This Standard was drafted according to the rules specified in GB/T 1.1-2009. This Standard is the basis for evaluating the product quality of CA72-4 (Cancer Antigen 72-4, CA72-4) quantitative determination reagent (kit) (chemiluminescent immunoassay).
Please note that some contents in this document may involve patents. The issuing authority of this document does not undertake the responsibilities 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 Chemclin Biotech Co., Ltd., and Roche Diagnostic Products (Shanghai) Co., Ltd.
Main drafters of this Standard. Zhang Xinmei, Cheng Yinghao, Tao Yuan, and Du Haiou.
Cancer antigen CA72-4 quantitative detection reagent (kit)
- Chemiluminescent immunoassay
1??Scope
This Standard specifies the classification, requirements, test methods, marking, labeling, instruction manual, packaging, transportation, and storage of the cancer antigen CA72-4 quantitative detection reagent (kit) (chemiluminescent immunoassay). This Standard applies to the quantitative detection of cancer antigen CA72-4 reagent (kit) [hereinafter referred to as ?€?CA72-4 reagent (kit)?€?] based on the principle of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with the carriers such as microplates, pipes, magnetic particles, microbeads, and plastic beads.
The Standard does not apply to.
a) The tumor marker calibrator and tumor marker quality control materials intended for separate sales.
b) Biochip in the principle of chemiluminescent immunoassay.
2??Normative??references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply 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 (ISO 17511.2003, IDT)
3??Classification
CA72-4 reagent (kit) can be divided into enzymatic and non-enzymatic
chemiluminescent immunoassay detection reagent (kit), according to different chemiluminescence principles. According to different solid-phase carriers, it can be divided into enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers such as microplates, pipes, magnetic particles, microbeads, and plastic beads. According to different operation processes, it can be divided into manual operation method and automatic operation method of instrument.
CV ?€? Coefficient of variation;
SD ?€? Standard deviation of the measured results for 10 times;
M ?€? Mean of the measured results for 10 times.
5.8 Stability
It can choose the following methods to perform verification.
a) Stability within the period of validity. TAKE the expired sample to inspect according to the methods of 5.3-5.6. It shall comply with the requirements of 4.8 a).
b) Thermal stability test. TAKE the sample within the period of validity to place for 3 days under the condition of 37??C. PERFORM the detection according to the methods of 5.3-5.6. It shall comply with the requirements of 4.8 b).
6??Marking,??labeling,??and??instruction??manual
6.1 Marking and labeling of reagent?€?s (kit) outer packing
It shall include at least the following contents.
a) Product name and package specifications;
b) Name, address, contact details of manufacturing enterprise or after-sales service organization;
c) Medical device registration certificate number
d) Product standard number;
e) Product batch number;
f) Expiry date;
g) Storage conditions.
6.2 Marking and labeling of reagent?€?s (kit) each component?€?s packing
It shall include at least the following contents.
a) Product name and package specifications;
b) Name or logo of manufacturing enterprise;
c) Product batch number;
v) Instructions approval and modification date.
7??Packaging,??transportation,??and??storage
7.1 Packaging
Reagents (kit) shall be packaged according to the requirements of manufacturing enterprise.
6.2 Transportation
Reagents (kit) shall be transported according to the requirements of manufacturing enterprises.
6.3 Storage
Reagent (kit) shall be stored under the conditions specified by manufacturing enterprises.
References
[1] GB/T 191 Packaging - Pictorial marking for handling of goods
[2] GB/T 9969 General principles for preparation of instructions for use of industrial products
[3] YY 0466 Medical devices - Symbols to be used with medical device labels labeling and information to be supplied (ISO 15223-2000, IDT)
[4] GB/T 19702-2005 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193.2002, IDT)
[5] ISO/DIS 18113-1 Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labeling) - Part 1. Terms, definitions and general requirements

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