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YY/T 1177-2010

Chinese Standard: 'YY/T 1177-2010'
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Detail Information of YY/T 1177-2010; YY/T1177-2010
Description (Translated English): Cancer antigen CA72-4 quantitative detection reagent (kit) - Chemiluminescent immunoassay
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 10,194
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 21415-2008
Drafting Organization: Beijing Medical Device Testing
Administrative Organization: National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Proposing organization: National laboratories and in vitro diagnostic medical systems Clinical Laboratory Standardization Technical Committee (SAC/TC 136)
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the cancer antigen CA72-4 quantitative determination reagent (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to chemiluminescence immunoassay for the quantitative determination of human carcinoembryonic antigen principle CA72-4 reagent (box). Including microplates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non- enzymatic chemiluminescence immunoassay reagent (box). This standard does not apply to: a) intended to be used tumor markers sold separately tumor marker substance calibrators and control products, b) to chemiluminescent immunoassay for the principle of bio- chips.

YY/T 1177-2010
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Cancer antigen CA72-4 quantitative detection
reagent (kit) - Chemiluminescent immunoassay
癌抗原 CA72-4 定量测定试剂(盒)
化学发光免疫分析法
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 principl......
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