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
YY/T 1177-2010
Cancer antigen CA72-4 quantitative detection reagent (kit) - Chemiluminescent immunoassay
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Cancer Antigen CA72-4 quantitative assay reagent (kit)
Chemiluminescence immunoassay
CancerantigenCA72-4quantitativedetectionreagent (kit) -
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is to evaluate the cancer antigen CA72-4 (CancerAntigen72-4, CA72-4) quantitative assay reagent (kit) (chemiluminescence immunoassays
Chromatography) product quality basis.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Beijing Chemclin Biotechnology Co., Ltd., Roche Diagnostics (Shanghai)
Limited.
The main drafters. Zhang Xinmei, Cheng Yinghao, Tao Yuan, Du Haiou.
Cancer Antigen CA72-4 quantitative assay reagent (kit)
Chemiluminescence immunoassay
1 Scope
This standard specifies the cancer antigen CA72-4 quantitative assay reagent (kit) (chemiluminescent immunoassay) classification, requirements, test methods,
Logos, labels, brochures, packaging, transportation and storage.
This standard applies to the principles of quantitative determination of carcinoembryonic antigen CA72-4 reagent (kit) to CLIA law [hereinafter referred to as
"CA72-4 reagent (kit)"]. Including microplates, tubes, magnetic particles, beads and plastic beads as the carrier of enzymatic and non-enzymatic chemiluminescence Free
Phytophthora analysis assay reagent (kit).
This standard does not apply to.
a) to be used for sales of individual tumor markers and tumor marker substance calibrator control products.
b) by CLIA for the principle of biochips.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 21415-2008 vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrology
Traceability
Category 3
CA72-4 reagent (box) in accordance with the principle of chemiluminescence can be divided into enzymatic and non-enzymatic chemiluminescence immunoassay reagent (kit); solid basis
In phase carrier it can be divided into microplates, tubes, magnetic particles, beads and plastic beads as the carrier chemiluminescence immunoassay reagent (kit); according to the operating
As the process can be divided into different manual method and automated method of automatic operation.
4 Requirements
4.1 Appearance
Appearance should meet the following requirements.
a) reagent (box) of each component should be complete, complete, no liquid leakage;
b) packaging labels should be clear and easy to identify.
4.2 Traceability
Manufacturers should provide with CA72-4 calibrator sources, the assignment process and measured according to GB/T 21415-2008 and the relevant provisions
Uncertainty and so on.
4.3 Accuracy
Accuracy should meet one of the requirements are as follows.