YY/T 1175-2010 English PDF (YY/T1175-2010)

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YY/T 1175-2010: Quantitative detection reagent (kit) for tumor markers - Chemiluminescent immunoassay
YY/T 1175-2010
Quantitative detection reagent (kit) for tumor markers - Chemiluminescent immunoassay
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Quantitative determination of tumor marker reagent (box)
Chemiluminescence immunoassay
Quantitativedetectionreagent (kit) fortumormarkers-
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.
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., Beijing Tak source of Biomedical Engineering
Cheng Co., Roche Diagnostics (Shanghai) Co., Ltd., Siemens Medical Diagnostics (Shanghai) Co., Ltd.
The main drafters. Zhang Xinmei, Cheng Yinghao, Yang Xiaolin, Duhai Ou, Cai Xiaorong, Zhu Wei Chan.
Quantitative determination of tumor marker reagent (box)
Chemiluminescence immunoassay
1 Scope
This standard specifies the terms quantitative determination of tumor markers reagent (box) (chemiluminescent immunoassay) [hereinafter referred to as "reagent (kit)"] of
And definitions, classification, requirements, test methods, marking, labeling, instructions, packaging, transport and storage.
This standard applies to human tumor marker reagent (box) quantitative determination principle to CLIA law. Including microplates,
Tubes, magnetic particles, beads and plastic beads as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay 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
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Tumor markers tumormarker, TM
In tumorigenesis and proliferation process, by the tumor cells or other cells or secreted and released into the blood, body fluids, cells or tissues,
And reflect the existence of tumor growth, and may biochemistry, immunology and molecular biology methods such as the determination of a class of substances (including protein
Quality, hormones, enzymes and polyamines, etc.).
3.2
Chemiluminescence chemiluminescence, CL
Since the electron energy levels of a chemical reaction in the excited state of matter, photons generated by the release of energy transition, resulting in light emission
phenomenon.
3.3
CLIA chemiluminescentimmunoassay, CLIA
It is a chemiluminescent immunoassay and combine technology, a series of immune response by an antigen or antibody labeled with the analytes,
Finally, to determine the luminous intensity derived analyte content.
3.4
Tumor marker kits kitfortumormarkers
Intended for the completion of the detection of tumor markers packaged with a bundle of points.