YY/T 1178-2010 English PDF (YYT1178-2010)

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YY/T 1178-2010: Carbohydrate antigen CA19-9 quantitative detection reagent(kit) - Chemiluminescent immunoassay
YY/T 1178-2010
Carbohydrate antigen CA19-9 quantitative detection reagent (kit) - Chemiluminescent immunoassay
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Carbohydrate antigen CA19-9 quantitative assay reagent (kit)
Chemiluminescence immunoassay
CarbohydrateantigenCA19-9quantitativedetectionreagent (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.
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., Johnson and Johnson (Shanghai) Medical Devices
Ltd., Switzerland Abbott Laboratories Ltd. Beijing Office.
The main drafters. Zhang Xinmei, Cheng Yinghao, Qi Xin, Wang Xuefeng.
Carbohydrate antigen CA19-9 quantitative assay reagent (kit)
Chemiluminescence immunoassay
1 Scope
This standard specifies the carbohydrate antigen CA19-9 quantitative assay reagent (kit) (chemiluminescent immunoassay) classification, requirements, test side
France, logos, labels, brochures, packaging, transportation and storage.
This standard applies to the principles of quantitative determination of chemiluminescence immunoassay for the carbohydrate antigen (CA19-9) reagent (box) [hereinafter referred to as
"CA19-9 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
CA19-9 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 carbohydrate antigen CA19-9 calibrator sources according to GB/T 21415-2008 and the relevant provisions, the assignment had
Cheng and measurement uncertainty and so on.
4.3 Accuracy
Accuracy should meet one of the requirements are as follows.