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YY/T 1179-2010: Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1179-2010 | English | 229 |
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Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay
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YY/T 1179-2010
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Basic data | Standard ID | YY/T 1179-2010 (YY/T1179-2010) | | Description (Translated English) | Carbohydrate antigen CA50 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 | 10,171 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 21415-2008 | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the quantitative side of the carbohydrate antigen CA50 given 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 principle carbohydrate antigen CA50 reagent (box). Including microplates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non-enzymatic side chemiluminescent immunoassay reagent set (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 1179-2010: Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Carbohydrate antigen CA50 quantitative detection reagent (kit) .Chemiluminescent immunoassay
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Carbohydrate antigen CA50 quantitative assay reagent (kit)
Chemiluminescence immunoassay
CarbohydrateantigenCA50quantitativedetectionreagent (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.
The main drafters. Zhang Xinmei, Cheng Yinghao, Duhai Ou.
Carbohydrate antigen CA50 quantitative assay reagent (kit)
Chemiluminescence immunoassay
1 Scope
This standard specifies the quantitative determination of carbohydrate antigen CA50 reagent (box) (chemiluminescent immunoassay) classification, requirements, test methods,
Logos, labels, brochures, packaging, transportation and storage.
This standard applies to chemiluminescent immunoassay for the quantitative determination of the principles of human carbohydrate antigen CA50 reagent (box) [hereinafter referred to as
"CA50 reagent (kit)"]. Including microplates, tubes, magnetic particles, beads and plastic beads as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay
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
CA50 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
The skin 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 CA50 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.
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