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YY/T 1450-2016: Apolipoprotein A-I test reagent
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1450-2016 | English | 179 |
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Apolipoprotein A-I test reagent
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YY/T 1450-2016
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Basic data | Standard ID | YY/T 1450-2016 (YY/T1450-2016) | | Description (Translated English) | Apolipoprotein A-I test reagent | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,981 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | YY/T 0466.1 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements, test methods, labeling, labeling and instructions for use of the apolipoprotein A-I reagent (kit), packaging, transport and storage requirements. This standard is applicable to reagents (cartridges) for the quantitative detection of apolipoprotein A-I in human serum or plasma using the immunoturbidimetry (transmission method), including reagents used in manual and semi-automatic, fully automated biochemical analyzers. | YY/T 1450-2016: Apolipoprotein A-I test reagent---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.
Apolipoprotein AI test reagent
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Apolipoprotein AI Assay Reagent (Box)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Device Testing Institute, Beckman Coulter Trading (China) Co., Ltd., Shanghai Fuxing Long March Medical
Science Co., Ltd., the British Branch new (Xiamen) Technology Co., Ltd., Beijing Leadman Biochemical Co., Ltd.
The main drafters of this standard. Bi Chunlei, Liu Qiuyue, Wu Jie, Du Haiou, Du Jiao, Hao Zhenhua.
Apolipoprotein AI Assay Reagent (Box)
1 Scope
This standard specifies the requirements, test methods, labeling, labeling and instructions for use of apolipoprotein AI assays (cartons), packaging, transport
And storage requirements.
This standard is applicable to the use of immunoturbidimetry (transmission method) on human serum or plasma apolipoprotein AI in the quantitative detection of reagents
(Box), including manual and semi-automatic, automatic biochemical analyzer used on the reagent.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 request
3.1 appearance
Should specify the normal appearance requirements.
3.2 Capacity
Should not be less than the marked value.
3.3 Reagent Blank Absorbance
Should specify the reagent blank absorbance requirements.
3.4 Analysis of sensitivity
Test the concentration of 1.00g/L of the sample, the absorbance difference (ΔA) should be not less than 0.10.
Note. The test wavelength is 340nm, other test wavelengths or through the sample pre-dilution test can be adjusted accordingly.
3.5 Linearity
The linear range of reagent (box) should be covered [0.40,2.20] g/L.
a) The linear correlation coefficient (r) should be not less than 0.990;
b) [0.40,2.20] g/L interval, the linear deviation should not exceed ± 10%.
3.6 precision
3.6.1 Repeatability
Repeated test (1.00 ± 0.50) g/L of human serum or control substance, the results of the coefficient of variation CV (%) should not be greater than 3%.
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