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YY/T 1590-2018: Heart-type fatty acid-binding protein testing kit(immune turbidity method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1590-2018 | English | 139 |
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Heart-type fatty acid-binding protein testing kit(immune turbidity method)
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YY/T 1590-2018
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Basic data | Standard ID | YY/T 1590-2018 (YY/T1590-2018) | | Description (Translated English) | Heart-type fatty acid-binding protein testing kit(immune turbidity method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 7,715 | | Date of Issue | 2018-02-24 | | Date of Implementation | 2019-03-01 | | Quoted Standard | GB/T 191; GB/T 29791.2 | | Regulation (derived from) | China Food and Drug Administration announced No. 27 of 2018 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements for heart-type fatty acid-binding protein assay kits (immunoturbidimetry), test methods and labeling, labeling and instruction manuals, packaging, transportation, and storage. This standard applies to spectrophotometer or biochemical analyzer using immunoturbidimetric method (such as latex-enhanced immunoturbidimetry, etc.) Determination of serum samples of heart-type fatty acid binding protein kit (immune turbidimetric method), referred to as "kit" . | YY/T 1590-2018: Heart-type fatty acid-binding protein testing kit(immune turbidity method)---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.
Heart-type fatty acid-binding protein testing kit(immune turbidity method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Cardiac fatty acid binding protein assay kit
Published on.2018-02-24
2019-03-01 implementation
State Food and Drug Administration issued
Foreword
This standard was 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 issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This standard was drafted. Beijing Medical Device Inspection Institute, Beijing Wantai Derui Diagnostic Technology Co., Ltd., Baiding Biological Engineering (Beijing)
Co., Ltd., Zhongsheng North Control Biotechnology Co., Ltd.
The main drafters of this standard. Li Zheng, Li Xue, Shi Fuqin, Yue Caiqin.
Cardiac fatty acid binding protein assay kit
(immunoturbidimetry)
1 Scope
This standard specifies the requirements, test methods, identification, labeling and use of the heart-shaped fatty acid binding protein assay kit (Immuno Turbidimetry).
Instructions, packaging, transportation and storage.
This standard is applicable to the measurement of serum sample by immunoturbidimetry (such as latex enhanced immunoturbidimetry) by spectrophotometer or biochemical analyzer.
A kit for a fatty acid-binding protein (immunotactic method), hereinafter referred to as a "kit".
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents
3 requirements
3.1 Appearance
The components of the kit should be complete and complete, and the liquid should be free of leakage.
3.2 Loading
The liquid content in the kit should be no less than the indicated value.
3.3 Reagent blank absorbance
The reagent blank absorbance should be less than or equal to 1.5.
3.4 Analytical sensitivity
When the test sample concentration is 5.0 μg/L, the absorbance difference (ΔA) ≥ 0.01.
3.5 Accuracy
Accuracy should meet one of the following requirements.
a) relative deviation. the relative deviation should not exceed ±15%;
b) Comparison test. the sample concentration used should cover (2.5, 120.0) μg/L interval; correlation coefficient r ≥ 0.975; (2.5, 15.0] μg/L
Within the interval, the absolute deviation should be in the range of ±2.3μg/L; in the interval of (15.0,120.0)μg/L, the relative deviation should be
Within the range of ±15.0%.
3.6 linear
Manufacturers should provide a linear interval for the heart-type fatty acid binding protein kit that should cover the (2.5, 120.0) μg/L interval.
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