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YY/T 1605-2018: Hemoglobin Alc testing kit(latex immunoturbidimetric method)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1605-2018	English	139	Add to Cart	3 days [Need to translate]	Hemoglobin Alc testing kit(latex immunoturbidimetric method)

YY/T 1605-2018: Hemoglobin Alc testing kit(latex immunoturbidimetric method)

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Hemoglobin Alc testing kit(latex immunoturbidimetric method) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Glycated hemoglobin assay kit (latex immunoturbidimetry) 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, Zhongsheng Beikong Biotechnology Co., Ltd., Changchun Dirui Medical Technology Co., Ltd. Co., Ltd., Yingke Xinchuang (Xiamen) Technology Co., Ltd. The main drafters of this standard. Song Wei, Jiang Lin, Liu Chunping, Wang Lixia. Glycated hemoglobin assay kit (latex immunoturbidimetry)

1 Scope

This standard specifies the requirements, test methods, identification, labeling and use of the glycated hemoglobin assay kit (latex immunoturbidimetry). Requirements for documentation, packaging, transportation and storage. This standard is applicable to the kit for quantitative detection of glycated hemoglobin in human whole blood by latex immunoturbidimetry (hereinafter referred to as. Kits, including kits for use on semi-automatic, fully automated biochemical analyzers, immunoassays.

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 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 amount of liquid reagent should be no less than the indicated value. 3.3 Reagent blank absorbance When a blank sample is used as a sample to be added to a reagent test, the reagent blank absorbance should be in accordance with the manufacturer’s claim at the dominant wavelength. Claim. 3.4 Analytical sensitivity The analytical sensitivity should be in accordance with the requirements stated by the manufacturer. 3.5 linear The reagent linearity is in the range of [3.8%, 14.0%] (NGSP units). a) the linear correlation coefficient (r) should be not less than 0.990; b) Linear deviation. In the interval of [3.8%, 7.0%] (NGSP unit), the linear absolute deviation should not exceed ±0.5% (NGSP unit). In the (7.0%, 14.0%) (NGSP unit) interval, the linear relative deviation should not exceed ± 7%. 3.6 precision 3.6.1 Repeatability The samples with high and low levels of two different concentrations are tested, and the repeatability (coefficient of variation, CV) of the results obtained should be no more than 3%. ...