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YY/T 1254-2015: High density lipoprotein (LDL) cholesterol assay kit
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1254-2015	English	189	Add to Cart	3 days [Need to translate]	High density lipoprotein (LDL) cholesterol assay kit

YY/T 1254-2015: High density lipoprotein (LDL) cholesterol assay kit

---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.
High density lipoprotein (LDL) cholesterol assay kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards High-density lipoprotein cholesterol assay reagent (kit) Highdensitylipoprotein (HDL) cholesterolassaykit Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

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. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. 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, Shanghai Fuxing Changzheng Medical Science Co., Ltd., Beijing nine strong biotech stocks Parts Co., InTec (Xiamen) Technology Co., Ltd. Jiang Xi Tekang. The main drafters of this standard. Bi Chunlei, Wu Jie, Chen Yang, Wang Jun, Du Jiao, Xiao Yan. High-density lipoprotein cholesterol assay reagent (kit)

1 Scope

The standard provides a high-density lipoprotein cholesterol assay reagent (kit) requirements, test methods, marking, labeling and instructions for use, package Loading, transportation and storage. This standard applies to the use of the direct method in human serum or plasma high-density lipoprotein cholesterol quantitative detection reagent (box), the base Spectrophotometry in principle, including manual reagents and on the semi-automatic biochemical analyzer used.

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. Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements

3 Requirements

3.1 Appearance 3.1.1 Kit components should be complete, complete, no liquid leakage. 3.1.2 Packaging label text symbols should be clear. 3.2 PACKING Not less than the indicated value. 3.3 reagent blank absorbance When adding reagent blank sample test, the absorbance of the reagent blank should be < 0.05. 3.4 Sensitivity Analysis Determination of 1.00mmol/L sample, the two end-point method absorbance difference (ΔA) should be > 0.04; two-point rate method absorbance difference (ΔA/min) should be > 0.01. 3.5 Linear Reagent (box) linear in [0.20,2.50] mmol/L range. a) The linear correlation coefficient (r) shall be not less than 0.995; b) within [0.20,2.50] mmol/L range, linearity deviation should not exceed ± 0.10mmol/L or no more than ± 10%. 3.6 Precision 3.6.1 Repeatability Repeat the test (0.80 ± 0.20) mmol/L and (1.50 ± 0.50) mmol sample/L, and the results of the coefficient of variation (CV) should not ...