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YY/T 1584-2018: Retinol binding protein testing kit(immune turbidity method)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1584-2018	English	159	Add to Cart	3 days [Need to translate]	Retinol binding protein testing kit(immune turbidity method)

YY/T 1584-2018: Retinol binding protein testing kit(immune turbidity method)

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Retinol binding protein testing kit(immune turbidity method) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Retinol 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, Ningbo Meikang Biotechnology Co., Ltd., Shanghai Kehua Biological Engineering Unit Co., Ltd., Beijing Lidman Biochemical Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd. The main drafters of this standard. Li Zheng, Zou Bingde, Xiao Lusheng, Ren Yikun, Cai Huaya. Retinol binding protein assay kit (immunoturbidimetry)

1 Scope

This standard specifies the requirements, test methods, labels, labels and instructions for use of the retinol binding protein assay kit (immunoturbidimetry). Book, packaging, transportation and storage. This standard applies to immunoturbidimetric methods for spectrophotometers or biochemical analyzers (eg immunoturbidimetry, latex-enhanced immunoturbidimetry) Etc.) Determination of retinol-binding protein assay kit (hereinafter referred to as "RBP kit") in serum samples and retinol-conjugated eggs in urine samples White assay kit (hereinafter referred to as "URBP kit"). This standard does not apply to the evaluation of retinol binding protein calibrators and controls.

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 Should meet the requirements of the manufacturer. 3.4 Analytical sensitivity 3.4.1 RBP kit When testing a sample with a concentration of 50.0 mg/L, the absorbance difference (ΔA) should be ≥0.05. 3.4.2 URBP kit When testing a sample with a concentration of 1.0 mg/L, the absorbance difference (ΔA) should be ≥0.01. 3.5 Accuracy Accuracy should meet one of the following requirements. ...