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YY/T 1722-2020: Prealbumin testing kit (immune turbidity method)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1722-2020	English	189	Add to Cart	3 days [Need to translate]	Prealbumin testing kit (immune turbidity method)

YY/T 1722-2020: Prealbumin 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.
Prealbumin testing kit (immune turbidity method) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Prealbumin determination kit (immunoturbidimetric method) 2020-06-30 released 2021-12-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. Publication of this document The agency is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this standard. Beijing Jiuqiang Biotechnology Co., Ltd., Beijing Medical Device Testing Institute, Shanghai Clinical Testing Center, Desay Diagnostic System (Shanghai) Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Beijing Leadman Biochemical Co., Ltd., Intech Innovation (Xiamen) Technology Co., Ltd. The main drafters of this standard. Chen Yang, Li Zheng, Tang Liping, Zou Yanfang, Huang Bin, Ren Yikun, Wang Lixia. Prealbumin determination kit (immunoturbidimetric method)

1 Scope

This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of the prealbumin determination kit (immunoturbidimetric method). This standard applies to kits for quantitative detection of prealbumin in human serum or plasma by immunoturbidimetric method (hereinafter referred to as reagents). Box), including the reagents used on manual and semi-automatic and fully automatic biochemical analyzers. This standard does not apply to kits for the determination of prealbumin by dry chemical methods.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance The appearance should meet the following requirements. a) Each component of the kit should be complete, complete and free of leakage; b) The label should be clear and easy to identify. 3.2 Net content The net content of liquid reagents in the kit should not be less than the label value. 3.3 Absorbance of reagent blank When a blank sample is added to the reagent test, the reagent blank absorbance measured at the measurement wavelength (optical path 1cm) specified in the kit instructions The degree should not be greater than 0.3. 3.4 Analysis sensitivity When measuring 150mg/L sample, the difference in absorbance should not be less than 0.025. 3.5 Linear The manufacturer shall specify the linear interval of the kit, at least covering the interval of [30,550] mg/L, and meet the following requirements. a) The linear correlation coefficient (r) should not be less than 0.990; b) In the interval of [30,200]mg/L, the linear absolute deviation should not exceed ±20mg/L; in the interval of (200,550)mg/L, the linear The relative deviation should not exceed ±10%. ...