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YY/T 1262-2015: Neuron specific enolase quantitative labelling immunoassay kit
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1262-2015	English	189	Add to Cart	3 days [Need to translate]	Neuron specific enolase quantitative labelling immunoassay kit

YY/T 1262-2015: Neuron specific enolase quantitative labelling immunoassay 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.
Neuron specific enolase quantitative labelling immunoassay kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Neuron-specific enolase quantitative Labeled Immunoassays Assay Kits 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. Release mechanism of the present document does not assume responsibility for the identification of 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. The standard by the China Research Institute of Food and Drug test drafted. The main drafters of this standard. Liu Yan, Sun Nan, Yu Ting, Wang Yumei, noble first. Neuron-specific enolase quantitative Labeled Immunoassays Assay Kits

1 Scope

This standard defines the quality of neuron-specific enolase quantitative marker immunoassay kit requirements, test methods, marking, labeling And instructions for use and packaging, transportation and storage. This standard applies to be neuron-specific enolase (hereinafter referred to as NSE) quantitative determination of labeled immunoassay kit (hereinafter Acronym kit). Include enzyme labels, chemiluminescent labels, time resolved fluorescent labels labeling method as capture antibodies to microtiter plates, tubes, Magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative determination of NSE immunoassay kits.

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. GB/T 191 Packaging - Pictorial signs Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements Category 3 The kit can be divided according to different labeling methods ELISA, chemiluminescence, and other time-resolved immunofluorescence assay kit, according to Solid support can be divided into microtiter plate, pipe, magnetic particles, beads and plastic beads as the carrier of the kit; based on the operation of different Method can be divided into manual and automatic operation of law instrument kit.

4 Requirements

4.1 Appearance Manufacturers should be based on the characteristics of the packaging of their products provide adequate appearance requirements. Usually the kit components should be composed of characters; inside and outside Packaging, labeling and other requirements clear. 4.2 blank Limit Blank limit shall not be higher than 0.50μg/L. 4.3 Linear Within a given manufacturer's range of linear correlation coefficient (r) shall not be less than 0.9900. Note. The lower limit of the linear range of not higher than 0.50μg/L, the upper limit of the linear range of not less than 200.00μg/L. 4.4 Accuracy Accuracy should meet one of the requirements are as follows. a) as samples for testing by the reference material, the measurement results of the relative deviation should be within ± 15.0% range; ...