YY/T 1262-2015Neuron specific enolase quantitative labelling immunoassay kit (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

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