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YY/T 1792-2021Fluorescence immunochromatography analyzer (English PDF)

荧光免疫层析分析仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

March 1, 2022

Scope

YY/T 1792-2021 is the English-translated version of 荧光免疫层析分析仪.

YY/T 1792-2021 is the Chinese pharmaceutical industry standard for the fluorescence immunochromatography analyser, the reader used with a fluorescently labelled lateral flow card to measure an analyte in a human sample.

It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the stability and linearity of the fluorescence measurement, the repeatability and the accuracy of the quantification, the carry-over, the warm-up and the behaviour of the instrument with its reagent cards. Issued on 6 September 2021, it has applied since 1 March 2022.

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Document preview — YY/T 1792-2021

National Standard of the People's Republic of China

Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and Definitions

Foreword

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

1 Scope

This standard specifies the requirements, test methods, labeling and instructions for use, packaging, transportation and storage of fluorescence immunochromatography analyzers.

This standard applies to fluorescence immunochromatography analyzers (hereinafter referred to as analyzers) for quantitative analysis of analytes in human samples. analyze The instrument is used in conjunction with the immunochromatographic reagent card labeled with fluorescent substances, and by measuring the fluorescence intensity of the bands in the reaction zone, it can be used in human samples to be tested. Quantitative analysis.

This standard does not apply to instruments for the detection of immunochromatographic reagent cards using colloidal gold labeling or other labeling methods.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 Graphical signs of packaging, storage and transportation

GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Laboratory use for analysis and other purposes Particular requirements for automatic and semi-automatic equipment

GB/T 14710 Medical Electrical Environment Requirements and Test Methods

GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB/T 18268.26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26: Special Requirements In vitro diagnostic (IVD) medical devices

GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 3: In vitro diagnostic instruments for professional use

YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101.In Vitro Diagnostic (IVD) Medical Equipment specific requirements

3 Terms and Definitions

3.1 Immunochromatographic analysis is a membrane analysis method that combines antigen-antibody specific immune response and chromatography techniques. Fluorescent immune layer

Analytical analysis uses fluorescent substances as tracers to label antigens or antibodies for immunoreaction with the analyte to measure the fluorescence intensity of the final product from The analytical techniques to obtain the concentration of the analyte, the fluorescent markers mainly include fluorescein, quantum dots, up-conversion nanoparticles and so on.

3.2 Fluorescence immunochromatography analyzer

Used in conjunction with the fluorescence immunochromatography analysis reagent card, by measuring the fluorescence intensity of the band in the reaction zone, the detection of the analyte in the human sample can be achieved. An instrument for qualitative or quantitative analysis.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4793.9

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