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YY/T 1240-2023D-dimer testing kit (immunoturbidimetric method) (English PDF)

D-二聚体测定试剂盒（免疫比浊法）

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

July 15, 2023

Scope

YY/T 1240-2023 is the English-translated version of D-二聚体测定试剂盒（免疫比浊法）.

YY/T 1240 is the Chinese standard for D-dimer test kits using the immunoturbidimetric method.

D-dimer is the test that rules out venous thromboembolism: a negative result in a patient at low clinical probability is enough to avoid imaging, which makes the sensitivity of the assay near the cut-off a matter of missed pulmonary embolism rather than of laboratory precision.

The document sets out how such a kit is classified, the technical requirements it has to meet, the test methods that demonstrate them, and the labelling, packaging and storage rules.

D-dimer is also one of the least standardised analytes between manufacturers, with units and cut-offs that do not transfer, which is part of why a national standard exists.

For a diagnostics manufacturer, this is the text a Chinese registration is assessed against.

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Document preview — YY/T 1240-2023

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 13 January 2023 by the National Medical Products Administration and takes effect on 15 July 2023.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

1 Scope

YY/T 1240 is the Chinese standard for D-dimer test kits using the immunoturbidimetric method. D-dimer is the test that rules out venous thromboembolism: a negative result in a patient at low clinical probability is enough to avoid imaging, which makes the sensitivity of the assay near the cut-off a matter of missed pulmonary embolism rather than of laboratory precision. The document sets out how such a kit is classified, the technical requirements it has to meet, the test methods that demonstrate them, and the labelling, packaging and storage rules. D-dimer is also one of the least standardised analytes between manufacturers, with units and cut-offs that do not transfer, which is part of why a national standard exists. For a diagnostics manufacturer, this is the text a Chinese registration is assessed against.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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