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.
Document preview — YY/T 1240-2023
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
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
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
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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YY/T 1240-2023
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