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Division 2 DEFINITIONS AND TERMSF1

United Kingdom

Original text. Later amendments are not shown.

  1. (Diagnostic) sensitivity
  2. True positive
  3. False negative
  4. (Diagnostic) specificity
  5. False positive
  6. True negative
  7. Analytical sensitivity
  8. Analytical specificity
  9. Nucleic acid amplification techniques (NAT)
  10. Rapid test
  11. Robustness
  12. Whole system failure rate
  13. Confirmation assay
  14. Virus typing assay
  15. Sero-conversion HIV samples
  16. Early sero-conversion HIV samples

Annotations

Textual amendments

F1

Substituted by Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC).