Skip to : [Content] [Navigation]
 

IVD Technology

 
 
Email article link Print article

Originally Published IVD Technology June 2003

IVD DIRECTIVE

CTS for the performance evaluation of serological assays

Article 5 of the IVD Directive called for the development of common technical specifications (CTS) to be used in evaluating the performance of certain high-risk IVDs (specified in Annex II, List A, of the directive). Following are the key elements of the CTS for serological assays, which was adopted by the European Commission in 2001 and published in the Official Journal of the European Communities in 2002. 10

  • All candidate IVDs used to detect virus infections in the blood supply are subject to the same requirements for sensitivity and specificity.
  • All candidate IVDs must be compared with a second device that uses a different antigen or test principle for detection.
  • Discrepant results must be investigated and accounted for. Subsequent comparative testing of the candidate IVD should not yield discrepant results.
  • Evaluations should be performed on samples or panels that are equivalent to those recognized and approved by the national competent authority.
  • Positive specimens must represent all disease stages and subtypes of the pathogen to be detected by the candidate IVD.
  • All positive samples must test positive.
  • Negative "control" samples should be taken from populations that are demographically representative of the European population.
  • Diagnostic sensitivity should be equivalent to the nationally recognized state of the art.
  • Test specificity should measure at least 99.5% in asymptomatic individuals (e.g., blood donors).
  • The candidate IVD should be used to perform consecutive tests on randomly selected blood donor samples from at least two different donation centers.
  • Factors that could potentially interfere with the status of specimens (e.g., related infections, pregnancy, multipara, rheumatoid factors, etc.) should be considered; any interference with test results should be documented.
  • Serum/plasma equivalency should be investigated.
  • A risk analysis of low-positive specimens should be conducted.
  • The CTS requirements for sensitivity and specificity must also be applied to other body fluids used as specimens subject to screening by the candidate IVD.

    Copyright ©2003 IVD Technology