title: Detection of HCV and HIV-1 antibody negative infections in Scottish and Northern Ireland blood donations by nucleic acid amplification testing.
abstract: OBJECTIVE
  To reduce the risk of transfusion-transmissible viruses entering the blood supply, the nucleic acid amplification testing (NAT) was implemented to screen Scottish and Northern Irish blood donations in minipools. After 5 years of NAT for hepatitis C virus (HCV) and 2 years for human immunodeficiency virus-1 (HIV-1), the yield of serologically negative, nucleic acid positive 'window donations' and cost-benefit of NAT is under review.
  
  
  METHODS
  When the Scottish National Blood Transfusion Service (SNBTS) implemented NAT in 1999, a fully automated 'black box' system was not available. Therefore, an 'in-house' assimilated NAT assay was developed, validated and implemented. The system is flexible and allows testing for additional viral markers to be introduced with relative ease.
  
  
  RESULTS
  The HCV and HIV NAT assays have 95% detection levels of 7.25 IU/ml and 39.8 IU/ml, respectively, as determined by probit analysis. One HCV (1 in 1.9 million) and one HIV (1 in 0.77 million) window donation have been detected in 5 and 2 years, respectively, of NAT.
  
  
  CONCLUSIONS
  The SNBTS NAT assays are robust and have performed consistently over the last 5 years. The design of the in-house system allowed HIV NAT to be added in 2003 at a relatively small additional cost per sample, although for both assays, the royalty fee far exceeds the cost of the test itself. Clearly NAT has a benefit in improving the safety of the blood supply although the risks of transfusion-transmitted viral infections, as reported in the Serious Hazards of Transfusion (SHOT) report, are extremely low. Also, in UK the yield of HCV antibody negative, NAT positive donations is far lower than predicted although the early detection of an HIV window period donation and the increase of HIV in the blood donor and general populations may provide a stronger case for HIV NAT. SUMMARY SENTENCE: The yield of HCV and HIV NAT in UK is significantly less than that anticipated from statistical models.
authors.affiliation: Scottish National Blood Transfusion Service, Transfusion Transmissible Infections Group, University of Edinburgh, Edinburgh, Scotland, UK. ljarvis@ed.ac.uk
authors.forename: L M
authors.initials: LM
authors.lastname: Jarvis
authors.forename: B C
authors.initials: BC
authors.lastname: Dow
authors.forename: A
authors.initials: A
authors.lastname: Cleland
authors.forename: F
authors.initials: F
authors.lastname: Davidson
authors.forename: C
authors.initials: C
authors.lastname: Lycett
authors.forename: K
authors.initials: K
authors.lastname: Morris
authors.forename: B
authors.initials: B
authors.lastname: Webb
authors.forename: A
authors.initials: A
authors.lastname: Jordan
authors.forename: J
authors.initials: J
authors.lastname: Petrik
mesh_terms: D000328:Adult; D001782:Blood Donors; D001803:Blood Transfusion / Q000191:economics / Q000379:methods / Q000592:standards*; D003362:Cost-Benefit Analysis; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D018023:HIV Seronegativity; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D007494:Ireland; D008297:Male; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques / Q000191:economics / Q000592:standards* / Q000706:statistics & numerical data; D012606:Scotland; D012680:Sensitivity and Specificity; D012698:Serologic Tests