title: Evaluation of a rapid on-site anti-HCV test as a screening tool for hepatitis C virus infection.
abstract: BACKGROUND
  In settings such as needle-stick injuries or intravenous drug abuse, immediate knowledge of the anti-hepatitis C virus (HCV) serostatus instead of waiting for the results of a laboratory-based test can be important to guide further medical procedures and appropriate hygienic advises. Thus, a rapid on-site anti-HCV test was evaluated in daily clinical routine and compared with a laboratory-based certified assay.
  
  
  METHODS
  Ten microliters of serum or EDTA whole blood was analyzed using a chromatographic immunoassay (Toyo anti-HCV test). Results were available on-site 5-15 min after sample centrifugation. The Architect anti-HCV test served as a reference method.
  
  
  RESULTS
  Sera of 189 patients were analyzed (without HCV infection: n=105; HCV infection: n=84). The assay was evaluable in 185 cases (98%). The sensitivity and specificity were 99 and 88%, respectively. With EDTA whole blood, the test was evaluable in 47/52 samples (90%). Forty-six of 47 evaluable EDTA tests were concordant with serum results. The one HCV patient with an unevaluable serum test was diagnosed correctly with the EDTA sample.
  
  
  CONCLUSIONS
  The rapid chromatographic anti-HCV immunoassay has limited specificity, which impairs clinical practicability. A positive result warrants re-evaluation with a certified serologic assay.
authors.affiliation: Department of Internal Medicine, Dermatology and Neurology, Clinic of Gastroenterology and Rheumatology, Section of Hepatology, University of Leipzig, Liebigstr. 20, 04103 Leipzig, Germany.
authors.forename: Juliane
authors.initials: J
authors.lastname: Kant
authors.forename: Bernd
authors.initials: B
authors.lastname: Möller
authors.forename: Renate
authors.initials: R
authors.lastname: Heyne
authors.forename: Adam
authors.initials: A
authors.lastname: Herber
authors.forename: Stephan
authors.initials: S
authors.lastname: Böhm
authors.forename: Melanie
authors.initials: M
authors.lastname: Maier
authors.forename: Uwe G
authors.initials: UG
authors.lastname: Liebert
authors.forename: Joachim
authors.initials: J
authors.lastname: Mössner
authors.forename: Thomas
authors.initials: T
authors.lastname: Berg
authors.forename: Johannes
authors.initials: J
authors.lastname: Wiegand
mesh_terms: D005189:False Positive Reactions; D005260:Female; D016174:Hepacivirus / Q000276:immunology; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D010865:Pilot Projects; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity
chemical_list: D018937:Hepatitis C Antibodies