title: Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings.
abstract: BACKGROUND
  Emergency whole blood transfusion is a lifesaving procedure employed on modern battlefields. Rapid device tests (RDTs) are frequently used to mitigate transfusion-transmitted infection risks.
  
  
  METHODS
  A limited evaluation of the RDT formerly used on battlefields was performed using 50 donor plasma samples and commercially available panels. Five hepatitis C virus (HCV) RDTs with sufficient stated sensitivity and thermostability were assessed using 335 HCV-positive and 339 HCV-negative donor plasma samples, 54 seroconversion panel plasma samples, and 84 HCV-positive and 84 HCV-negative spiked whole blood under normal, hot, and cold storage conditions and normal and hot test conditions, plus an ease-of-use survey.
  
  
  RESULTS
  BioRapid HCV test sensitivity on donor plasma was 84% (95% confidence interval [CI], 70.9%-92.8%). Using all positive plasma samples, OraQuick HCV sensitivity exceeded all comparators (99.4%, 95% CI, 98.0%-99.9%, p<0.05). Specificity was consistently high, led by OraQuick HCV at 99.7% (95% CI, 98.6%-100%), statistically superior only to Axiom HCV (p<0.05). Using seroconversion panels, only OraQuick HCV showed equivalent or earlier HCV detection compared to the gold standard. Using spiked whole blood, specificity was consistently high, and sensitivity ranged significantly from 34.5% (95% CI, 25.0%-45.1%) for CORE HCV to 98.8% (95% CI, 94.3%-99.9%) for OraQuick HCV. All comparator RDTs were significantly less sensitive than OraQuick HCV at one or more stress condition.
  
  
  CONCLUSIONS
  This HCV RDT comparison identified significant sensitivity differences, particularly using whole blood under extreme storage and testing conditions. These data support OraQuick HCV superiority and illustrate the value of RDT evaluation under simulated field conditions.
authors: Walter Reed Army Institute of Research, Silver Spring, Maryland, USA. roconnell@hivresearch.org
authors: Robert J
authors: RJ
authors: O'Connell
authors: Robert G
authors: RG
authors: Gates
authors: Christian T
authors: CT
authors: Bautista
authors: Michelle
authors: M
authors: Imbach
authors: John C
authors: JC
authors: Eggleston
authors: Stephen G
authors: SG
authors: Beardsley
authors: Mark M
authors: MM
authors: Manak
authors: Richard
authors: R
authors: Gonzales
authors: Francisco J
authors: FJ
authors: Rentas
authors: Victor W
authors: VW
authors: Macdonald
authors: Lisa J
authors: LJ
authors: Cardo
authors: David T
authors: DT
authors: Reiber
authors: Susan L
authors: SL
authors: Stramer
authors: Nelson L
authors: NL
authors: Michael
authors: Sheila A
authors: SA
authors: Peel
mesh_terms: D000465:Algorithms; D001782:Blood Donors / Q000706:statistics & numerical data; D001793:Blood Preservation / Q000379:methods; D058731:Blood Safety; D019411:Clinical Laboratory Techniques / Q000295:instrumentation / Q000379:methods; D046148:Donor Selection / Q000379:methods*; D004526:Efficiency; D004632:Emergency Medical Services / Q000379:methods / Q000592:standards; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis; D018937:Hepatitis C Antibodies / Q000032:analysis / Q000097:blood*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic