title: Comparison of two automated nucleic acid testing systems for simultaneous detection of human immunodeficiency virus and hepatitis C virus RNA and hepatitis B virus DNA.
abstract: BACKGROUND
  Recently developed nucleic acid testing (NAT) assays incorporating simultaneous detection of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) have made HBV NAT screening more feasible for blood services. This study compared the performance of two "multiplex" NAT assays and their automated testing platforms.
  
  
  METHODS
  The HBV NAT yield rate was estimated by testing 10,397 Hong Kong (HK) donor samples concurrently on the PROCLEIX ULTRIO (Ultrio) assay as individual donor samples with the TIGRIS and on the cobas TaqScreen multiplex (cobas MPX) test in pools of 6 with the cobas s 201. Analytical sensitivity was assessed by probit analysis of diluted international standards and operational performance was compared.
  
  
  RESULTS
  Each system detected two different HBV NAT yield samples for a combined rate of 0.04 percent. One additional sample was reactive on the cobas MPX test but remained unresolved. The 95 percent detection limits for HIV-1, HBV, and HCV were 42.2, 12.2, and 2.0 IU per mL, respectively, for Ultrio and 50.5, 8.4, and 6.0 IU per mL for the cobas MPX. The invalid test and failed run rates were 0.05 and 2.92 percent, respectively, for the TIGRIS and 2.39 and 5.53 percent for the cobas s 201.
  
  
  CONCLUSIONS
  Clinical sensitivity for HBV in HK blood donors was equivalent, as was the analytical sensitivity for HIV-1 and HBV; however, the Ultrio assay had a higher analytical sensitivity for HCV. Despite a shorter downtime and mean time of repair for the cobas s 201, the TIGRIS demonstrated better overall operational performance.
authors: Australian Red Cross Blood Service-Enterprise, 97 Great Eastern Highway, Rivervale, Western Australia 6103. amargaritis@arcbs.redcross.org.au
authors: Angelo R
authors: AR
authors: Margaritis
authors: Stewart M
authors: SM
authors: Brown
authors: Clive R
authors: CR
authors: Seed
authors: Philip
authors: P
authors: Kiely
authors: Bruno
authors: B
authors: D'Agostino
authors: Anthony J
authors: AJ
authors: Keller
mesh_terms: D001315:Australia; D001331:Automation; D001803:Blood Transfusion / Q000592:standards*; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D006678:HIV / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D006723:Hong Kong; D006801:Humans; D012367:RNA, Viral / Q000097:blood*
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral