title: Performance of Liaison XL automated immunoassay platform for blood-borne infection screening on hepatitis B, hepatitis C, HIV 1/2, HTLV 1/2 and Treponema pallidum serological markers.
abstract: OBJECTIVE
  Aim of the study was to evaluate performance of a new fully automated platform, DiaSorin-LIAISON® XL (DiaSorin S.p.A, Vercelli, Italy), in blood donor screening, specifically for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti-HBc), hepatitis C antibodies (anti-HCV), HIV p24 antigen, HIV antibodies, human T-lymphotropic virus types 1 and 2 (HTLV-1/2) and Treponema pallidum antibodies.
  
  
  BACKGROUND
  In screening for such viral and bacteriological blood-borne infections, sensitivity and specificity are of utmost importance.
  
  
  METHODS
  Sensitivity was evaluated using selected panels of samples previously analysed on the Abbott Architect immunoanalyser (Abbott Laboratories, Abbott Park, IL, USA)--the gold standard for this evaluation. These samples were confirmed positive for HBsAg, anti-HBc, anti-HCV, HIV Ag/Ab, anti-HTLV-1/2 and antibodies to T. pallidum, respectively. Specificity analysis was assessed by analysing blood donor samples previously run on the Architect platform and found non-reactive for each marker. A total of 1·100 donor samples (both new and regular donors) were tested. Previously, non-specific reactive samples were also run for every tested marker, as well as samples with autoimmune antibodies and antibodies to other infections.
  
  
  RESULTS
  Three hundred seventy-eight samples positive for the tested markers (HBsAg n = 51, anti-HBc n = 52, anti-HCV n = 75, anti-Treponema n = 55, anti-HIV-1 n = 79, anti-HIV-2 n = 25, anti-HIV 1/2 n = 3, anti-HTLV-1 n = 28 anti-HTLV-2 n = 10) were tested and found positive, suggesting a high sensitivity. A number of 342-1100 negative blood donors (depending on marker) have been tested, with very good specificity for the markers tested, ranging between 99·5 and 100%, respectively.
  
  
  CONCLUSIONS
  The LIAISON® XL platform demonstrated very high sensitivity for the markers tested and the specificity necessary to fulfil the stringent requirements for blood donor screening.
authors.affiliation: Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors.forename: K
authors.initials: K
authors.lastname: Malm
authors.affiliation: Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Kragsbjerg
authors.affiliation: Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors.forename: S
authors.initials: S
authors.lastname: Andersson
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood*; D001331:Automation; D001782:Blood Donors; D017848:Blood-Borne Pathogens; D003429:Cross Reactions; D005189:False Positive Reactions; D015483:HIV Antibodies / Q000097:blood; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D016174:Hepacivirus / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000097:blood; D015368:Human T-lymphotropic virus 1 / Q000276:immunology; D015367:Human T-lymphotropic virus 2 / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation*; D008163:Luminescent Measurements / Q000295:instrumentation*; D008403:Mass Screening / Q000295:instrumentation*; D012680:Sensitivity and Specificity; D013588:Syphilis Serodiagnosis / Q000295:instrumentation*; D014210:Treponema pallidum / Q000276:immunology; D014766:Viremia / Q000097:blood* / Q000175:diagnosis
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015483:HIV Antibodies; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D018937:Hepatitis C Antibodies
keywords: Liaison XL; blood-borne infections; immunoassay; sensitivity; specificity