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

OBJECTIVES:

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: K Malm, E Kragsbjerg, S Andersson
• Journal: Transfusion medicine (Oxford, England) (Transfus Med) Vol. 25 Issue 2 Pg. 101-5 (Apr 2015) ISSN: 1365-3148 [Electronic] England
• PMID: 25779614 (Publication Type: Comparative Study, Evaluation Study, Journal Article)
• Copyright: © 2015 British Blood Transfusion Society.

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• HIV Antibodies
• Hepatitis B Antibodies
• Hepatitis B Surface Antigens
• Hepatitis C Antibodies

Topics

• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Automation
• Blood Donors
• Blood-Borne Pathogens
• Cross Reactions
• False Positive Reactions
• HIV Antibodies (blood)
• HIV-1 (immunology)
• HIV-2 (immunology)
• Hepacivirus (immunology)
• Hepatitis B Antibodies (blood)
• Hepatitis B Surface Antigens (blood)
• Hepatitis B virus (immunology)
• Hepatitis C Antibodies (blood)
• Human T-lymphotropic virus 1 (immunology)
• Human T-lymphotropic virus 2 (immunology)
• Humans
• Immunoassay (instrumentation)
• Luminescent Measurements (instrumentation)
• Mass Screening (instrumentation)
• Sensitivity and Specificity
• Syphilis Serodiagnosis (instrumentation)
• Treponema pallidum (immunology)
• Viremia (blood, diagnosis)