Evaluation of the performance of a new automated HIV combination assay

Abstract

Background: More and more countries test for HIV infection using combination assays that simultaneously detect p24 antigen and HIV antibodies.

Objective: To assess the performance of a new HIV combo assay: LIAISON^® XL murex HIV Ab/Ag HT.

Study design: The assays were examined with a total of 3090 samples that included 769 selected HIV antibody-negative samples, 1849 unselected HIV samples, 15 HIV-1 p24 Ag reference samples, 90 primary HIV-1 infection (PHI) samples, 167 HIV-1 antibody-positive samples (well characterized of groups M and O), 95 HIV-1 antibody-positive samples and 105 HIV-2 antibody-positive samples.

Results: The specificity of the LIAISON^® XL murex HIV Ab/Ag HT was 99.7%. The analytical sensitivity of Ag p24 of the LIAISON^® XL murex HIV Ab/Ag HT was 0.58IU/mL and 9.93pg/mL when using WHO and French national standards, respectively. All screened HIV subtypes was identified by this assay. Also, 90 PHI specimens were detected by this screening assay.

Conclusion: The sensitivity and specificity of the LIAISON^® XL murex HIV Ab/Ag HT assay are high. Hence the assay offers automated high-throughput screening with ability to detect primary infection.

Keywords: HIV; Immunoassay; Serodiagnostic.