Evaluation of the performance of a new automated HIV combination assay

- The aim of this study was to evaluate the performance of this new HIV combination assay.
- According to our knowledge, this is the first manuscript described the performance of this new essay.
- The results showed a good correlation between Architect HIV combo and this new LIAISON® XL murex HIV Ab/Ag HT assay. Sensitivity was 100% in known antibody positive [HIV-1 M and O, and HIV-2] samples. HIV p24 antigen detection was 100% in 90 primary HIV-1 infection samples. Specificity was 99.7%. Sensitivity was 100% (382/382) in known antibody positive samples. HIV p24 antigen detection was 100% in 90 primary HIV-1 infection samples. Specificity was 99.7%.

BackgroundMore and more countries test for HIV infection using combination assays that simultaneously detect p24 antigen and HIV antibodies.ObjectiveTo assess the performance of a new HIV combo assay: LIAISON® XL murex HIV Ab/Ag HT.Study designThe 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.ResultsThe 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 0.58 IU/mL and 9.93 pg/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.ConclusionThe 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.