Performance comparison of the 4th generation Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA on the EVOLIS™ automated system versus Abbott ARCHITECT HIV Ag/Ab Combo, Ortho Anti-HIV 1+2 EIA on Vitros ECi and Siemens HIV-1/O/2 enhanced on Advia Centaur
| Autor: | Greg Stewart, Christopher Bentsen, Elizabeth O. Mitchell, M. Kathleen Shriver, Olivier Bajzik, Mathieu Ferret |
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| Rok vydání: | 2013 |
| Předmět: |
Anti hiv 1
HIV Antigens Human immunodeficiency virus (HIV) HIV Infections Window period HIV Antibodies medicine.disease_cause Sensitivity and Specificity Antigen Virology Medicine Vitros ECi Humans ADVIA Centaur False Positive Reactions Serologic Tests Seroconversion Automation Laboratory business.industry Diagnostic Tests Routine virus diseases equipment and supplies Infectious Diseases Performance comparison HIV-1 business |
| Zdroj: | Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 58 |
| ISSN: | 1873-5967 |
| Popis: | Background A multisite study was conducted to evaluate the performance of the Bio-Rad 4th generation GS HIV Combo Ag/Ab EIA versus Abbott 4th generation ARCHITECT HIV Ag/Ab Combo. The performance of two 3rd generation EIAs, Ortho Diagnostics Anti-HIV 1 + 2 EIA and Siemens HIV 1/O/2 was also evaluated. Objective Study objective was comparison of analytical HIV-1 p24 antigen detection, sensitivity in HIV-1 seroconversion panels, specificity in blood donors and two HIV false reactive panels. Study design Analytical sensitivity was evaluated with International HIV-1 p24 antigen standards, the AFFSAPS (pg/mL) and WHO 90/636 (IU/mL) standards; sensitivity in acute infection was compared on 55 seroconversion samples, and specificity was evaluated on 1000 negative blood donors and two false reactive panels. Results GS HIV Combo Ag/Ab demonstrated better analytical HIV antigen sensitivity compared to ARCHITECT HIV Ag/Ab Combo: 0.41 IU/mL versus 1.2 IU/mL (WHO) and 12.7 pg/mL versus 20.1 pg/mL (AFSSAPS); GS HIV Combo Ag/Ab EIA also demonstrated slightly better specificity compared to ARCHITECT HIV Ag/Ab Combo (100% versus 99.7%). The 4th generation HIV Combo tests detected seroconversion 7–11 days earlier than the 3rd generation HIV antibody only EIAs. Conclusion Both 4th generation immunoassays demonstrated excellent performance in sensitivity, with the reduction of the serological window period (7–11 days earlier detection than the 3rd generation HIV tests). However, GS HIV Combo Ag/Ab demonstrated improved HIV antigen analytical sensitivity and slightly better specificity when compared to ARCHITECT HIV Ag/Ab Combo assay, with higher positive predictive values (PPV) for low prevalence populations. |
| Databáze: | OpenAIRE |
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