Elizabeth O Mitchell1, Greg Stewart2, Olivier Bajzik3, Mathieu Ferret4, Christopher Bentsen3, M Kathleen Shriver3. 1. Bio-Rad Laboratories, 6565 185th Avenue NE, Redmond, WA 98052, United States. Electronic address: Elizabeth_mitchell@bio-rad.com. 2. Bio-Rad Laboratories, 4000 Alfred Nobel Drive, Hercules, CA 94547, United States. 3. Bio-Rad Laboratories, 6565 185th Avenue NE, Redmond, WA 98052, United States. 4. Bio-Rad Laboratories, 3 Boulevard Raymond Poincare, Marnes La Coquette 92430, France.
Abstract
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.
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-1p24 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-1p24 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.
Authors: Estelle Piwowar-Manning; Jessica M Fogel; Paul Richardson; Shauna Wolf; William Clarke; Mark A Marzinke; Agnès Fiamma; Deborah Donnell; Michal Kulich; Jessie K K Mbwambo; Linda Richter; Glenda Gray; Michael Sweat; Thomas J Coates; Susan H Eshleman Journal: J Clin Virol Date: 2014-11-27 Impact factor: 3.168
Authors: Mark M Manak; Linda L Jagodzinski; Ashley Shutt; Jennifer A Malia; Mike Leos; Jason Ouellette; Siriwat Akapirat; Donn L Colby; Nittaya Phanuphak; Leigh Anne Eller; Merlin L Robb; Mark de Souza; Jintanat Ananworanich; Sheila A Peel Journal: J Clin Microbiol Date: 2019-09-24 Impact factor: 5.948