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J Clin Virol. 2013 Dec;58 Suppl 1:e79-84. doi: 10.1016/j.jcv.2013.08.009.

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.

Author information

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.

KEYWORDS:

4th Generation; AFSSAPS; Ab; Ag/Ab combination; Agence Francaise de sécurité sanitaire des produits de santé; CI; EIA; FDA; False positives; Food and Drug Administration; IRB; IU; Institutional Review Board; PCR; PPV; RNA; S/CO; Specificity; WHO; World Health Organization; antibody; confidence interval; enzyme immunoassay; glycoprotein; gp; international unit; mL; milliliter; p-NAAT; pg; picogram; polymerase chain reaction; pooled nucleic acid amplification tests; positive predictive value; ribonucleic acid; signal to cut-off

PMID:
24342482
DOI:
10.1016/j.jcv.2013.08.009
[Indexed for MEDLINE]

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