BACKGROUND: Worldwide, many countries test for HIV infection using combination assays that simultaneously detect p24 antigen and HIV antibodies. One such assay, the ARCHITECT(®) HIV Ag/Ab Combo Assay (ARCHITECT), has recently been approved by the Food and Drug Administration (FDA) for use in the United States. OBJECTIVE: To evaluate the performance of ARCHITECT on well-characterized specimens from four CDC-funded studies. STUDY DESIGN: We evaluated 3386 HIV-infected, 7551 HIV-uninfected, and 58 acute HIV infection (AHI) specimens. HIV-infected specimens were repeatedly reactive by enzyme immunoassay (EIA) and Western blot (WB) or positive by nucleic acid amplification testing (NAAT). HIV-uninfected specimens were EIA- and NAAT-negative. AHI specimens were seronegative or indeterminate (using antibody-based EIAs, rapid tests or WB) and NAAT-positive. All specimens were de-identified and sent to Abbott Diagnostics for testing with ARCHITECT. ARCHITECT test results were compared to original study characterizations and were used to assess overall sensitivity and specificity and also sensitivity for AHI. ARCHITECT false-positive specimens with sufficient quantity were retested. RESULTS: Based on results from the initial ARCHITECT test, sensitivity was 99.94% (95% confidence interval [CI]: 99.79, 99.99) and specificity was 98.78% (95% CI: 98.51-99.01). Repeat testing resulted in corrected specificity of 99.50% (95% CI: 99.31, 99.64). Also, 48 AHI specimens (83%) were detected by this screening assay. CONCLUSION: The sensitivity and specificity of the ARCHITECT combination assay are very high and most AHIs were detected by the assay. Use of Ag/Ab combination assays may improve the number of AHIs identified relative to existing FDA-approved HIV-antibody only based serologic assays, particularly in high incidence populations. Published by Elsevier B.V.
BACKGROUND: Worldwide, many countries test for HIV infection using combination assays that simultaneously detect p24 antigen and HIV antibodies. One such assay, the ARCHITECT(®) HIV Ag/Ab Combo Assay (ARCHITECT), has recently been approved by the Food and Drug Administration (FDA) for use in the United States. OBJECTIVE: To evaluate the performance of ARCHITECT on well-characterized specimens from four CDC-funded studies. STUDY DESIGN: We evaluated 3386 HIV-infected, 7551 HIV-uninfected, and 58 acute HIV infection (AHI) specimens. HIV-infected specimens were repeatedly reactive by enzyme immunoassay (EIA) and Western blot (WB) or positive by nucleic acid amplification testing (NAAT). HIV-uninfected specimens were EIA- and NAAT-negative. AHI specimens were seronegative or indeterminate (using antibody-based EIAs, rapid tests or WB) and NAAT-positive. All specimens were de-identified and sent to Abbott Diagnostics for testing with ARCHITECT. ARCHITECT test results were compared to original study characterizations and were used to assess overall sensitivity and specificity and also sensitivity for AHI. ARCHITECT false-positive specimens with sufficient quantity were retested. RESULTS: Based on results from the initial ARCHITECT test, sensitivity was 99.94% (95% confidence interval [CI]: 99.79, 99.99) and specificity was 98.78% (95% CI: 98.51-99.01). Repeat testing resulted in corrected specificity of 99.50% (95% CI: 99.31, 99.64). Also, 48 AHI specimens (83%) were detected by this screening assay. CONCLUSION: The sensitivity and specificity of the ARCHITECT combination assay are very high and most AHIs were detected by the assay. Use of Ag/Ab combination assays may improve the number of AHIs identified relative to existing FDA-approved HIV-antibody only based serologic assays, particularly in high incidence populations. Published by Elsevier B.V.
Authors: Mars Stone; John Bainbridge; Ana M Sanchez; Sheila M Keating; Andrea Pappas; Wes Rountree; Chris Todd; Sonia Bakkour; Mark Manak; Sheila A Peel; Robert W Coombs; Eric M Ramos; M Kathleen Shriver; Paul Contestable; Sangeetha Vijaysri Nair; David H Wilson; Martin Stengelin; Gary Murphy; Indira Hewlett; Thomas N Denny; Michael P Busch Journal: J Clin Microbiol Date: 2018-07-26 Impact factor: 5.948
Authors: Pragna Patel; Berry Bennett; Timothy Sullivan; Monica M Parker; James D Heffelfinger; Patrick S Sullivan Journal: J Clin Virol Date: 2012-02-29 Impact factor: 3.168
Authors: Muazzam Nasrullah; Laura G Wesolowski; Steven F Ethridge; Kevin Cranston; Michael Pentella; Robert A Myers; James T Rudrik; Angela B Hutchinson; Spencer B Bennett; Barbara G Werner Journal: J Infect Date: 2016-05-26 Impact factor: 6.072
Authors: Joanne D Stekler; Kenneth Tapia; Janine Maenza; Claire E Stevens; George A Ure; Joshua D O'Neal; Aric Lane; James I Mullins; Robert W Coombs; Sarah Holte; Ann C Collier Journal: AIDS Res Hum Retroviruses Date: 2018-06-13 Impact factor: 2.205
Authors: Laura G Wesolowski; Kelly Wroblewski; Spencer B Bennett; Monica M Parker; Celia Hagan; Steven F Ethridge; Jeselyn Rhodes; Timothy J Sullivan; Imelda Ignacio-Hernando; Barbara G Werner; S Michele Owen Journal: J Clin Virol Date: 2015-01-24 Impact factor: 3.168
Authors: Joanne D Stekler; George Ure; Joshua D O'Neal; Aric Lane; Fred Swanson; Janine Maenza; Claire Stevens; Robert W Coombs; Joan Dragavon; Paul D Swenson; Matthew R Golden Journal: J Clin Virol Date: 2016-01-02 Impact factor: 3.168