Monica M Parker1, S Berry Bennett2, Timothy J Sullivan3, Sally Fordan4, Laura G Wesolowski5, Kelly Wroblewski6, Anne M Gaynor7. 1. Wadsworth Center, New York State Department of Health, 120 New Scotland Avenue, Albany, NY, 12208, United States. Electronic address: monica.parker@health.ny.gov. 2. Florida Bureau of Public Health Laboratories, 1217 Pearl St., Jacksonville, FL, 32202, United States. Electronic address: Berry.Bennett@FLHealth.gov. 3. Wadsworth Center, New York State Department of Health, 120 New Scotland Avenue, Albany, NY, 12208, United States. Electronic address: timothy.sullivan@health.ny.gov. 4. Florida Bureau of Public Health Laboratories, 1217 Pearl St., Jacksonville, FL, 32202, United States. Electronic address: Sally.Fordan@FLHealth.gov. 5. Centers for Disease Control and Prevention, United States. 6. Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD, 20910, United States. Electronic address: Kelly.wroblewski@aphl.org. 7. Association of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD, 20910, United States. Electronic address: anne.gaynor@aphl.org.
Abstract
BACKGROUND: The capacity of HIV Antigen/Antibody (Ag/Ab) immunoassays (IA) to detect HIV-1 p24 antigen has resulted in improved detection of HIV-1 infections in comparison to Ab-only screening assays. Since its introduction in the US, studies have shown that the Determine HIV-1/2 Ag/Ab Combo assay (Determine Ag/Ab) detects HIV infection earlier than laboratory-based IgM/IgG-sensitive IAs, but its sensitivity for HIV-1 p24 Ag detection is reduced compared to laboratory-based Ag/Ab assays. However, further evaluation is needed to assess its capacity to detect acute HIV-1 infection. OBJECTIVE: To assess the performance of Determine Ag/Ab in serum from acute HIV-1 infections. STUDY DESIGN: Select serum specimens that screened reactive on a laboratory-based Ag/Ab IA or IgM/IgG Ab-only IA, with a negative or indeterminate supplemental antibody test and detectable HIV-1 RNA were retrospectively tested with Determine Ag/Ab. Results were compared with those of the primary screening immunoassay to evaluate concordance within this set of algorithm-defined acute infections. RESULTS: Of 159 algorithm-defined acute HIV-1 specimens, Determine Ag/Ab was reactive for 105 resulting in 66.0% concordance. Of 125 that were initially detected by a laboratory-based Ag/Ab IA, 81 (64.8%) were reactive by Determine Ag/Ab. A total of 34 acute specimens were initially detected by a laboratory-based IgM/IgG Ab-only IA and 24 (70.6%) of those were reactive by Determine Ag/Ab. CONCLUSIONS: Due to their enhanced sensitivity, laboratory-based Ag/Ab IAs continue to be preferred over the Determine Ag/Ab as the screening method used by laboratories conducting HIV diagnostic testing on serum and plasma specimens.
BACKGROUND: The capacity of HIV Antigen/Antibody (Ag/Ab) immunoassays (IA) to detect HIV-1 p24 antigen has resulted in improved detection of HIV-1 infections in comparison to Ab-only screening assays. Since its introduction in the US, studies have shown that the Determine HIV-1/2 Ag/Ab Combo assay (Determine Ag/Ab) detects HIV infection earlier than laboratory-based IgM/IgG-sensitive IAs, but its sensitivity for HIV-1 p24 Ag detection is reduced compared to laboratory-based Ag/Ab assays. However, further evaluation is needed to assess its capacity to detect acute HIV-1 infection. OBJECTIVE: To assess the performance of Determine Ag/Ab in serum from acute HIV-1 infections. STUDY DESIGN: Select serum specimens that screened reactive on a laboratory-based Ag/Ab IA or IgM/IgG Ab-only IA, with a negative or indeterminate supplemental antibody test and detectable HIV-1 RNA were retrospectively tested with Determine Ag/Ab. Results were compared with those of the primary screening immunoassay to evaluate concordance within this set of algorithm-defined acute infections. RESULTS: Of 159 algorithm-defined acute HIV-1 specimens, Determine Ag/Ab was reactive for 105 resulting in 66.0% concordance. Of 125 that were initially detected by a laboratory-based Ag/Ab IA, 81 (64.8%) were reactive by Determine Ag/Ab. A total of 34 acute specimens were initially detected by a laboratory-based IgM/IgG Ab-only IA and 24 (70.6%) of those were reactive by Determine Ag/Ab. CONCLUSIONS: Due to their enhanced sensitivity, laboratory-based Ag/Ab IAs continue to be preferred over the Determine Ag/Ab as the screening method used by laboratories conducting HIV diagnostic testing on serum and plasma specimens.
Authors: Julia Budzyńska; Rafał Patryn; Ilona Kozioł; Magdalena Leśniewska; Agnieszka Kopystecka; Tomasz Skubel Journal: Int J Environ Res Public Health Date: 2022-07-30 Impact factor: 4.614
Authors: Claudia E Frola; Virginia Zalazar; Nadir Cardozo; María L Vázquez; Inés Arístegui; Mar Lucas; Ana Gun; Pedro Cahn; Omar Sued Journal: PLoS One Date: 2020-03-19 Impact factor: 3.240
Authors: Anne M Neilan; Jennifer Cohn; Emma Sacks; Aditya R Gandhi; Patricia Fassinou; Rochelle P Walensky; Marc N Kouadio; Kenneth A Freedberg; Andrea L Ciaranello Journal: Open Forum Infect Dis Date: 2021-05-13 Impact factor: 3.835