Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT

Abstract

Background HIV testing guidelines provided by the Centers for Disease Control and Prevention (CDC) are continually changing to reflect advancements in new testing technology. Evaluation of existing and new point-of-care (POC) HIV tests is crucial to inform testing guidelines and provide information to clinicians and other HIV test providers. Characterizing the performance of POC HIV tests using unprocessed specimens can provide estimates for the window period of detection, or the time from HIV acquisition to test positivity, which allows clinicians and other HIV providers to select the appropriate POC HIV tests for persons who may be recently infected with HIV. Objective This paper describes the protocols and procedures used to evaluate the performance of the newest POC tests and determine their sensitivity during early HIV infection. Methods Project DETECT is a CDC-funded study that is evaluating POC HIV test performance. Part 1 is a cross-sectional, retrospective study comparing behavioral characteristics and HIV prevalence of the overall population of the Public Health–Seattle & King County (PHSKC) Sexually Transmitted Disease (STD) Clinic to Project DETECT participants enrolled in part 2. Part 2 is a cross-sectional, prospective study evaluating POC HIV tests in real time using unprocessed whole blood and oral fluid specimens. A POC nucleic acid test (NAT) was added to the panel of HIV tests in June 2018. Part 3 is a longitudinal, prospective study evaluating seroconversion sensitivity of POC HIV tests through serial follow-up testing. For comparison, HIV-1 RNA and HIV-1/HIV-2 antigen/antibody tests are also performed for participants enrolled in part 2 or 3. A behavioral survey that collects information about demographics, history of HIV testing, STD history, symptoms of acute HIV infection, substance use, sexual behaviors in the aggregate and with recent partners, and use of pre-exposure prophylaxis and antiretroviral therapy is completed at each part 2 or 3 visit. Results Between September 2015 and March 2019, there were 14,990 Project DETECT–eligible visits (part 1) to the PHSKC STD Clinic resulting in 1819 part 2 Project DETECT study visits. The longitudinal study within Project DETECT (part 3) enrolled 27 participants with discordant POC test results from their part 2 visit, and 10 (37%) were followed until they had fully seroconverted with concordant positive POC test results. Behavioral survey data and HIV test results, sensitivity, and specificity will be presented elsewhere. Conclusions Studies such as Project DETECT are critical for evaluating POC HIV test devices as well as describing characteristics of persons at risk for HIV acquisition in the United States. HIV tests in development, including POC NATs, will provide new opportunities for HIV testing programs. International Registered Report Identifier (IRRID) RR1-10.2196/16332

Coronavirus Pandemic: a major public health crisis for the developed and developing world

“…As reported in The New England Journal of Medicine (NEJM) by Rothe et al in Germany that the transmission of SARS-COV-2 from asymptomatic case has already been reported [15]. As already performed for other important DNA/RNA viruses [16,17], a number of SARS-COV-2 detection tests/kits have been recently developed [18]. These kits included both molecular and immunological protocols, for the detection of SARS-COV-2 RNA [19] and circulating anti-SARS-COV-2 antibodies [20], respectively.…”

Seroconversion, seroreversion, and serowaffling among participants initiating antiretroviral therapy in Project DETECT

“…Project DETECT methods have been previously published. 25 Briefly, Project DETECT was a prospective cross-sectional study that evaluated performance of POC HIV tests in real-time with unprocessed whole blood (WB) and oral fluid (OF) specimens. Participants with discordant test results (including laboratory-based testing) were offered enrollment into a longitudinal study to evaluate the seroconversion sensitivity of tests.…”

Evaluation of SAMBA II: A Qualitative and Semiquantitative HIV Point-of-Care Nucleic Acid Test

“…Suspected acute HIV infection was defined as participant-reported potential HIV exposure, symptoms consistent with acute HIV infection, and/or a recent reactive HIV test. 44…”

“…Suspected acute HIV infection was defined as participant-reported potential HIV exposure, symptoms consistent with acute HIV infection, and/or a recent reactive HIV test. 44 A 4-mL tube of anticoagulated (EDTA) WB was used to perform all POC tests, including SAMBA II and Determine HIV-1/2 Antigen/Antibody (Ag/Ab) Combo (Abbott Molecular Inc., Des Plaines, IL) tests. Dried blood samples (DBS) were also spotted from this same tube, dried, and stored for future testing.…”

“…We evaluated the SAMBA II Qual and Semi-Q WB and plasma tests as part of the Diagnostic Evaluation To Expand Critical Testing Technologies (Project DETECT), a Centers for Disease Control and Prevention (CDC)-funded evaluation of multiple POC HIV tests. 44,45 We sought to determine the sensitivity, specificity, and concordance of the SAMBA tests with laboratory-based PCR assays as a diagnostic test in HIV-negative or newly diagnosed persons and as a monitoring tool among persons on ART.…”