Background
undiagnosed infection, PWH, HIV infection, viral suppression, HIV (PWH) [A 2019, infection, human immunodeficiency virus (HIV) infection
INFECTION, HIV INFECTION
Diagnosis of acute human immunodeficiency virus (HIV) infection followed by early antiretroviral therapy (ART) initiation serves both individual and public health, as it has health benefits for the person receiving treatment [Point-of-care (POC) testing which is defined as near-patient testing performed at home, clinic, doctor’s office, or a hospital has a fast turnaround time [POC HIV VL tests can also play an important role in the clinical management of HIV. Using these tests has the potential to improve VL monitoring, increase treatment efficacy, and reduce emergence of drug resistance. The adoption of POC HIV VL tests may improve individual health and also reduce transmission to others by facilitating viral suppression in people with HIV (PWH) [A 2019 review of 32 publications examined the performance and clinical utility of POC HIV VL tests [Another study, conducted between October 2014 to April 2016 in South Africa, compared the performance of POC Cepheid Xpert HIV-1 Qualitative test to the standard-of-care (SOC) Roche COBAS TaqMan HIV-1 Qualitative test for neonatal HIV diagnosis. The study demonstrated 100% sensitivity [95% Confidence Interval (CI): 88.4–100) and 99.9% specificity (95% CI: 99.7–100). The median time to result return for the POC test was 1 day (IQR: 0–1) as compared to 10 days (IQR: 9–13) for the comparator test (P < 0.0001) [Studies using the Cepheid GeneXpert HIV-1 Qualitative POC HIV VL test to assist with early infant HIV diagnosis in Kenya demonstrated a sensitivity of 94.1% and specificity of 99.8% compared to the SOC Roche CAP/CTM HIV-1 qualitative polymerase chain reaction assay [To assess new HIV testing technologies, it is necessary to evaluate their performance during the acute and early stages of infection and compare their performance with rapid HIV Ag/Ab tests and the gold-standard reference laboratory algorithm. Results of these tests can also help in timely identification of persons with undiagnosed infection, PWH who are not virally suppressed or may need reengagement in care, and those without HIV infection who may benefit from PrEP. This study can also measure the impact of POC HIV VL test results on key clinical decisions including immediate treatment decisions and linking patients to appropriate treatment and/or prevention services.