Point-of-care tests detecting HIV nucleic acids for diagnosis of HIV-1 or HIV-2 infection in infants and children aged 18 months or less

Abstract

Background The standard method of diagnosing HIV in infants and children less than 18 months is with a nucleic acid amplification test reverse transcriptase polymerase chain reaction test (NAT RT‐PCR) detecting viral ribonucleic acid (RNA). Laboratory testing using the RT‐PCR platform for HIV infection is limited by poor access, logistical support, and delays in relaying test results and initiating therapy in low‐resource settings. The use of rapid diagnostic tests at or near the point‐of‐care (POC) can increase access to early diagnosis of HIV infection in infants and children less than 18 months of age and timely initiation of antiretroviral therapy (ART). Objectives To summarize the diagnostic accuracy of point‐of‐care nucleic acid‐based testing (POC NAT) to detect HIV‐1/HIV‐2 infection in infants and children aged 18 months or less exposed to HIV infection. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (until 2 February 2021), MEDLINE and Embase (until 1 February 2021), and LILACS and Web of Science (until 2 February 2021) with no language or publication status restriction. We also searched conference websites and clinical trial registries, tracked reference lists of included studies and relevant systematic reviews, and consulted experts for potentially eligible studies. Selection criteria We defined POC tests as rapid diagnostic tests conducted at or near the patient site. We included any primary study that compared the results of a POC NAT to a reference standard of laboratory NAT RT‐PCR or total nucleic acid testing to detect the presence or absence of HIV infection denoted by HIV viral nucleic acids in infants and children aged 18 months or less who were exposed to HIV‐1/HIV‐2 infection. We included cross‐sectional, prospective, and retrospective study designs and those that provided sufficient data to create the 2 × 2 table to calculate sensitivity and specificity. We excluded diagnostic case control studies with healthy controls. Data collection and analysis We extracted information on study characteristics using a pretested standardized data extraction form. We used the QUADAS‐2 (Quality Assessment of Diagnostic Accuracy Studies) tool to assess the risk of bias and applicability concerns of the included studies. Two review authors independently selected and assessed the included studies, resolving any disagreements by consensus. The unit of analysis was the participant. We first conducted preliminary exploratory analyses by plotting estimates of sensitivity and specificity from each study on forest plots and in receiver operating characteristic (ROC) space. For the overall meta‐analyses, we pooled estimates of sensitivity and specificity using the bivariate meta‐analysis model at a common threshold (presence or absence of infection). Main results We identified a total of 12 studies (...

The Cascade of Care for Early Infant Diagnosis in Zimbabwe: Point of Care HIV Testing at Birth and 6–8 Weeks

“…Among infants with HIV diagnosed at birth who were initiated on ART, retention in care was high, comparable to retention in care for other children living with HIV, and higher than retention in care of infants identified as having HIV at birth using conventional testing. 3,15,19,20,24 In a 2022 randomized control trial comparing POC and central lab-based EID among HEI in Zambia, though not at birth, POC testing reduced delays in diagnosis and ART initiation, but both groups experienced high levels of care interruptions, virologic failures, and mortality at 12 months. 25 Recent model-based cost-effectiveness studies show investing in POC technology will be more cost-efficient for EID efforts than scaling up preexisting laboratory-based testing methods.…”

“…2 Infants who test positive for HIV often face delays in antiretroviral therapy (ART) initiation because of long turnaround times (TAT) for test results and loss-to-follow-up before results are returned. [3][4][5] Infants living with HIV who are untreated have a high risk for mortality, up to 10% at 2 months and 30%-40% between 3 and 4 months of age. 6,7 Early infant diagnosis (EID) of HIV and timely initiation of ART can significantly reduce mortality, limit the establishment of viral reservoirs, reduce HIV disease progression, and improve neurodevelopmental outcomes.…”

Incidence and Risks of HIV Infection, Medication Options, and Adverse Effects in Accidental Needle Stick Injuries: A Narrative Review

“…Nucleic acid-based tests (NATs) are also used in HIV testing to detect HIV-1 and HIV-2 infections. These tests utilize DNA polymerase chain reaction (PCR) tests to detect integrated viral DNA and RNA reverse transcription PCR (RT-PCR) to detect viral RNA [ 17 ]. These tests allow for the more rapid diagnosis of HIV as they target the actual viral code as opposed to the ELISA discussed above, which relies on antibody production.…”

Efficacy and safety of long‐acting cabotegravir versus oral tenofovir disoproxil fumarate‐emtricitabine as HIV pre‐exposure prophylaxis: A systematic review and meta‐analysis

“…At present, there is no effective drug to cure AIDS. Therefore, the prevention of HIV infection, especially the high‐risk groups of HIV infection, is an important measure to control the AIDS epidemic 5 . WHO guidelines strongly recommend oral PrEP containing TDF as part of a combined HIV prophylaxis approach for people at high risk of HIV infection 6 .…”

“…Therefore, the prevention of HIV infection, especially the high-risk groups of HIV infection, is an important measure to control the AIDS epidemic. 5 WHO guidelines strongly recommend oral PrEP containing TDF as part of a combined HIV prophylaxis approach for people at high risk of HIV infection. 6 Several randomized trials have shown that PrEP with daily oral TDF and emtricitabine (FTC) shows high efficacy among men who have sex with men and trans women, 7 heterosexual men and women, 8 and intravenous drug users.…”