Home›Infectious Disease› Systematic review shows rapid diagnostic tests offer faster, cheaper HIV detection for LAI-PrEP users with low certainty evidence
Systematic review shows rapid diagnostic tests offer faster, cheaper HIV detection for LAI-PrEP users with low certainty evidenceRapid tests find HIV just as well as lab tests but cost less and work faster
PLoS medicinePublished April 23, 2026Study authors: Tieosapjaroen Warittha, Williams Eloise, Johnson Cheryl C, Baptista Da Silva Carlota, Barr-DiChiara …PubMed ↗DOI ↗Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease
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Key Takeaway
Consider adopting RDTs for LAI-PrEP users; evidence certainty is low and detection rates are similar to NAT.
This systematic review and meta-analysis assessed the clinical utility, programme delivery, and performance of various HIV testing strategies, including rapid diagnostic tests (RDTs), laboratory-based immunoassays, nucleic acid testing (NAT), and HIV self-testing. The analysis included 8,171 LAI-PrEP users drawn from four randomised controlled trials and 38 additional reports representing 22 studies across 15 countries. The primary outcomes focused on HIV detection rates, while secondary outcomes included turnaround time, treatment initiation time, test costs, and predictive values.
Key findings indicated that HIV detection rates were similar across strategies, with an odds ratio of 0.66 (95% confidence interval: 0.29-1.50; P = 0.87). Specifically, 9 of 8,171 users tested positive with RDTs versus 14 of 8,171 with NAT. While detection rates were comparable, RDTs enabled faster turnaround (same-day versus up to 7 days) and more rapid treatment initiation (1 day versus 6-9 days). Additionally, RDTs demonstrated lower test costs at US$4 compared to US$22 for other methods. Negative predictive value was approximately 100% at LAI-PrEP initiation for all strategies, and positive predictive value was comparable at continuation (~55%).
However, the review noted that 11 of 8,171 cases experienced delayed HIV detection with RDTs versus 0 of 8,171 with NAT. False-positive results occurred occasionally with NAT (7 of 2,483), leading to unnecessary pre-exposure prophylaxis holds or discontinuation in 7 of 2,483 cases. The authors acknowledged that assessment of performance accuracy may introduce selection bias and that overall certainty of evidence was low. Most included studies were observational cohorts or non-randomised comparator studies, and there was limited evidence regarding HIV self-testing for LAI-PrEP delivery.
Practice relevance is tempered by the lack of prospective or modelling evidence showing clinical benefit at a population level for NAT detecting HIV before resistance emerged. Despite these limitations, the authors suggest that adopting new WHO guidance supporting RDTs can enable simpler, more affordable, and user-centred HIV testing approaches for this population.
People using long-acting HIV prevention need reliable ways to check for the virus. A massive review looked at 8,171 users across 15 countries to compare rapid diagnostic tests against standard lab methods. The results show that rapid tests find HIV just as effectively as more expensive lab-based immunoassays or nucleic acid testing. This means health programs can save money and get results back to patients much faster without losing accuracy.
Getting a positive result means starting life-saving treatment quickly. With rapid tests, people started treatment in just one day compared to six to nine days with lab tests. This speed matters because it gets medicine into bodies sooner. The review also found that rapid tests cost only four dollars per test versus twenty-two dollars for lab methods. This affordability makes it easier to reach more people who need protection.
While lab tests occasionally produced false alarms, rapid tests performed well at ruling out infection. The overall certainty of the evidence was low because many studies were observational rather than fully controlled trials. However, the findings support a shift toward simpler, user-centered testing that fits better into real-world health programs.
What this means for you:
Rapid tests match lab accuracy for long-acting prevention while saving money and time.
BACKGROUND: Long-acting injectable pre-exposure prophylaxis (LAI-PrEP) is a highly effective biomedical intervention for the prevention of HIV acquisition. There is a strong interest among communities and policymakers for LAI-PrEP scale-up, accelerating the demand for clear guidance on testing approaches that balance accuracy with scalability. Unlike oral pre-exposure prophylaxis, LAI-PrEP may overcome adherence challenges, such as difficulty with frequent clinic visits. However, LAI-PrEP results in prolonged subtherapeutic drug levels after discontinuation, which can increase the risk of drug resistance among those who have an undetected HIV infection. This systematic review evaluates how different HIV testing strategies, including rapid diagnostic tests (RDTs), laboratory-based immunoassays and nucleic acid testing (NAT), affect clinical utility and programme delivery of LAI-PrEP.
METHODS AND FINDINGS: We searched databases and retrieved studies up to April 8, 2025, and supplemented findings with data collected through a World Health Organization (WHO) survey among ongoing and completed LAI-PrEP implementation studies. We included publications reporting original or primary data on clinical, diagnostic and resource-use outcomes of HIV testing for LAI-PrEP. Meta-analyses were conducted using random-effects models. Chi-square tests were used to examine differences between related outcomes. Certainty of evidence was determined using the GRADE methodology (Prospero: CRD42024605562). Risk Of Bias In Non-randomised Studies of Interventions, Version 2 (ROBINS-I V2) assessment tool was used to assess bias for non-randomised comparative studies. Of 7,698 records identified, 38 reports representing 22 studies (cabotegravir: 20, lenacapavir: 2) across 15 countries were included. The overall certainty of evidence was low. Most were observational cohorts (n = 13) or non-randomised comparator studies (n = 7). Among 8,171 LAI-PrEP users in four randomised controlled trials, HIV detection rates were similar across strategies (9/8171 (RDT) versus 14/8171 (NAT) (Odds ratio (OR) 0.66 (95% confidence interval: 0.29-1.50; P = 0.87)), with no difference in adverse events. Compared with laboratory-based tests, RDTs enabled faster turnaround (same-day versus up to 7 days), more rapid treatment initiation (1 day versus 6-9 days), and lower test costs (US$4 versus US$22). All tests had similar negative predictive value (~100%) at LAI-PrEP initiation and comparable positive predictive value (~55%) at continuation. There was little difference in delayed HIV detection (11/8171 (RDT) versus 0/8171 (NAT)). In the HPTN 083 trial, NAT use was occasionally associated with false-positive results, leading to unnecessary PrEP holds or discontinuation (7/2483). NAT might have detected HIV before resistance emerged, though no prospective or modelling evidence showed clinical benefit at a population level. There was limited evidence of HIV self-testing for LAI-PrEP delivery. We noted that our assessment of performance accuracy in different testing strategies may introduce selection bias.
CONCLUSIONS: RDT-based testing strategies have comparable accuracy to laboratory-based strategies and are more accessible and scalable, which can ensure that testing does not become a barrier to accessing or continuing LAI-PrEP. As countries expand access to LAI-PrEP amid increasingly constrained resources, adoption of new WHO guidance supporting the use of RDTs can enable simpler, more affordable, and user-centred HIV testing approaches.
