Diagnostic accuracy of the VISITECT CD4 lateral-flow assay for screening advanced HIV disease: A systematic review and meta-analysis.
Behailu Taye Gebremeskele, Haile Tesfaye, Workineh Woldeselassie Hammeso et al.
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In 30 seconds
This systematic review and meta-analysis assessed the diagnostic accuracy of the VISITECT-CD4 lateral-flow assay for advanced HIV disease, using flow cytometry as the comparator. Ten studies included 6962 people with HIV. Pooled sensitivity was 98% (95% CI: 94-99%) and specificity was 71% (95% CI: 56-85%), with an area under the curve of 0.95. Sensitivity was similar for capillary and venous blood. The authors concluded that the assay met the target product profile’s sensitivity requirement for point-of-care CD4 tests, while pooled specificity was below its target.
Key findings
- Across ten studies and 6962 people with HIV, pooled sensitivity was 98% (95% CI: 94-99%) and specificity was 71% (95% CI: 56-85%).
- The assay’s area under the curve was 0.95.
- Sensitivity was 96% (95% CI: 93-97%) with capillary blood and 99% (95% CI: 93-100%) with venous blood.
Why it matters
Reliable point-of-care identification of advanced HIV disease can support timely screening and prophylaxis for opportunistic infections, including in decentralized settings. The high pooled sensitivity and similar performance with capillary and venous samples are encouraging for screening, but the lower pooled specificity means positive results may require careful interpretation within the diagnostic pathway.
What to keep in mind
Pooled specificity was below the target product profile’s ≥80% target. The authors also identified a need for further research in South American and Asian populations.