ArticleTropical medicine & international health : TM & IH2025
VISITECT® CD4 advanced disease assay in routine use: Diagnostic accuracy and usability, Ethiopia and Indonesia.
Article in Tropical medicine & international health : TM & IH, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Simplifying CD4 Testing to Support Advanced HIV Disease Care.The Journal of infectious diseases · 2026Article
- Accuracy and Acceptability of the VISITECT CD4 Advanced Disease Test Compared With the PIMA CD4 Test at the Point of Care as Part of the Advanced HIV Disease Care Package: A Mixed-Methods Study.Open forum infectious diseases · 2026Article
- VISITECT® CD4 advanced disease assay in routine use: Diagnostic accuracy and usability, Ethiopia and Indonesia.Tropical medicine & international health : TM & IH · 2025Article
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We assessed the diagnostic accuracy and usability of the rapid semiquantitative point of care VISITECT® CD4 Advanced Disease Assay, compared to routinely obtained CD4 counts among people living with HIV in Ethiopia and Indonesia. We consecutively enrolled people living with HIV aged ≥10 years who were newly diagnosed, had interrupted antiretroviral treatment for ≥3 months, or were feeling unwell. Venous blood was drawn to obtain CD4 counts on routinely available test instruments and a VISITECT® CD4 Advanced Disease Assay result. The sensitivity of VISITECT® CD4 Advanced Disease Assay was high (97.8%, 95% confidence interval [CI], 94.4-99.4%), but the specificity was low (32.7%, 95%CI, 27.9-37.8%). It significantly increased to 42.5% (95%CI, 33.2-52.1%) after retraining of laboratory staff, but remained low. The low specificity of VISITECT® CD4 Advanced Disease Assay was due to poor capacity in test reading by routine staff. Reading the test strip is error-prone and requires intensive and regular training. Reading aids may improve the usability of this essential point of care test.
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