Skip to main content
. 2022 Mar 10;2022(3):CD013208. doi: 10.1002/14651858.CD013208.pub2

Summary of findings 1. Summary of findings table.

Question What is the diagnostic accuracy of point‐of‐care tests to detect high viral load levels in people living with HIV?
Population People living with either HIV‐1 or HIV‐2 with suspected high viral loads attending health facilities
Index test Tests with point‐of‐care platforms for detecting HIV viral load (POC VL)
Comparator test None
Target condition High viral load
Reference test Central laboratory testing for HIV viral load
Role If accurate, index test results will be used to monitor viral load to decide on change of drug therapy. This will replace the reference standard of laboratory testing.
Limitations TEST: POC VL THRESHOLD: ≥ 1000 copies/mL defined as treatment failure
Risk of bias Mostly unclear risk of bias
Method of recruitment in most studies (except two studies) largely unclear.
Blinding of index and reference tests was not well‐reported, but is unlikely to have introduced bias.
Interval between index and reference tests not well‐reported, but is unlikely to have introduced bias.
Applicability of evidence to question Patient selection: all evaluations were done on samples from PLHIV retrieved from routine HIV/AIDS care centres or health facilities. Nearly half of the included studies had ART‐exclusive populations, whilst in the other studies the ART status was either unclear or mixed, comprising both ART‐experienced and ART‐naive participants. Nonetheless, this is reflective of routine care settings where mixed populations of ART‐experienced, ‐naive, and ‐non‐adherent are present due to barriers in ART initiation and adherence.
Index test: none of the evaluations was done at the patient's side (not true point‐of‐care tests). About half of the included POC VL tests were evaluated onsite in the health facility laboratory or in a peripheral laboratory near the patient. The other half were evaluated in a central or reference laboratory setting and not near the patient.a This is reflective of many resource‐limited settings where testing locations for POC tests are often blurred.
Findings TEST: POC VL THRESHOLD: ≥ 1000 copies/mL defined as the clinical threshold for treatment failure
Quantity of evidence Number of evaluations N = 20 Total participants N = 8659 Total with target condition N = 2522 Medianprevalence33.4%
Accuracy Test consequences Effect per 1000 patients tested at different prevalenceb settings
2.5% 10% 30% 40%
Sensitivity 96.6% (94.8 to 97.8) True‐positives (patients with high viral load or treatment failure) Will receive appropriate change in drug treatment 24 (24 to 24) 97 (95 to 98) 290 (284 to 293) 386 (379 to 391)
    False‐negatives (patients incorrectly classified as not having high viral load or treatment failure) Will not receive required
change in drug treatment
1 (1 to 1) 3 (2 to 5) 10 (7 to 16) 14 (9 to 21)
Specificity 95.7% (90.8 to 98.0) True‐negatives (patients without high viral load or treatment
failure)
Appropriately do not change
drug treatment
933 (885 to 956) 861 (817 to 882) 670 (636 to 686) 574 (545 to 588)
    False‐positives (patients incorrectly classified as having high viral load or treatment failure) Will receive unnecessary change
in drug treatment
42 (19 to 90) 39 (18 to 83) 30 (14 to 64) 26 (12 to 55)
Consistency Minimal heterogeneity for sensitivity between studies, but heterogeneity present for specificity, especially for laboratory evaluations of POC VL test        
Indirect test comparisonsc
Included tests Xpert HIV‐1, n = 8 SAMBA HIV‐1 Semi‐Q Test, n = 9 Alere q prototype for HIV‐1, n = 2 m‐PIMA HIV‐1/2, n = 1
Sensitivity No statistically significant difference between Xpert (97%) and SAMBA (95%); P = 0.21
Specificity No statistically significant difference between Xpert (96%) and SAMBA (97%); P = 0.43

Abbreviations: ART: antiretroviral therapy; PLHIV: people living with HIV; POC: point of care; VL: viral load

a'Near the patient' implies that testing was done onsite in the health facility laboratory or decentralized peripheral laboratory.
bValues of prevalence chosen to represent rates of detecting treatment failure on a single test, for low (2.5%), medium (10%), and high (30% and 40%) prevalence scenarios.
cIndirect test comparisons only possible where data were sufficient (i.e. Xpert versus SAMBA).