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Is OraQuick HIV-self-testing valid among intended users? Analysis from a clinical performance study in Lusaka, Zambia

Kapaku et al.

Publication year


Type of approach

Type of assistance
Directly assisted


Study population
General population: Participants from urban and rural communities and health facilities

Study design

Sample size

UNAIDS HIV prevalence (2017)
12.4 [11.8-13.0]

Consenting participants >16 years were randomly selected from urban and rural communities in Lusaka, Zambia from attendees at HIV counselling and testing facilities. Researchers demonstrated use of an oral fluid test and provided manufacturer's instructions for use. Participants conducted the test and recorded their results by themselves. Researchers repeated the oral HIVST and re-read participants' test strip. Following the Zambian national algorithm, a nurse blinded to oral HIVST results performed a series of rapid HIV diagnostic tests. A blood sample was tested for HIV following a reference standard algorithm consisting of fourth generation ELISA tests.

Summary of findings
There was good agreement (kappa=0.96) between participant and researcher-conducted oral HIVST. The sensitivity of oral HIVST was 95.5% (95%CI 89.7, 98.5) when compared to rapid diagnostic tests, and fell to 87.5% (95%CI 80.2, 92.8) when compared to laboratory testing. Specificity was 99.3% (95%CI 98.5, 99.7) compared with laboratory reference. Self-testers from the rural community achieved a lower sensitivity (74.3%, 95%CI 56.7, 87.5) compared to the urban community (92.3%, 95%CI 74.9, 99.1).


Acceptability details

Willingness to pay

Willingness to pay details




HIV positivity

Accuracy details
The sensitivity of oral HIVST was 94.2% (95%CI 90.4-96.8) when compared to rapid diagnostic test, with a specificity of 99.7% (95%CI 99.3-99.9) and fell to 87.6% (95%CI 83.0-91.4) when compared to the gold standard of the laboratory algorithm, specificity was 99.7% (95%CI 99.4-99.9). Self-testers from the rural community achieved a lower sensitivity (76.6%, 95%CI 62.0-87.7) compared to the urban community (88%, 95%CI 79.0-94.1), when compared to the gold standard. Agreement between HIVST and healthcare worker result 98.47%, kappa 0.9125.

Social harm

Linkage to prevention, care and treatment

Study status

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