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


Author
Kapaku et al.

Publication year
2017

Country

Type of approach
Dual

Type of assistance
Directly assisted

Specimen
Oral-fluid

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

Study design
Feasibility/acceptability

Sample size
1104

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

Methodology
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
n/a

Acceptability details
n/a

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
0.942

Specificity
0.997

Concordance
0.984

HIV positivity
n/a

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
n/a

Linkage to prevention, care and treatment
n/a


Study status
Ongoing

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