Validation study of an automated chemiluminiscence assay to detect HIV antibodies in oral fluid specimens

González, Victoria; López, Nàlia; Grifols, Joan Ramón; Egea, Laia; Rivaya, Belén; Wang-Wang, Jun Hao; Casabona, Jordi; Cardona, Père-Joan

doi:10.1007/s10096-022-04450-3

Cited by 2 publications

(1 citation statement)

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“…In this study, FSWs preferred urine HIV reagents, which may be related to the non-invasive operation of the rapid test kits. Although the diagnostic performance has been proven in some studies, 40 a low percentage of subjects in this study chose the oral secretion HIV antibody test kit, probably due to its expensive price and complicated operation.…”

Section: Discussionmentioning

confidence: 99%

Diagnostic performance evaluation of urine HIV-1 antibody rapid test kits in a real-life routine care setting in China

Lu,

Chen,

Liang

et al. 2024

BMJ Open

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ObjectivesTo evaluate the diagnostic performance of urine HIV antibody rapid test kits in screening diverse populations and to analyse subjects’ willingness regarding reagent types, purchase channels, acceptable prices, and self-testing.DesignsDiagnostic accuracy studiesParticipantsA total of 2606 valid and eligible samples were collected in the study, including 202 samples from female sex workers (FSWs), 304 persons with injection drug use (IDU), 1000 pregnant women (PW), 100 subjects undergoing voluntary HIV counselling and testing (VCT) and 1000 students in higher education schools or colleges (STUs). Subjects should simultaneously meet the following inclusion criteria: (1) being at least 18 years old and in full civil capacity, (2) signing an informed consent form and (3) providing truthful identifying information to ensure that the subjects and their samples are unique.ResultsThe sensitivity, specificity and area under the curve (AUC) of the urine HIV-1 antibody rapid test kits were 92.16%, 99.92% and 0.960 (95% CI: 0.952 to 0.968, p<0.001), respectively, among 2606 samples collected during on-site screenings. The kits showed good diagnostic performance in persons with IDU (AUC, 1.000; 95% CI, 1.000 to 1.000, p<0.001), PW (AUC, 0.999; 95% CI, 0.999 to 1.000, p<0.001) and FSWs (AUC, 1.000; 95% CI, 1.000 to 1.000, p<0.001). The AUC of the urine reagent kits in subjects undergoing VCT was 0.941 (95% CI: 0.876 to 0.978, p<0.001). The ‘acceptable price’ had the greatest influence on STUs (Pi=1.000) and PW (Pi=1.000), the ‘purchase channel’ had the greatest influence on subjects undergoing VCT (Pi=1.000) and persons with IDU (Pi=1.000) and the ‘reagent types’ had the greatest influence on FSWs (Pi=1.000).ConclusionsThe rapid urine test kits showed good diagnostic validity in practical applications, despite a few cases involving misdiagnosis and underdiagnosis.

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Section: Discussionmentioning

confidence: 99%