Evaluation of a rapid human immunodeficiency virus test at two community clinics in Kwazulu-Natal.

Objectives: To establish whether the Determine (Abbott, Tokyo, Japan) HIV antibody test is suitable as an on-site rapid HIV test at primary health care centres by determining its sensitivity and specificity compared with the standard enzyme-linked immunoassay (ELISA) test.
Design: Prospective field evaluation study of a rapid HIV test compared with an ELISA.
Setting: KwaDabeka clinic and St Mary's Hospital, urban primary health care clinics in the Durban western metropolitan area.
Subjects: Women attending antenatal clinics and those presenting at onset of labour.
Outcome Measures: Performance of the rapid test versus conventional ELISA testing, sensitivity, specificity, feasibility of implementing the test at primary health care clinics, prevalence of HIV infection at study sites and its association with patient booking status.
Results: A total of 323 specimens were tested from patients from two community clinics, KwaDabeka (N = 159) and St Mary's (N = 164). The overall HIV prevalence was 45.5%. There was a significant difference in HIV prevalence (P < 0.001) between KwaDabeka (35.2%) and St Mary's (55.5%). Of the participants 49.2% were from KwaDabeka clinic and 50.8% from St Mary's Hospital. Overall, HIV prevalence among unbooked participants was 43.0%, and among booked participants 46.3%. This was not statistically different (P = 0.612) between the two clinics. The rapid test showed a sensitivity and specificity of 100% when compared with a conventional diagnostic ELISA test.
Conclusion: The Determine rapid HIV antibody test is sensitive, specific, easy to perform and provides a valuable method for HIV testing especially in settings with limited access to laboratory infrastructures and trained laboratory staff.