PMID: 18714458Aug 21, 2008Paper

Evaluation of Determine HIV-1/2 rapid diagnostic test by 4th generation ELISA using blood donors' serum at Felege Hiwot Referral Hospital, northwest Ethiopia

Ethiopian Medical Journal
Azene DessieWogenie Tamene

Abstract

The study aims to evaluate the HIV-1/2 rapid diagnostic test kit is routinely used to screen HIV infection for safe blood transfusion and VCT services in many parts of Ethiopia. A total of 324 sera were collected from consecutive blood donors from February to May 2006. All samples were screened for HIV infection using Determine HIV-1/2 (Abbott Japan) at hospital blood bank laboratory. Blindly, all serums were retested at Regional Health Research Laboratory using 4th generation ELISA (Vironostika HIV Uni-Form II AG/Ab) and Determine HIV-1/2 (Abbott lab). Discordant samples were repeatedly retested using the same ELISA and Determine HIV-1/2 to avoid technical errors. Finally, discordant results were resolved using Western Blot at the National HIV/AIDS Laboratory. Determine HIV-1/2 and ELISA showed 94.4% concordance in HIV antibody testing with fair Cohen's Kappa statistic value (0.68) among blood donors. The sensitivity, specificity, positive and negative predictive values of Determine HIV-1/2 were 60.5%, 98.9%, 88.5% and 94.9% respectively. As a rapid HIV screening test for blood donors, Determine HIV-1/2 showed poor sensitivity. Further evaluation at multiple centres is recommended to test its validity as a routine HIV screenin...Continue Reading

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