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

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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 screening test in blood donors. Use of a combination of rapid assays is also recommended for screening of HIV infection among the donor population.