Diagnostic accuracy of HIV test kits, Genscreen Ultra and Bioelisa

Abstract

Purpose

Genetic diversities in different countries affect the performance of HIV test kits. Therefore, WHO recommends evaluation of every HIV test kit in countries’ context before its use. Therefore, this study aimed to evaluate the performance of Genscreen ULTRA HIV Ag–Ab and Bioelisa.

Materials and methods

The study had used 400 characterized plasma samples obtained from CDC Atlanta bio-bank derived from Africa, USA, and Thailand.

Results

Diagnostic performance of both test kits under evaluation was assessed at 95% CI. Genscreen ULTRA HIV Ag–Ab had sensitivity and negative predictive value of 99.5% [95% CI, 97.2–99.9] and the specificity and positive predictive value of 98.5% [95% CI, 95.7–99.7]. Bioelisa HIV test kit had exhibited sensitivity and negative predictive value of 99% [95% CI, 96.4–99.7] and specificity and positive predictive value of 98.5% [95% CI, 95.7–99.7]. Both test kits were able to detect almost all samples with HIV-2, dual infections, and seroconversion.

Conclusion

Both the test kits were highly sensitive and specific in detecting HIV. However, there are still few samples containing HIV antibody which were not identified by both kits. Therefore, additional screening measures should be done in using these assays for blood transfusion and organ transplantation. In addition, the study can be used as a reference by other African countries.

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Keywords:

• ELISA
• sensitivity
• positive predictive
• specificity
• validation

Acknowledgments

The study team is grateful to the Ethiopian Pubic Health Institute for supporting the evaluation. We would also like to acknowledge CDC Atlanta, International Laboratory Branch for providing us with the characterized plasma panels used for the study. Particularly our appreciation goes to Dr Bharat S Parekh and Dr Clement Zeh. Finally, we also appreciate Dr Tsigereda Kifle, Mr Tesfaye Tilahun, and Mr Mulusew Getaneh for their valuable contributions to the successful completion of the study.

Disclosure

The authors report no conflicts of interest in this work.