Evaluation of the Performance of OraQuick Rapid HIV-1/2 Test Among Decedents in Kisumu, Kenya

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Abstract
Background: Estimating cause-related mortality among the dead is not common, yet for clinical and public health purposes, a lot can be learnt from the dead. HIV/AIDS accounted for the third most frequent cause of deaths in Kenya; 39.7 deaths per 100,000 population in 2019. OraQuick® has previously been validated on oral fluid and implemented as a screening assay for HIV self-testing in Kenya among living subjects. We assessed the feasibility and diagnostic accuracy of OraQuick® for HIV screening among decedents. Methods: Trained morticians collected oral fluid from 132 pre- and post-embalmed decedents aged >18 months at Jaramogi Oginga Odinga Teaching and Referral Hospital mortuary in western Kenya and tested for HIV using OraQuick®. Test results were compared with those obtained using the national HIV Testing Services algorithm on matched pre-embalming whole blood specimens as a gold standard (Determine® HIV and First Response® HIV 1-2-O). We calculated positive predictive values (PPV), negative predictive values (NPV), Area Under Curve (AUC), sensitivity and specificity of OraQuick® compared to the national HTS algorithm. Results: OraQuick® had similar sensitivity of 92.6%, (95.0% confidence interval (CI):75.7- 99.1) on pre- and post-embalmed samples compared to the gold standard. Specificity was 97.1% (95.0% CI:91.9-99.4) and 95.2%, (95.0% CI:89.2-98.4) pre and post embalming respectively. Pre and post embalming PPV was 89.3% (95.0% CI:71.8-97.7) and 83.3% (95.0% CI:65.3-94.4) respectively. The AUC pre-and post embalming was 94.9% (95% CI: 89.6 - 100) and 93.9% (95% CI, 88.5 - 99.4) respectively. Conclusions: The study showed a relatively high performance sensitivity and specificity of OraQuick® HIV-1/2 test among decedents, similar to those observed among living subjects. OraQuick® HIV-1/2 presents a convenient and less invasive screening test for surveillance of HIV among decedents within a mortuary setting.

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