Background: Confirmatory assays for HIV diagnosis are not well implemented in low-income countries with limited infrastructures. Geenius™ HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test for the confirmation and differentiation of individual HIV-1/2 antibodies validated in venous whole blood, serum and plasma. However, dried blood specimens (DBS) are easier to collect, store and transport than plasma/serum in remote settings from limited resource countries and mobile populations.
Objectives: To evaluate the confirmatory assay Geenius™ HIV 1/2 for HIV diagnosis using DBS specimens.
Study design: We collected DBS from 70 Guinean women previously diagnosed as HIV-1 infected by rapid tests using whole blood samples in Equatorial Guinea and from 25 HIV-negative Guinean women and HIV-exposed infants diagnosed by molecular testing in Madrid. Geenius HIV 1/2 was performed by eluting two drops of dried blood from each patient and following the manufacturer instructions for the assay but using 40μl of the eluted blood as specimen. The results obtained were confirmed by western blot.
Results: Geenius™ HIV 1/2 successfully confirmed the HIV-1 positive and negative infection in all tested DBS specimens, providing 100% specificity [95% Confidence Interval (CI): 86.2%-100%]. No HIV 1/2 coinfections were found in the study cohort. This is the first report that proves a good performance of Geenius™ HIV 1/2 for the HIV-1 infection confirmation using only two drops of dried blood.
Conclusions: Our results approve the utility of this confirmatory assay using DBS when a lack of adequate infrastructure to collect, store or transport plasma/serum is found. DBS are a practical alternative to plasma/serum for HIV serological diagnosis.
Keywords: Antibody; Diagnosis; Dried blood spot; Geenius; HIV-1/2.
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