• Sickle Confirm offers highly reliable detection of sickle cell disease in routine clinical conditions. • Its low cost and field-adapted design make it practical, despite the need for basic equipment like a centrifuge. Sickle cell disease (SCD) remains underdiagnosed in sub-Saharan Africa due to limited access to reliable, affordable, and field-adapted diagnostic tools. This study aimed to independently assess the diagnostic performance of the Sickle Confirm™ test under routine clinical conditions in Senegal. A total of 100 participants were enrolled at the National Blood Transfusion Center (CNTS) in Dakar. Genotypes were confirmed via hemoglobin electrophoresis and compared to results from the Sickle Confirm™ test. The cohort included individuals with HbSS (56%), HbAS (21%), and HbAA (23%) genotypes. Diagnostic metrics, sensitivity, specificity, and Cohen’s kappa, were calculated with 95% confidence intervals (CIs). Sickle Confirm™ demonstrated perfect concordance with the reference method across all genotypes. The test identified all 56 HbSS, 21 HbAS, and 23 HbAA cases without any false positives or false negatives. Sensitivity and specificity were 100% (95% CI: HbSS – 93–100%; HbAS – 84–100%; HbAA – 85–100%), and Cohen’s kappa was 1. 00, indicating perfect agreement. The test maintained excellent performance in a real-world setting characterized by high temperatures (30–35 °C), relative humidity levels ranging from 55% to 80%, despite limited laboratory infrastructure. Sickle Confirm™ is an accurate, cost-effective (∼1/test), and field-adapted complement to existing sickle cell diagnostic tools. While it demonstrates excellent diagnostic accuracy, its current format requires a tabletop centrifuge and prior hematocrit measurement, which may limit use in some low-resource settings. Further evaluation of the qualitative version is needed to enhance practicality and broaden its applicability across healthcare settings in Africa.
Diaw et al. (Wed,) studied this question.