Diagnostic Accuracy of HemotypeSC as a Point-of-Care Testing Devicefor Sickle Cell Disease: Findings from a Southwestern State in Nigeria andImplications for Patient Care in Resource-Poor Settings of sub-SaharanAfrica

摘要

This study aimed to determine the performance of a rapid, point-of-care testingdevice (HemotypeSC)™ for diagnosing sickle cell disease (SCD) relative to 2commonly-used methods compared to DNA polymerase chain reaction (PCR) as thereference standard. The diagnostic performance of (HemotypeSC)™ in diagnosingSCD and determining various other Hb genotypes relative to high performanceliquid chromatography (HPLC) and cellulose acetate Hb electrophoresis inalkaline buffer (CAE) was investigated among 156 participants aged 4 to 23 yearsin Ekiti, Southwest Nigeria. PCR was considered as the reference method/goldstandard. The sensitivity and specificity for SS, SC, AS, AC, and AA genotypesby HemotypeSC and HPLC when compared with PCR, were each 100%. Similarly, theirpositive and negative predictive values were each 100%. However, sensitivity andspecificity for identifying these Hb genotypes by CAE were 100, 100, 96.5, 0,99.2%, and 99, 100, 92.9, 0, 91.7%. Also, CAE did not identify any of the 2 HbACindividuals that were correctly identified by PCR and both HemotypeSC, and HPLC,thus representing 100% HbAC misdiagnosis. In conclusion, this study shows thatHemotypeSC has perfect concordance with PCR and 100% accuracy in diagnosing SCDin the population tested. Its ease of use, accuracy and other attributes make itsuitable for use in sub-Saharan Africa for rapid determination of Hbgenotypes.