TY - JOUR
T1 - Diagnostic Accuracy of HemotypeSC as a Point-of-Care Testing Device for Sickle Cell Disease
T2 - Findings from a Southwestern State in Nigeria and Implications for Patient Care in Resource-Poor Settings of sub-Saharan Africa
AU - Olatunya, Oladele S.
AU - Albuquerque, Dulcinea M.
AU - Fagbamigbe, Adeniyi F.
AU - Faboya, Opeyemi A.
AU - Ajibola, Ayotunde E.
AU - Babalola, Oluwatoyin A.
AU - Adebisi, Adewale O.
AU - Falusi, Adeyinka G.
AU - Adekile, Adekunle
AU - Costa, Fernando F.
N1 - Funding Information:
Authors also acknowledge with thanks the supports received from participants and their caregivers/parents during the study. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study received partial supports from grants No 2014/00984-3 from FAPESP, and grants No 2015/141693-0 from CNPq, Brazil.
Publisher Copyright:
© The Author(s) 2021.
PY - 2021
Y1 - 2021
N2 - This study aimed to determine the performance of a rapid, point-of-care testing device (HemotypeSC)™ for diagnosing sickle cell disease (SCD) relative to 2 commonly-used methods compared to DNA polymerase chain reaction (PCR) as the reference standard. The diagnostic performance of (HemotypeSC)™ in diagnosing SCD and determining various other Hb genotypes relative to high performance liquid chromatography (HPLC) and cellulose acetate Hb electrophoresis in alkaline buffer (CAE) was investigated among 156 participants aged 4 to 23 years in Ekiti, Southwest Nigeria. PCR was considered as the reference method/gold standard. The sensitivity and specificity for SS, SC, AS, AC, and AA genotypes by HemotypeSC and HPLC when compared with PCR, were each 100%. Similarly, their positive and negative predictive values were each 100%. However, sensitivity and specificity 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 HbAC individuals that were correctly identified by PCR and both HemotypeSC, and HPLC, thus representing 100% HbAC misdiagnosis. In conclusion, this study shows that HemotypeSC has perfect concordance with PCR and 100% accuracy in diagnosing SCD in the population tested. Its ease of use, accuracy and other attributes make it suitable for use in sub-Saharan Africa for rapid determination of Hb genotypes.
AB - This study aimed to determine the performance of a rapid, point-of-care testing device (HemotypeSC)™ for diagnosing sickle cell disease (SCD) relative to 2 commonly-used methods compared to DNA polymerase chain reaction (PCR) as the reference standard. The diagnostic performance of (HemotypeSC)™ in diagnosing SCD and determining various other Hb genotypes relative to high performance liquid chromatography (HPLC) and cellulose acetate Hb electrophoresis in alkaline buffer (CAE) was investigated among 156 participants aged 4 to 23 years in Ekiti, Southwest Nigeria. PCR was considered as the reference method/gold standard. The sensitivity and specificity for SS, SC, AS, AC, and AA genotypes by HemotypeSC and HPLC when compared with PCR, were each 100%. Similarly, their positive and negative predictive values were each 100%. However, sensitivity and specificity 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 HbAC individuals that were correctly identified by PCR and both HemotypeSC, and HPLC, thus representing 100% HbAC misdiagnosis. In conclusion, this study shows that HemotypeSC has perfect concordance with PCR and 100% accuracy in diagnosing SCD in the population tested. Its ease of use, accuracy and other attributes make it suitable for use in sub-Saharan Africa for rapid determination of Hb genotypes.
UR - https://www.scopus.com/pages/publications/85106246166
UR - https://www.scopus.com/pages/publications/85106246166#tab=citedBy
U2 - 10.1177/2333794X211016789
DO - 10.1177/2333794X211016789
M3 - Article
AN - SCOPUS:85106246166
SN - 2333-794X
VL - 8
SP - 1
EP - 10
JO - Global Pediatric Health
JF - Global Pediatric Health
ER -