Diagnostic Accuracy of HemotypeSC as a Point-of-Care Testing Device for Sickle Cell Disease: Findings from a Southwestern State in Nigeria and Implications for Patient Care in Resource-Poor Settings of sub-Saharan Africa

Olatunya, Oladele Simeon; Albuquerque, Dulcinea M.; Fagbamigbe, Adeniyi Francis; Faboya, Opeyemi Ayodeji; Ajibola, Ayotunde Emmanuel; Babalola, O.; Adebisi, Adewale O.; Falusi, Adeyinka G.; Adekile, Adekunle; Costa, Fernando Ferreira

doi:10.1177/2333794x211016789

Cited by 8 publications

(8 citation statements)

References 39 publications

(121 reference statements)

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“…Our findings agree with previous studies suggesting a specificity and specificity of 100% (Nnodu et al, 2019) (Olatunya et al, 2021 for HbS and HbC in ideal conditions using the standard HemoTypeSC POCT procedure. Nnodu et al, worked on 1,121 samples and compared HemoTypeSC POCT with HPLC (GOLD Standard).…”

Section: Resultssupporting

confidence: 93%

“…They got a sensitivity of; 0.989 (AA), 0.983 (AS), 1.000 (SS), 0.933 (AC), and Specificity of: 0.993 (AA), 0.992 (AS), 0.999 (SS), 1.000 (AC). Olatunya et al (2021) in 2021 compared Cellulose Acetate Electrophoresis, HemoTypeSC POCT and HPLC methods with PCR in 158 participants. HemoTypeSC showed both a Sensitivity and Specificity of 1.00 (100%) for AA, AC, AS, SC, and SS.…”

Section: Discussionmentioning

confidence: 99%

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Using dried blood spot on HemoTypeSC™, a new frontier for newborn screening for sickle cell disease in Nigeria

et al. 2022

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Background: HemoTypeSC is a rapid, point-of-care testing (POCT) device for sickle cell disease (SCD) that traditionally uses the capillary blood from heel stick collected at the point of testing, a procedure that makes mass screening cumbersome and less cost-effective. Using dried blood spots (DBS) on HemoTypeSC could mitigate this challenge. Therefore, this study aimed to determine the feasibility of eluting blood from DBS to read on HemoTypeSC.Methods: DBS and fresh samples from heel sticks were collected from 511 newborns at the immunization clinics of six Primary Health Centers in Abuja, Nigeria. The two samples from each newborn were analyzed using HemoType SC and then compared with the result of the isoelectric focusing (IEF) test.Results: Of the 511 newborns, 241 were males and 270 were females. Standard HemoTypeSC (using fresh samples collected from heel sticks) and HemoTypeSC using DBS identified 404 (79.0%) HbAA, 100 (19.6%) HbAS, 6 (1.2%) HbSS, and 1 (0.2%) HbAC phenotypes. The IEF tests identified 370 (72.4%) HbAA, 133 (26.0%) HbAS, 5 (1.0%) HbSS, and 3 (0.6%) HbAC phenotypes. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy of HemoTypeSC using DBS, compared to standard HemoTypeSC POCT was 100%. IEF method showed for AA, AS, AC phenotypes; sensitivity; 84.7%, 67%,100% respectively, specificity; 67.6%, 86%, 99% respectively, PPV; 91.2%, 53%, 50% respectively, NPV; 52.7%, 91%, 100% respectively. For SS phenotype, IEF showed 100% specificity, sensitivity, PPV and NPV.Conclusion: HemoTypeSC test using dried blood spot is as accurate as the standard point-of-care HemoTypeSC test. The use of DBS on HemoTypeSC could ensure better efficiency and cost-effectiveness in mass newborn screening for SCD.

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Section: Resultssupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Using dried blood spot on HemoTypeSC™, a new frontier for newborn screening for sickle cell disease in Nigeria

et al. 2022

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“…In this study, we evaluated the diagnostic accuracy of two POC tests sickle SCAN® and hemotypeSC™ and both test methods displayed high sensitivity and specificity as compared to reference methods. HemotypeSC™ displayed the sensitivity and specificity of 100% in identifying all Hb phenotypes, all study participants were correctly identified and this is in agreement with previous studies done in SSA to assess the feasibility of the test in limited‐resource countries 18–20 . On the other hand, sickle SCAN® showed sensitivity and specificity of 99.5% and 100%, respectively, in identified all Hb phenotypes.…”

Section: Discussionsupporting

confidence: 89%

“…HemotypeSC™ displayed the sensitivity and specificity of 100% in identifying all Hb phenotypes, all study participants were correctly identified and this is in agreement with previous studies done in SSA to assess the feasibility of the test in limited-resource countries. [18][19][20] On the other hand, sickle SCAN ® showed sensitivity and specificity of 99.5% and 100%, respectively, in identified all Hb phenotypes. Sickle SCAN ® was able to identify Hb AA and Hb SS perfectly, but as compared to hemotypeSC™ the sensitivity for sickle SCAN ® in identifying Hb AS declined to 97.0%, the decline of sickle SCAN in detecting Hb AS has also been reported in the previous study.…”

Section: Discussionmentioning

confidence: 97%

Potential of point of care tests for newborn screening for sickle cell disease: Evaluation of HemotypeSC™ and sickle SCAN® in Tanzania

Christopher

Josephat

Kaywanga

et al. 2022

Int J Lab Hematology

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Background: Sickle cell disease (SCD) is an important cause of <5 mortality. In Tanzania, it is estimated up to 11 000 children are born with SCD annually, making this the fifth country with the highest SCD annual births worldwide. The biggest challenge of expanding the service of newborn screening for SCD as the national health intervention in Tanzania is due to the high cost of the currently used assays and lack of rapid screening methods. Therefore, in this study, we assessed the diagnostic accuracy of point-of-care tests for SCD diagnosis in newborns.Aim: To evaluate the sensitivity and specificity of HemotypeSC™ and sickle SCAN ® in diagnosing SCD in newborns.Methods: Diagnostic accuracy of HemotypeSC™ and sickle SCAN ® were evaluated in comparison to isoelectric focusing as a confirmatory method.Results: A total of 706 newborns were enrolled in the study. The sensitivity and specificity of HemotypeSC in detecting Hb SS, Hb AS and Hb AA phonotypes was 100%. The sensitivity and specificity of sickle SCAN ® in detecting Hb SS, Hb AS and Hb AA phenotypes were 100%, 97% and 100% respectively. Conclusion:Both POC tests displayed high accuracy in detecting SCD, we believe the introduction of either of these tests in health facilities will help in the early detection and management of SCD. In addition, the margin of cost per test is relatively affordable (1.

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“…All study participants with malaria were screened for sickle cell hemoglobin. Sickle cell haplotypes were identified as recently published [ 28 ].…”

Section: Methodsmentioning

confidence: 99%

Oxidative stress and associated clinical manifestations in malaria and sickle cell (HbSS) comorbidity

et al. 2022

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In Ghana, uncomplicated malaria and sickle cell disease (SCD) is common, hence comorbidity is not farfetched. However, the extent of oxidative stress and the array of clinical manifestations in this comorbidity (presence of both malaria and SCD) has not been fully explored. This study highlights the impact of uncomplicated malaria on SCD. The level of isoprostane, 8-iso-prostaglandin F2α (8-iso-PGF2α) was used to assess oxidative stress while plasma biochemistry and urinalysis was used to assess renal function. Hematological profiling was also done to assess the impact of comorbidity on the hematological cell lines. Of the 411 study participants with malaria, 45 (11%) had SCD. Mean body temperature was significantly higher in comorbidity compared to malaria and SCD cohorts, while a lower parasite density range was obtained in comorbidity compared to malaria cohorts. Furthermore, in comorbidity, the 8-iso-PGF2α oxidative stress biomarker was significantly elevated in all ages, parasite density ranges and gender groups. Comorbidity affected both leukocytic and erythrocytic cell lines with significant eosinophilia and monocytosis coexisting with erythrocytic parameters consistent with severe anemia. Biochemically, while plasma creatinine and bilirubin were significantly elevated in comorbidity, spot urinary creatinine was significantly reduced. Additionally, urine samples in the comorbid state were slightly acidic and hypersthenuric with significant hematuria, proteinuria, and bilirubinemia. Finally, 80% or more malaria-SCD presented with chills, fever, anorexia, headache, joint pains, lethargy, and vomiting. In conclusion, malaria could induce vaso-occlusive crisis in sickle cell disease, therefore, prompt management will alleviate the severity of this comorbidity.

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Diagnostic Accuracy of HemotypeSC as a Point-of-Care Testing Device for Sickle Cell Disease: Findings from a Southwestern State in Nigeria and Implications for Patient Care in Resource-Poor Settings of sub-Saharan Africa

Cited by 8 publications

References 39 publications

Using dried blood spot on HemoTypeSC™, a new frontier for newborn screening for sickle cell disease in Nigeria

Using dried blood spot on HemoTypeSC™, a new frontier for newborn screening for sickle cell disease in Nigeria

Potential of point of care tests for newborn screening for sickle cell disease: Evaluation of HemotypeSC™ and sickle SCAN® in Tanzania

Oxidative stress and associated clinical manifestations in malaria and sickle cell (HbSS) comorbidity

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