HemoTypeSC Demonstrates &gt;99% Field Accuracy in a Sickle Cell Disease Screening Initiative in Children of Southeastern Uganda

Nankanja, Ruth; Kadhumbula, Sylivester; Tagoola, Abner; Geisberg, Mark; Serrao, Erik; Balyegyusa, Stephen

doi:10.1002/ajh.25458

Cited by 12 publications

(9 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite the high accuracy and other attributes of HemotypeSC in this study and other previous reports, 7 , 8 , 14 , 24 , 25 its use may be impacted by certain factors. Firstly, the test result is counter-intuitive in which case, the presence of a band indicates the absence of that hemoglobin variant.…”

Section: Discussioncontrasting

confidence: 65%

“…However, these variants are scarce in SSA where the high burden of SCD abound. 1 , 2 , 7 , 8 , 24 Furthermore, interpretation of results for individuals with beta-thalassemia may be confusing as sickle-β + -thalassemia is identified as HbAS which will require further testing to classify appropriately. Also, sickle-β ° -thalassemia is identified as HbSS by HemotypeSC however, this misclassification is of little or no clinical significance as both phenotypes have similar disease profiles and are usually clinically indistinguishable and as such, managed similarly.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

Albuquerque

Fagbamigbe

et al. 2021

Global Pediatric Health

View full text Add to dashboard Cite

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.

show abstract

Section: Discussioncontrasting

confidence: 65%

Section: Discussionmentioning

confidence: 99%

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

Albuquerque

Fagbamigbe

et al. 2021

Global Pediatric Health

View full text Add to dashboard Cite

show abstract

“…The crucial role of universal early screening and the potential of POCT methods for SCD in Africa have been noted and discussed in recent years [25][26][27]. Since then, progress has accelerated with at least two POCT products-SickleScan™ (BioMedomics, Morrisville, NC, USA) and HemoTypeSC™ (Silver Lake Research, Azusa, CA, USA)-having been tested in relatively large numbers under field conditions in Africa and having shown high sensitivity and specificity [28][29][30]. Both products are easy to use, require no power or additional materials, can be produced at high volume and low cost, and are capable of screening for SCA and other major SCD-associated genotypes in a few minutes.…”

Section: The Promise Of New Screening Methodsmentioning

confidence: 99%

Caring for Africa’s sickle cell children: will we rise to the challenge?

Oron

Chao

Ezeanolue

et al. 2020

BMC Med

View full text Add to dashboard Cite

Background Most of the world’s sickle cell disease (SCD) burden is in Africa, where it is a major contributor to child morbidity and mortality. Despite the low cost of many preventive SCD interventions, insufficient resources have been allocated, and progress in alleviating the SCD burden has lagged behind other public-health efforts in Africa. The recent announcement of massive new funding for research into curative SCD therapies is encouraging in the long term, but over the next few decades, it is unlikely to help Africa’s SCD children substantially. Main discussion A major barrier to progress has been the absence of large-scale early-life screening. Most SCD deaths in Africa probably occur before cases are even diagnosed. In the last few years, novel inexpensive SCD point-of-care test kits have become widely available and have been deployed successfully in African field settings. These kits could potentially enable universal early SCD screening. Other recent developments are the expansion of the pneumococcal conjugate vaccine towards near-universal coverage, and the demonstrated safety, efficacy, and increasing availability and affordability of hydroxyurea across the continent. Most elements of standard healthcare for SCD children that are already proven to work in the West, could and should now be implemented at scale in Africa. National and continental SCD research and care networks in Africa have also made substantial progress, assembling care guidelines and enabling the deployment and scale-up of SCD public-health systems. Substantial logistical, cultural, and awareness barriers remain, but with sufficient financial and political will, similar barriers have already been overcome in efforts to control other diseases in Africa. Conclusion and recommendations Despite remaining challenges, several high-SCD-burden African countries have the political will and infrastructure for the rapid implementation and scale-up of comprehensive SCD childcare programs. A globally funded effort starting with these countries and expanding elsewhere in Africa and to other high-burden countries, including India, could transform the lives of SCD children worldwide and help countries to attain their Sustainable Development Goals. This endeavor would also require ongoing research focused on the unique needs and challenges of SCD patients, and children in particular, in regions of high prevalence.

show abstract

“…Two samples with HbSS phenotype were missed and identified as HbAS. It was found that both patients had blood transfusions recently [ 82 ]. HemoTypeSC was tested in Côte D’Ivoire by analyzing 336 children: 100 children already diagnosed with hemoglobin disease and 236 as participants.…”

Section: Innovative Techniques For the Diagnosis And Monitoring Of Scdmentioning

confidence: 99%

Techniques for the Detection of Sickle Cell Disease: A Review

2021

View full text Add to dashboard Cite

Sickle cell disease (SCD) is a widespread disease caused by a mutation in the beta-globin gene that leads to the production of abnormal hemoglobin called hemoglobin S. The inheritance of the mutation could be homozygous or heterozygous combined with another hemoglobin mutation. SCD can be characterized by the presence of dense, sickled cells that causes hemolysis of blood cells, anemia, painful episodes, organ damage, and in some cases death. Early detection of SCD can help to reduce the mortality and manage the disease effectively. Therefore, different techniques have been developed to detect the sickle cell disease and the carrier states with high sensitivity and specificity. These techniques can be screening tests such as complete blood count, peripheral blood smears, and sickling test; confirmatory tests such as hemoglobin separation techniques; and genetic tests, which are more expensive and need to be done in centralized labs by highly skilled personnel. However, advanced portable point of care techniques have been developed to provide a low-cost, simple, and user-friendly device for detecting SCD, for instance coupling solubility tests with portable devices, using smartphone microscopic classifications, image processing techniques, rapid immunoassays, and sensor-based platforms. This review provides an overview of the current and emerging techniques for sickle cell disease detection and highlights the different potential methods that could be applied to help the early diagnosis of SCD.

show abstract

HemoTypeSC Demonstrates >99% Field Accuracy in a Sickle Cell Disease Screening Initiative in Children of Southeastern Uganda

Cited by 12 publications

References 5 publications

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

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

Caring for Africa’s sickle cell children: will we rise to the challenge?

Techniques for the Detection of Sickle Cell Disease: A Review

Contact Info

Product

Resources

About