scholarly journals Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test

2018 ◽  
Vol 94 (1) ◽  
pp. 39-45 ◽  
Author(s):  
Cindy Steele ◽  
Annette Sinski ◽  
Jacqueline Asibey ◽  
Marie-Dominique Hardy-Dessources ◽  
Gisèle Elana ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Point Of Care ◽  
Rapid Test ◽  
Cell Disease ◽  
Low Resource Settings ◽  
Low Resource

scholarly journals End points for sickle cell disease clinical trials: renal and cardiopulmonary, cure, and low-resource settings

2019 ◽  
Vol 3 (23) ◽  
pp. 4002-4020 ◽  
Author(s):  
Ann T. Farrell ◽  
Julie Panepinto ◽  
Ankit A. Desai ◽  
Adetola A. Kassim ◽  
Jeffrey Lebensburger ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Patient Reported Outcome ◽  
Cell Disease ◽  
End Points ◽  
Low Resource Settings ◽  
Low Resource ◽  
Patient Reported ◽  
The Us ◽  
American Society

Abstract To address the global burden of sickle cell disease and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to patient-reported outcome, pain (non–patient-reported outcomes), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the end-organ considerations, measurement of cure, and low-resource settings panels as well as relevant findings and recommendations from the biomarkers panel.

scholarly journals Allele-Specific Recombinase Polymerase Amplification to Detect Sickle Cell Disease in Low-Resource Settings

2021 ◽  
Vol 93 (11) ◽  
pp. 4832-4840
Author(s):  
Mary E. Natoli ◽  
Megan M. Chang ◽  
Kathryn A. Kundrod ◽  
Jackson B. Coole ◽  
Gladstone E. Airewele ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Recombinase Polymerase Amplification ◽  
Cell Disease ◽  
Low Resource Settings ◽  
Low Resource ◽  
Allele Specific

Preliminary Evaluation of a Point-of-Care Testing Device (SickleSCAN™) in Screening for Sickle Cell Disease

Hemoglobin ◽  
2017 ◽  
Vol 41 (2) ◽  
pp. 77-82 ◽  
Author(s):  
Maxwell M. Nwegbu ◽  
Hezekiah A. Isa ◽  
Biyaya B. Nwankwo ◽  
Chinedu C. Okeke ◽  
Uduak J. Edet-Offong ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Point Of Care ◽  
Preliminary Evaluation ◽  
Testing Device ◽  
Cell Disease ◽  
Point Of Care Testing

Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India

2019 ◽  
Vol 153 (1) ◽  
pp. 82-87 ◽  
Author(s):  
Malay B Mukherjee ◽  
Roshan B Colah ◽  
Pallavi R Mehta ◽  
Nikhil Shinde ◽  
Dipty Jain ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Newborn Screening ◽  
Sickle Cell ◽  
High Performance ◽  
Screening Program ◽  
Point Of Care ◽  
Genetic Disorder ◽  
Cell Disease ◽  
Point Of Care Test ◽  
Tribal Areas

Abstract Objectives Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a rapid and affordable point-of-care test for sickle cell disease is needed. Methods The diagnostic accuracy of HemoTypeSC was evaluated against automated high-performance liquid chromatography (HPLC) as the gold standard for its efficacy in a newborn screening program. Results A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed by both methods. HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas. Conclusions We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype.

scholarly journals Newborn Screening for Sickle Cell Disease Using Point-of-Care Testing in Low-Income Setting

PEDIATRICS ◽  
2019 ◽  
Vol 144 (4) ◽  
pp. e20184105 ◽  
Author(s):  
Ofelia A. Alvarez ◽  
Tally Hustace ◽  
Mimose Voltaire ◽  
Alejandro Mantero ◽  
Ulrick Liberus ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Newborn Screening ◽  
Sickle Cell ◽  
Low Income ◽  
Point Of Care ◽  
Cell Disease ◽  
Point Of Care Testing ◽  
Low Income Setting

Accuracy of Point-of-care Lung Ultrasonography for Diagnosis of Acute Chest Syndrome in Pediatric Patients with Sickle Cell Disease and Fever

2016 ◽  
Vol 23 (8) ◽  
pp. 932-940 ◽  
Author(s):  
Dina D. Daswani ◽  
Vaishali P. Shah ◽  
Jeffrey R. Avner ◽  
Deepa G. Manwani ◽  
Jessica Kurian ◽  
...  
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Pediatric Patients ◽  
Point Of Care ◽  
Acute Chest Syndrome ◽  
Lung Ultrasonography ◽  
Cell Disease

scholarly journals Point-of-Care Screening for Sickle Cell Disease By a Mobile Micro-Electrophoresis Platform

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3379-3379 ◽  
Author(s):  
Ryan Ung ◽  
Yunus Alapan ◽  
Muhammad Noman Hasan ◽  
Megan Romelfanger ◽  
Ping He ◽  
...  
Keyword(s):  
Image Processing ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Operating Characteristic ◽  
Point Of Care ◽  
Cell Disease ◽  
Web Based ◽  
Processing Application ◽  
Image Processing Application ◽  
Objective Quantification

Abstract In developing countries, diagnostic tests for homozygous (HbSS) or compound heterozygous (HbSC or HbS-Beta thalassemia) sickle cell disease (SCD) are not readily available at the point-of-care (POC). Very few infants are screened in Africa for SCD because of the high cost and level of skill needed to run traditional tests. Current methods are too costly and take too much time to enable equitable and timely diagnosis to save lives. The World Health Organization recognizes a crucial need for early detection of SCD in newborns, since it is estimated that 70% SCD-related deaths in Africa are preventable with early cost-effective interventions. The diagnostic barrier can be broken with affordable, POC tools that facilitate early detection immediately after birth. We have developed a mobile micro-electrophoretic device (HemeChip) through which to quickly, accurately, and affordably screen for SCD (Fig. 1A). The HemeChip uses a microfabricated platform housing cellulose acetate electrophoresis to rapidly separate hemoglobin (Hb) types. Less than 5 microliters of blood, which can be obtained through a finger stick or heel stick, is processed on a piece of cellulose paper in alkaline buffer. The HemeChip reliably identifies and discriminates amongst Hb C/A2, S, F and A0. The micro-electrophoresis results were validated against standard clinical hemoglobin screening methods, including high performance liquid chromatography (HPLC), with Pearson Correlation Coefficient (PCC) of ≥0.96 relative to HPLC for all Hb types tested. The receiver Operating-Characteristic (ROC) curves showed more than 0.89 sensitivity and 0.86 specificity for identification of hemoglobin types using the HemeChip, based on the travelling distance from the sample application point (Fig. 1B). We developed a web-based image processing application for automated and objective quantification of HemeChip results at the POC using cloud computing resources (Fig. 1C). This intensity-based mobile phone image quantitation method showed high correlation with HPLC results for tested patient blood samples (PCC=0.95). HemeChip can distinguish between different patient phenotypes, including HbSS (HbS only), transfused HbSS (HbS and HbA), and Hemoglobin SC disease (HbS and HbC). In conclusion, the HemeChip identification and quantification of hemoglobin phenotypes, as a POC technique, were comparable to standard clinical methods. This platform has clinical potential in under-served populations worldwide, in which SCD is endemic. Figure 1. Mobile micro-electrophoretic device (HemeChip) for point-of-care screening for sickle cell disease. ( A) HemeChip prototype is shown with a miniscule blood sample that has been separated into characteristic hemoglobin bands. (B) The receiver Operating-Characteristic (ROC) curves show sensitivity and specificity of HemeChip for differentiating between adjacent hemoglobin bands based on the travelling distance from the sample application point. band traveling distance thresholds are shown: circle=7.5 mm, triangle=10.0 mm, and square=12.5 mm. (C) Web-based image processing application for automated and objective quantification of HemeChip results at the POC using cloud computing resources. Figure 1. Mobile micro-electrophoretic device (HemeChip) for point-of-care screening for sickle cell disease. ( A) HemeChip prototype is shown with a miniscule blood sample that has been separated into characteristic hemoglobin bands. (B) The receiver Operating-Characteristic (ROC) curves show sensitivity and specificity of HemeChip for differentiating between adjacent hemoglobin bands based on the travelling distance from the sample application point. band traveling distance thresholds are shown: circle=7.5 mm, triangle=10.0 mm, and square=12.5 mm. (C) Web-based image processing application for automated and objective quantification of HemeChip results at the POC using cloud computing resources. Disclosures No relevant conflicts of interest to declare.

scholarly journals Smartphone-based Sickle Cell Disease Detection and Monitoring for Point-of-Care Settings

2020 ◽  
Author(s):  
Shazia Ilyas ◽  
Mazhar Sher ◽  
E Du ◽  
Waseem Asghar
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Early Stage ◽  
Point Of Care ◽  
Unmet Need ◽  
Optical Microscope ◽  
Diagnostic Methods ◽  
Sub Saharan Africa ◽  
Cell Disease ◽  
Resource Limited

AbstractSickle cell disease (SCD) is a worldwide hematological disorder causing painful episodes, anemia, organ damage, stroke, and even deaths. It is more common in sub-Saharan Africa and other resource-limited countries. Conventional laboratory-based diagnostic methods for SCD are time-consuming, complex, and cannot be performed at point-of-care (POC) and home settings. Optical microscope-based classification and counting demands a significant amount of time, extensive setup, and cost along with the skilled human labor to distinguish the normal red blood cells (RBCs) from sickled cells. There is an unmet need to develop a POC and home-based test to diagnose and monitor SCD and reduce mortality in resource-limited settings. An early-stage and timely diagnosis of SCD can help in the effective management of the disease. In this article, we utilized a smartphone-based image acquisition method for capturing RBC images from the SCD patients in normoxia and hypoxia conditions. A computer algorithm is developed to differentiate RBCs from the patient’s blood before and after cell sickling. Using the developed smartphone-based technique, we obtained similar percentage of sickle cells in blood samples as analyzed by conventional method (standard microscope). The developed method of testing demonstrates the potential utility of the smartphone-based test for reducing the overall cost of screening and management for SCD, thus increasing the practicality of smartphone-based screening technique for SCD in low-resource settings. Our setup does not require any special storage requirements and is particularly useful in assessing the severity of the SCD. This is the characteristic advantage of our technique as compared to other hemoglobin-based POC diagnostic techniques.

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