Point-of-care diagnostic tests for sickle cell disease

Kawooya, Ismael; Kayongo, Edward; Munube, Deogratias; Mijumbi-Deve, Rhona; Elliott, Sarah A.; Vandermeer, Ben; Sewankambo, Nelson

doi:10.1002/14651858.cd014584

Cited by 3 publications

(5 citation statements)

References 42 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, novel technologies for point-of-care testing are on the horizon and these may overcome the limitations of the SCST by offering more accurate and rapid diagnosis. Various new technologies have been developed including paper-based hemoglobin solubility, lateral flow immunoassays, micro-engineered HE, density-based separation, and smartphone-based application tests [ 57 ]. Of these, the lateral flow immunoassays have gained the most traction in resource-poor settings.…”

Section: Future Directions Beyond the Solubility Testmentioning

confidence: 99%

“…These assays rely on the formation antibody-antigen complexes between commercially available antibodies and patient supplied antigens (hemoglobin), and thus can distinguish between SCD and SCT [ 58 ]. The Sickle SCAN ® uses polyclonal antibody targets against HbA, HbS and hemoglobin C (HbC) to identify the hemoglobin type, with a positive test indicated by a line next to the corresponding hemoglobin type [ 57 , 58 ]. In comparison, the HemoTypeSC ® utilizes monoclonal antibodies against HbA, HbS and HbC on fixed test lines, with a positive result indicated by the absence of a line next to the hemoglobin type [ 57 , 58 ].…”

Section: Future Directions Beyond the Solubility Testmentioning

confidence: 99%

“…The Sickle SCAN ® uses polyclonal antibody targets against HbA, HbS and hemoglobin C (HbC) to identify the hemoglobin type, with a positive test indicated by a line next to the corresponding hemoglobin type [ 57 , 58 ]. In comparison, the HemoTypeSC ® utilizes monoclonal antibodies against HbA, HbS and HbC on fixed test lines, with a positive result indicated by the absence of a line next to the hemoglobin type [ 57 , 58 ]. Both tests can be performed on infants with high HbF and are inexpensive (less than $5) [ 58 ].…”

Section: Future Directions Beyond the Solubility Testmentioning

confidence: 99%

See 2 more Smart Citations

Sickle Cell Screening in Adults: A Current Review of Point-of-Care Testing

Mendez-Marti,

Zik,

Alan

et al. 2024

J Hematol

View full text Add to dashboard Cite

In adults, the sickle cell solubility test (SCST) is the most common screening test to determine the presence of hemoglobin S (HbS) within a blood sample. The assay is inexpensive, rapid, highly sensitive and specific. However, the SCST cannot accurately quantify the level of HbS in a test sample and requires confirmatory testing to distinguish between sickle trait and sickle cell disease. Despite these limitations, it remains the standard screening tool for HbS in a variety of settings such as screening in the US military or by the National Collegiate Athletic Association. With an increased awareness of the importance of screening for sickle cell in adults, we herein describe the current sensitivity, specificity, positive predictive value, and negative predictive value of this test. We also review overall clinical utility of this laboratory measure and briefly discuss new point-of-care techniques designed to overcome the SCST’s shortcomings.

show abstract

Section: Future Directions Beyond the Solubility Testmentioning

confidence: 99%

Section: Future Directions Beyond the Solubility Testmentioning

confidence: 99%

Section: Future Directions Beyond the Solubility Testmentioning

confidence: 99%

See 1 more Smart Citation

Sickle Cell Screening in Adults: A Current Review of Point-of-Care Testing

Mendez-Marti,

Zik,

Alan

et al. 2024

J Hematol

View full text Add to dashboard Cite

show abstract

“…This test relies on often unaffordable (USD 15 k-35 k or GHS 90 k-210 k) specialized instruments, state-of-the-art laboratory facilities, and highly trained personnel, which are lacking in the low-resource settings where β-Thal is most prevalent [2]. As a result, there is a need for affordable, portable, easy-to-use, and accurate point-of-care (POC) tests to facilitate decentralized β-Thal testing in low-resource settings [15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

“…Several POC diagnostic systems for several hemoglobin variants such as Hb S have been described [15][16][17][18][19][20][21] based on testing methods such as the sickle cell solubility test and antibody-based lateral flow assays such as Sickle SCAN TM and HemoType SC TM [22][23][24]. However, there is currently no POC test available for β-Thal detection.…”

Section: Introductionmentioning

confidence: 99%

Point-of-Care Diagnostic Test for Beta-Thalassemia

An,

Avanaki,

Thota

et al. 2024

Biosensors

View full text Add to dashboard Cite

Hemoglobin (Hb) disorders are among the most common monogenic diseases affecting nearly 7% of the world population. Among various Hb disorders, approximately 1.5% of the world population carries β-thalassemia (β-Thal), affecting 40,000 newborns every year. Early screening and a timely diagnosis are essential for β-thalassemia patients for the prevention and management of later clinical complications. However, in Africa, Southern Europe, the Middle East, and Southeast Asia, where β-thalassemia is most prevalent, the diagnosis and screening for β-thalassemia are still challenging due to the cost and logistical burden of laboratory diagnostic tests. Here, we present Gazelle, which is a paper-based microchip electrophoresis platform that enables the first point-of-care diagnostic test for β-thalassemia. We evaluated the accuracy of Gazelle for the β-Thal screening across 372 subjects in the age range of 4–63 years at Apple Diagnostics lab in Mumbai, India. Additionally, 30 blood samples were prepared to mimic β-Thal intermediate and β-Thal major samples. Gazelle-detected levels of Hb A, Hb F, and Hb A2 demonstrated high levels of correlation with the results reported through laboratory gold standard high-performance liquid chromatography (HPLC), yielding a Pearson correlation coefficient = 0.99. This ability to obtain rapid and accurate results suggests that Gazelle may be suitable for the large-scale screening and diagnosis of β-Thal.

show abstract

Evaluating the performance of ErbaQik sickle cell rapid test card with HPLC method

Lalla,

Rughwani,

Chugh

2024

IJRIMCR

View full text Add to dashboard Cite

Sickle cell disease (SCD) is a hereditary hemoglobinopathy characterized by the presence of abnormal hemoglobin, primarily hemoglobin S (HbS), resulting from a point mutation in the β-globin gene. ErbaQik Sickle Cell Rapid Test Card developed by Transasia Diagnostics Pvt Ltd will aid in rapid detection of Sickle cell disease particularly in resource & laboratory infrastructure limited settings.To ensure the accuracy of ErbaQik Sickle Cell Rapid Test Card, a robust validation was conducted and compared with gold standard HPLC method to check the sensitivity, specificity, precision and clinical utility. This study was conducted under the guidance of Consultant Paediatrician, from Dec 2023 to Feb 2024 at Nagpur center run by Thalassemia and Sickle cell Society of India in collaboration with Rughwani Child Care Centre to evaluate the performance of ErbaQik Sickle Cell Rapid Test Card with HPLC method which is the benchmark for comparison in this study. A total of 181 blood samples were analyzed for hemoglobin variants. The evaluation of the ErbaQik Sickle Cell Rapid Test Card produced significant findings For Sickle-SS 32 samples were tested, all of which were correctly identified, yielding a sensitivity and specificity of 100%. Similarly 27 Trait-AS samples were all accurately detected, maintaining 100% sensitivity and specificity. These results indicate the test's high reliability and precision in identifying Sickle Cell Disease and Trait conditions. For Wild-Normal samples, the test was performed on 120 samples resulting in 100% sensitivity and specificity. In the case of Thalassemia samples, only 2 samples were tested, with 1 correctly identified, resulting in a sensitivity and specificity of 50%. The ErbaQik Sickle Cell Rapid Test Card demonstrated high sensitivity and specificity for detecting Sickle Cell Disease (SS) and Trait (AS), aligning with gold-standard methods like HPLC.

show abstract

Point-of-care diagnostic tests for sickle cell disease

Cited by 3 publications

References 42 publications

Sickle Cell Screening in Adults: A Current Review of Point-of-Care Testing

Sickle Cell Screening in Adults: A Current Review of Point-of-Care Testing

Point-of-Care Diagnostic Test for Beta-Thalassemia

Evaluating the performance of ErbaQik sickle cell rapid test card with HPLC method

Contact Info

Product

Resources

About