Validation of a Low-Cost Paper-Based Screening Test for Sickle Cell Anemia

Piety, Nathaniel Z.; Yang, Xiaoxi; Kanter, Julie; Vignes, Seth M.; George, Alex; Shevkoplyas, Sergey S.

doi:10.1371/journal.pone.0144901

Cited by 37 publications

(42 citation statements)

References 39 publications

(54 reference statements)

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“…While these represent significant advances in diagnostic capabilities for SCD, each has deficiencies. Each method requires an instrument as either an integral part of the procedure or to achieve maximum sensitivity and specificity (Piety et al , 2016; McGann et al , 2016), which can be prohibitive in low-resource settings. In addition, none of these methods achieve 100% accuracy with or without instrumentation.…”

Section: Introductionmentioning

confidence: 99%

A rapid, inexpensive and disposable point‐of‐care blood test for sickle cell disease using novel, highly specific monoclonal antibodies

et al. 2016

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Summary Sickle cell disease (SCD) is a significant healthcare burden worldwide, but most affected individuals reside in low-resource areas where access to diagnostic testing may be limited. We developed and validated a rapid, inexpensive, disposable diagnostic test, the HemoTypeSC™, based on novel monoclonal antibodies (MAbs) that differentiate normal adult haemoglobin (Hb A), sickle haemoglobin (Hb S) and haemoglobin C (Hb C). In competitive enzyme-linked immunosorbent assays, each MAb bound only its target with <0.1% cross-reactivity. With the HemoTypeSC™ test procedure, the sensitivity for each variant was <5.0 g/l. The accuracy of HemoTypeSC™ was evaluated on 100 whole blood samples from individuals with common relevant haemoglobin phenotypes, including normal (Hb AA, N=20), carrier or trait (Hb AS, N=22; Hb AC, N=20), SCD (Hb SS, N=22; Hb SC, N=13), and Hb C disease (Hb CC, N=3). The correct haemoglobin phenotype was identified in 100% of these samples. The accuracy of the test was not affected by Hb F (0-94.8% of total Hb) or Hb A2 (0-5.6% of total Hb). HemoTypeSC™ requires <1 μl of whole blood and no instruments or power sources. The total time-to-result is <20 min. HemoTypeSC™ may be a practical solution for point-of-care testing for SCD and carrier status in low-resource settings.

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Section: Introductionmentioning

confidence: 99%

A rapid, inexpensive and disposable point‐of‐care blood test for sickle cell disease using novel, highly specific monoclonal antibodies

et al. 2016

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“…In addition, the test relies on naked-eye detection which may render it prone to operator error, which can be overcome by pairing the test with an automated image processing algorithm. Moreover, the validation results show that this test cannot accurately distinguish between HbSC and HbAS even when used with automated image processing 179, 180 . Finally, high levels of HbF, especially present in newborns, prevent the polymerization and precipitation of HbS, and consequently hinder the application of the test to newborn screening 171 .…”

Section: Scd Screening At the Pocmentioning

confidence: 99%

“…These patterns are used to differentiate between HbAA, HbAS and HbSS, and the test process can be completed within 20 minutes 177–180 . Initial validation results of this test in a resource-limited setting showed that HbS can be visually identified with 94.2 % sensitivity and 97.7 % 180 . Furthermore, when combined with a custom image analysis algorithm, the relative color intensity of the center spot can be used to quantify Hb concentration in the sample.…”

Section: Scd Screening At the Pocmentioning

confidence: 99%

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Emerging point-of-care technologies for sickle cell disease screening and monitoring

Alapan

Fraiwan

Kucukal

et al. 2016

Expert Review of Medical Devices

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Introduction Sickle Cell Disease (SCD) affects 100,000 Americans and more than 14 million people globally, mostly in economically disadvantaged populations, requires early diagnosis after birth and constant monitoring throughout the life-span of the patient. Areas Covered Early diagnosis of SCD still remains a challenge in preventing childhood mortality in the developing world due to requirements of skilled personnel and high-cost of currently available modalities. On the other hand, SCD monitoring presents insurmountable challenges due to heterogeneities among patient populations, as well as in the same individual longitudinally. Here, we describe emerging point-of-care micro/nano platform technologies for SCD screening and monitoring, and critically discuss current state-of-the-art, potential challenges associated with these technologies, and future directions. Expert Commentary Recently developed microtechnologies offer simple, rapid, and affordable screening of SCD and have the potential to facilitate universal screening in resource-limited settings and developing countries. On the other hand, monitoring of SCD is more complicated compared to diagnosis and requires comprehensive validation of efficacy. Early use of novel microdevices for patient monitoring might come in especially handy in new clinical trial designs of emerging therapies.

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“…Entretanto, o teste é ideal para crianças maiores que 1 ano, uma vez que abaixo dessa idade ainda há grande quantidade de HbF e o teste é incapaz de detectar HbS em pequena quantidade (PIETY et al, 2016 A anemia falciforme é uma doença que não tem tratamento específico, existem apenas medidas gerais e preventivas, através de avaliações clinicas e laboratoriais periódicas, com a finalidade de melhorar a qualidade de vida dos pacientes e aumentar a sobrevida. A rotina de acompanhamento clínico inicia antes dos dois meses de vida através de orientações para os pais a respeito de intervenções capazes de minimizar as manifestações clínicas, como manter hidratação e nutrição adequadas, reconhecer sinais de palidez, realizar vacinações (pneumocócica conjugada 7-valente, meningococo C, vírus influenza e todas as outras do calendário vacinal), manter uso da penicilina profilática e higienização oral adequada (BRAGA, 2007).…”

Section: Reas Revista Eletrônicaunclassified

Anemia falciforme: uma revisão acerca da doença, novos métodos diagnósticos e tratamento

Barros¹,

Assunção²,

Santos³

2017

REAS

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RESUMOObjetivo: essa pesquisa teve como objetivo fazer uma revisão da literatura atual sobre a anemia falciforme, novos métodos diagnósticos e tratamento. Métodos: por meio da base de dados, foram pesquisados artigos da literatura médica da língua inglesa e portuguesa, de janeiro de 1996 a outubro de 2016, que se concentraram em oferecer um panorama acerca da anemia falciforme e dos testes diagnóstico. Resultados: como resultado, foi possível comparar as formas de diagnósticos já existentes e os novos testes rápidos, descartáveis, de baixo custo, que vem sendo desenvolvidos e sua importância em regiões carentes para um diagnóstico precoce e início do tratamento. Conclusão: a vantagem dessas inovações é que não necessita do uso de mão de obra especializada, o que torna mais adequado à realidade das nações subdesenvolvidas.Palavras-chave: Anemia falciforme; Novos Métodos; Diagnóstico; Países Subdesenvolvidos. ABSTRACTObjective: this research aimed to review the current literature on sickle cell anemia, new diagnostic methods and treatment. Method: through the database, articles from the English and Portuguese medical literature were searched from January 1996 to October 2016, which focused on providing an overview of sickle cell anemia and diagnostic tests. Result: as a result, it was possible to compare the existing diagnostic forms and the new low-cost, fast tests that have been developed and its importance in poor regions for early diagnosis and early treatment. Conclusion: the advantage of these innovations is that they do not require the use of specialized workers, which makes them more suited to the reality of underdeveloped nations.Key word: Sickle Cell Anemia. News Methods; Diagnostic; Underdeveloped Countries. RESUMENObjetivo: este studio tuvo como objetivo revisar la literature disponible sobre la enfermedad de células falciformes, nuevos métodos de diagnóstico y tratamiento. Métodos: por medio de la base de datos, fueron investigados artículos de la literatura médica de la lengua inglesa y portuguesa, de enero de 1996 a octubre de 2016, que se concentraron en ofrecer un panorama sobre la anemia falciforme y las pruebas diagnósticas. Resultados: como resultado, fue possible comparar las formas existentes de diagnóstico y nuevas pruebas desechables rápidos, de bajo costo, que está siendo desarrollado y su importancia en regiones carentes para un diagnóstico precoz e inicio del tratamiento. Conclusión: la ventaja de estas innovaciones es que no requieran un uso especializado de trabajo, lo que hace que se a más adecuado a la realidad de los países subdesarrollados.

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Validation of a Low-Cost Paper-Based Screening Test for Sickle Cell Anemia

Cited by 37 publications

References 39 publications

A rapid, inexpensive and disposable point‐of‐care blood test for sickle cell disease using novel, highly specific monoclonal antibodies

A rapid, inexpensive and disposable point‐of‐care blood test for sickle cell disease using novel, highly specific monoclonal antibodies

Emerging point-of-care technologies for sickle cell disease screening and monitoring

Anemia falciforme: uma revisão acerca da doença, novos métodos diagnósticos e tratamento

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