Evidence map›Paper›PMID 30290004›Full record

Trial reportAmerican journal of hematology2019

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

Cindy Steele, Annette Sinski, Jacqueline Asibey, Marie-Dominique Hardy-Dessources, Gisèle Elana, Colleen Brennan, Isaac Odame, Carolyn Hoppe, Mark Geisberg, Erik Serrao and 1 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 6 countries.

Cindy SteeleOperation International Kids, Southampton, New York.
Annette SinskiOperation International Kids, Southampton, New York.
Jacqueline AsibeyHoly Family Hospital, Techiman, Ghana.
Marie-Dominique Hardy-DessourcesInserm UMR 1134, Hôpital Ricou, Pointe-à-Pitre, Guadeloupe.
Gisèle ElanaReferral Center for Sickle Cell Disease, Department of Pediatrics, University Hospital of Martinique, Martinique.
Colleen BrennanOperation International Kids, Southampton, New York.
Isaac OdameThe Hospital for Sick Children, Department of Paediatrics, University of Toronto, Toronto, Canada.
Carolyn HoppeDepartment of Hematology-Oncology, UCSF Benioff Children's Hospital Oakland, Oakland, California.
Mark GeisbergSilver Lake Research Corporation, Azusa, California.
Erik SerraoSilver Lake Research Corporation, Azusa, California.
Charles T QuinnDivision of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.ORCID 0000-0002-2372-2175
Southampton Hospital · USSilver Lake Research (United States) · USCentre Hospitalier Universitaire Pointe-à-Pitre · GPCincinnati Children's Hospital Medical Center · USHoly Family Hospital · GHMartin University · USUCSF Benioff Children's Hospital · USUniversity of Toronto · CA

Funding

Rapid LFIA blood test for SCD using highly specific monoclonal antibodiesR44HL123670 · NHLBI · SILVER LAKE RESEARCH CORPORATION · PI GEISBERG, MARK · 2016 to 2017
$1.0M
Rapid LFIA blood test for SCD using highly specific monoclonal antibodiesR43HL123670 · NHLBI · SILVER LAKE RESEARCH CORPORATION · PI GEISBERG, MARK · 2014 to 2015
$443k
NHLBI NIH HHS R43 HL123670NHLBI NIH HHS R44 HL123670
6 · The paper itself

Abstract

Sickle cell disease (SCD) is a common, life-threatening genetic disorder that is best managed when diagnosed early by newborn screening. However, SCD is most prevalent in low-resource regions of the world where newborn screening is rare and diagnosis at the point-of-care is challenging. In many such regions, the majority of affected children die, undiagnosed, before the age of 5 years. A rapid and affordable point-of-care test for SCD is needed. The diagnostic accuracy of HemoTypeSC, a point-of-care immunoassay, for SCD was evaluated in individuals who had SCD, hemoglobin C disease, the related carrier (trait) states, or a normal hemoglobin phenotype. Children and adults participated in low-, medium- and high-resource environments (Ghana [n = 383], Martinique [n = 46], and USA [n = 158]). Paired blood specimens were obtained for HemoTypeSC and a reference diagnostic assay. HemoTypeSC testing was performed at the site of blood collection, and the reference test was performed in a laboratory at each site. In 587 participants, across all study sites, HemoTypeSC had an overall sensitivity of 99.5% and specificity of 99.9% across all hemoglobin phenotypes. The test had 100% sensitivity and specificity for sickle cell anemia. Sensitivity and specificity for detection of normal and trait states were >99%. HemoTypeSC is an inexpensive (<$2 per test), accurate, and rapid point-of-care test that can be used in resource-limited regions with a high prevalence of SCD to provide timely diagnosis and support newborn screening programs.

Indexed as

ImmunoassayPoint-of-Care SystemsAdultAnemia, Sickle CellAntibodies, MonoclonalChildDeveloping CountriesEarly DiagnosisFemaleGhanaHemoglobin AHemoglobin CHemoglobin C DiseaseHemoglobin, SickleHumansInfant, NewbornAntibodies, MonoclonalHemoglobin AHemoglobin CHemoglobin, Sickle

Identifiers

PMID30290004
PMCPMC6298816
OpenAlexW2895436157

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.