Evidence map›Paper›PMID 26377572›Full record

ArticleBMC medicine2015

Validation of a novel point of care testing device for sickle cell disease.

Julie Kanter, Marilyn J Telen, Carolyn Hoppe, Christopher L Roberts, Jason S Kim, Xiaoxi Yang

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07009821 (SCREENING EmoCamp_ Analysis of Major Haemoglobinopathies Among Newborns in the Campania Region), which is not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT07009821 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

SCREENING EmoCamp_ Analysis of Major Haemoglobinopathies Among Newborns in the Campania Region

TypeobservationalSponsorMaddalena CasaleRan2025 to 2027Enrolled1,000ConditionsSCD
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 1 synthesis or guideline pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Diagnostic accuracy of the sickle SCANAnnals of hematology · 2026
    Article
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  6. Review
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  12. Article
  13. Newborn screening initiatives for sickle cell disease in Africa.Hematology. American Society of Hematology. Education Program · 2024
    Review
  14. Article
  15. Article
  16. Article
  17. Review
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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

6 authors at 3 institutions in 1 country.

Julie KanterPediatrics, Medical University of South Carolina, Charleston, SC, USA. kanter@musc.edu.
Marilyn J TelenDivision of Hematology, Department of Medicine, Duke University Medical Center, Durham, NC, 27710, USA.
Carolyn HoppeChildren's Hospital Oakland, Oakland, CA, 94609, USA.
Christopher L RobertsBioMedomics, Inc., Durham, NC, USA.
Jason S KimBioMedomics, Inc., Durham, NC, USA.
Xiaoxi YangBioMedomics, Inc., Durham, NC, USA.
BioMedomics (United States) · USDuke Medical Center · USMedical University of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSickle cell disease is one of the most common inherited blood disorders. Universal screening and early intervention have significantly helped to reduce childhood mortality in high-resource countries. However, persons living in low-resource settings are often not diagnosed until late childhood when they present with clinical symptoms. In addition, confirmation of disease in affected individuals in the urgent care setting is limited in both high- and low-resource areas, often leading to delay in treatment. All of the current diagnostic methods rely on advanced laboratory systems and are often prohibitively expensive and time-consuming in low-resource settings. To address this need, the Sickle SCAN™ test has been developed to diagnose sickle cell disease and sickle cell trait at the point of care without electricity or advanced equipment.

methodsThis study was conducted to evaluate and validate the diagnostic accuracy of the Sickle SCAN™ test, a novel point of care test for sickle cell disease. Thus, we describe the laboratory testing and clinical validation of the Sickle SCAN™ test in individuals >1 year of age using capillary blood. The Sickle SCAN™ test was created using advanced, qualitative lateral flow technology using capillary blood to identify the presence of hemoglobin A, S, and C allowing for detection of results with the naked eye.

resultsLaboratory testing using venous blood demonstrated 99 % sensitivity and 99 % specificity for the diagnosis of HbSS, HbAS, HbSC, HbAC, and HbAA. Seventy-one subjects underwent capillary blood sampling at the point of care for further validation. This test detected the correct A, S, and C presence with an overall diagnostic accuracy of 99 % at the bedside.

conclusionThe Sickle SCAN™ test has the potential to significantly impact the diagnosis and treatment for sickle cell disease worldwide as well as enhance genetic counseling at the point of care. Further validation testing will be conducted in newborns in resource-poor settings in upcoming studies.

Indexed as

Point-of-Care TestingAdultAnemia, Sickle CellFemaleHumansInfant, NewbornMaleMiddle AgedSensitivity and Specificity

Identifiers

PMID26377572
PMCPMC4573998
OpenAlexW2161448604

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.