Evidence map›Paper›PMID 41296576›Full record

ArticleThe Indian journal of medical research2025

Diagnostic accuracy of HemoTypeSC for detecting sickle cell disease in newborns: A multicentric study.

Pallavi Thaker, Nikhil Shinde, Suchitra Surve, Kalpita Gawit, Priya Hariharan, Rajasubramanium Shanmugam, Anna Salomi Kerketta, Manoranjan Ranjit, Kapilkumar Dave, Mahendra Thakor and 6 more

Abstract readMulticenter Study
In one paragraph

Article in The Indian journal of medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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1citing papers in PubMed
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1 · What the graph read from it

What it found

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2 · The registry

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

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5 · Who and what money

Authors and funding

16 authors.

Pallavi ThakerDepartment of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India.
Nikhil ShindeDepartment of Clinical Sciences, ICMR-Centre for Research, Management and Control of Hemoglobinopathies, Chandrapur, Maharashtra, India.
Suchitra SurveDepartment of Child and Health Research, ICMR-National Institute for Research in Reproductive and Child Health-Model Rural Health Research Unit, Palghar, Maharashtra, India.
Kalpita GawitDepartment of Clinical Sciences, ICMR-Centre for Research, Management and Control of Hemoglobinopathies, Chandrapur, Maharashtra, India.
Priya HariharanDepartment of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India.
Rajasubramanium ShanmugamDepartment of Genetics, ICMR-National Institute of Research in Tribal Health, Jabalpur, Madhya Pradesh, India.
Anna Salomi KerkettaDepartment of Clinical Sciences, ICMR-Regional Medical Research Center, Bhubaneswar, Odisha, India.
Manoranjan RanjitDepartment of Clinical Sciences, ICMR-Regional Medical Research Center, Bhubaneswar, Odisha, India.
Kapilkumar DaveSociety for Education, Welfare, and Action (SEWA)-Rural, Jhagadia, Gujarat, India.
Mahendra ThakorDepartment of Virology, ICMR-National Institute for Implementation Research on Non-Communicable Diseases, Jodhpur, Rajasthan, India.
Suman Sundar MohantyDepartment of Virology, ICMR-National Institute for Implementation Research on Non-Communicable Diseases, Jodhpur, Rajasthan, India.
Ragini KulkarniDepartment of Operational and Implementation Research, ICMR-National Institute for Research in Reproductive and Child Health-Model Rural Health Research Unit, Palghar, Maharashtra, India.
Harpreet KaurDivision of Communicable Diseases, Indian Council of Medical Research, New Delhi, India.
Apoorva PandeyDepartment of Virology, ICMR-National Institute for Implementation Research on Non-Communicable Diseases, Jodhpur, Rajasthan, India.
Manisha MadkaikarDepartment of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India.
Anita NadkarniDepartment of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background & objectives Sickle cell disease (SCD) is a common, life-limiting genetic disorder in India. It is best managed when diagnosed early through newborn screening, which requires a reliable, rapid and an affordable point-of-care test for diagnosis. The study aimed to evaluate the diagnostic accuracy of HemoTypeSC as point-of care for detecting SCD in newborn screening. Additionally, the study assessed the feasibility of implementing HemoTypeSC in poor resource settings. Methods We conducted a prospective multicentre diagnostic accuracy study using an investigational assay HemoTypeSC, and compared it with the reference ('Gold-standard') High performance liquid chromatography (HPLC) during the year 2019-20. Six different study centers were selected to evaluate the performance of the test across different climatic and geographical locations. Results A total of 1725 newborn babies were screened from six participating centers. The samples were analyzed by both HemoTypeSC and HPLC. HemoTypeSC correctly identified the 14/15 SCD cases [sensitivity 93.3% (95% confidence interval (CI): 68-99.8%) and specificity 100% (95% CI: 99.7-100%)] and 192/200 sickle cell trait cases [sensitivity 96% (92.2-98.2%, CI 95%) and specificity 99.8% (95% CI: 99.5-99.9%)]. The accuracy of HemoTypeSC to detect SCD and sickle cell trait was found to be 99.9 per cent (95% CI: 99.6-100%) and 99.5 per cent (95% CI: 99-99.7%), respectively. Interpretation & conclusions HemoTypeSC can be a viable alternative to HPLC in resource-limited regions with a high prevalence of SCD to provide timely diagnosis and support newborn screening programmes.

Indexed as

Anemia, Sickle CellNeonatal ScreeningChromatography, High Pressure LiquidFemaleHumansIndiaInfant, NewbornMalePoint-of-Care TestingHemoTypeSCIndianewbornpoint of care (POC)sickle cell disease

Identifiers

PMID41296576
PMCPMC12744556

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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.