{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T03:05:19Z","timestamp":1771470319282,"version":"3.50.1"},"reference-count":21,"publisher":"Scientific Scholar","content-domain":{"domain":["ijmr.org.in"],"crossmark-restriction":true},"short-container-title":["Indian J Med Res"],"abstract":"\n Background & objectives<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We conducted a prospective multicentre diagnostic accuracy study using an investigational assay HemoTypeSC, and compared it with the reference (\u2018Gold-standard\u2019) 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Interpretation & conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.25259\/ijmr_193_2025","type":"journal-article","created":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T11:18:16Z","timestamp":1762946296000},"page":"399-403","update-policy":"https:\/\/doi.org\/10.25259\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic accuracy of HemoTypeSC for detecting sickle cell disease in newborns: A multicentric study"],"prefix":"10.25259","volume":"162","author":[{"given":"Pallavi","family":"Thaker","sequence":"first","affiliation":[{"name":"Department of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikhil","family":"Shinde","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, ICMR-Centre for Research, Management and Control of Hemoglobinopathies, Chandrapur, Maharashtra, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suchitra","family":"Surve","sequence":"additional","affiliation":[{"name":"Department of Child and Health Research, ICMR-National Institute for Research in Reproductive and Child Health-Model Rural Health Research Unit, Palghar, Maharashtra, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kalpita","family":"Gawit","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, ICMR-Centre for Research, Management and Control of Hemoglobinopathies, Chandrapur, Maharashtra, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priya","family":"Hariharan","sequence":"additional","affiliation":[{"name":"Department of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajasubramanium","family":"Shanmugam","sequence":"additional","affiliation":[{"name":"Department of Genetics, ICMR-National Institute of Research in Tribal Health, Jabalpur, Madhya Pradesh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna Salomi","family":"Kerketta","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, ICMR-Regional Medical Research Center, Bhubaneswar, Odisha, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manoranjan","family":"Ranjit","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, ICMR-Regional Medical Research Center, Bhubaneswar, Odisha, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kapilkumar","family":"Dave","sequence":"additional","affiliation":[{"name":"Society for Education, Welfare, and Action (SEWA)-Rural, Jhagadia, Gujarat, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mahendra","family":"Thakor","sequence":"additional","affiliation":[{"name":"Department of Virology, ICMR-National Institute for Implementation Research on Non-Communicable Diseases, Jodhpur, Rajasthan, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suman Sundar","family":"Mohanty","sequence":"additional","affiliation":[{"name":"Department of Virology, ICMR-National Institute for Implementation Research on Non-Communicable Diseases, Jodhpur, Rajasthan, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ragini","family":"Kulkarni","sequence":"additional","affiliation":[{"name":"Department of Operational and Implementation Research, ICMR-National Institute for Research in Reproductive and Child Health-Model Rural Health Research Unit, Palghar, Maharashtra, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harpreet","family":"Kaur","sequence":"additional","affiliation":[{"name":"Division of Communicable Diseases, Indian Council of Medical Research, New Delhi, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Apoorva","family":"Pandey","sequence":"additional","affiliation":[{"name":"Department of Virology, ICMR-National Institute for Implementation Research on Non-Communicable Diseases, Jodhpur, Rajasthan, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manisha","family":"Madkaikar","sequence":"additional","affiliation":[{"name":"Department of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anita","family":"Nadkarni","sequence":"additional","affiliation":[{"name":"Department of Haematogenetics, ICMR-National Institute of Immunohaematology, Mumbai, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"10894","published-online":{"date-parts":[[2025,11,12]]},"reference":[{"key":"10.25259\/IJMR_193_2025\/ref-1","doi-asserted-by":"publisher","first-page":"725","DOI":"10.1016\/S0140-6736(97)07330-3","article-title":"Sickle-cell disease","volume":"350","author":"Serjeant","year":"1997","journal-title":"Lancet"},{"key":"10.25259\/IJMR_193_2025\/ref-2","doi-asserted-by":"publisher","first-page":"101678","DOI":"10.1016\/j.cegh.2024.101678","article-title":"Prevalence of sickle cell disease, sickle cell trait and HBS-beta-thalassemia in India: A systematic review and meta-analysis","volume":"28","author":"Rao","year":"2024","journal-title":"Clin Epidemiol Global Health"},{"key":"10.25259\/IJMR_193_2025\/ref-3","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1097\/MOH.0000000000000029","article-title":"Sickle cell disease in 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