{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:55:02Z","timestamp":1787025302073,"version":"build-2736575974"},"reference-count":28,"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 Timely detection of population with \u03b2-thalassemia trait (BTT) followed by genetic counselling is an advocated method of preventing the birth of a child with \u03b2-thalassemia major. In this study we aim to assess the diagnostic accuracy of Gazelle, a point-of-care (POC) testing device, in screening for BTT in hospital laboratory setting.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Standards for Reporting Diagnostic Accuracy (STARD) guidelines were followed in developing study design, recruiting study participants and sample size calculation for the current research. A consecutive sample of 446 participants was recruited for this study and was tested for the reference test Gazelle as well as the gold standard cation exchange high performance liquid chromatography (CE-HPLC). Low serum ferritin levels are known to interfere with the production of HbA2 and in turn lead to false negative results. Hence, the study population was divided into two categories with respect to a cut off value of 15ng\/dl of serum ferritin and the results were analyzed.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Overall diagnostic accuracy of Gazelle for detecting BTT was found to be 95.3 per cent with a confidence interval (CI) of (92.9 - 97.1) and the sensitivity was 94.5 per cent with a 95% CI of (84.8 - 98.8). When analyzed by the serum ferritin level the diagnostic accuracy was found to be 94.7 per cent (91.1% - 97.1%) and 95.7 per cent (91.8% - 98.1%) for participants with serum ferritin level as > 15 ng\/ml and < 15 ng\/ml, respectively.<\/jats:p>\n <\/jats:sec>\n \n Interpretation & conclusions<\/jats:title>\n This study found Gazelle to be a good screening tool for \u03b2-thalassemia trait with high sensitivity, specificity and accuracy. However, it is recommended that the final confirmation of the diagnosis done by a diagnostic test like HPLC or Capillary Zone Electrophoresis (CZE).<\/jats:p>\n <\/jats:sec>","DOI":"10.25259\/ijmr_1986_23","type":"journal-article","created":{"date-parts":[[2024,10,23]],"date-time":"2024-10-23T12:47:55Z","timestamp":1729687675000},"page":"194-200","update-policy":"https:\/\/doi.org\/10.25259\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Assessment of diagnostic accuracy of Gazelle: A point-of-care testing device for screening \u03b2-thalassemia trait"],"prefix":"10.25259","volume":"160","author":[{"given":"Neha","family":"Singh","sequence":"first","affiliation":[{"name":"Centre for Community Medicine, All India Institute of Medical Science, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tulika","family":"Seth","sequence":"additional","affiliation":[{"name":"Department of Haematology, All India Institute of Medical Science, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmita","family":"Dass","sequence":"additional","affiliation":[{"name":"Department of Haematology, All India Institute of Medical Science, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10894","published-online":{"date-parts":[[2024,10,22]]},"reference":[{"key":"10.25259\/ijmr_1986_23\/ref-1","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/S0140-6736(17)31822-6","article-title":"Thalassaemia","volume":"391","author":"Taher","year":"2018","journal-title":"Lancet"},{"key":"10.25259\/ijmr_1986_23\/ref-2","doi-asserted-by":"crossref","first-page":"1135","DOI":"10.1056\/NEJMra050436","article-title":"\u03b2-thalassemia","volume":"353","author":"Rund","year":"2005","journal-title":"N Engl J Med"},{"key":"10.25259\/ijmr_1986_23\/ref-3","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1056\/NEJMra2021838","article-title":"\u03b2-thalassemia","volume":"384","author":"Taher","year":"2021","journal-title":"N Engl J Med"},{"key":"10.25259\/ijmr_1986_23\/ref-4","doi-asserted-by":"crossref","first-page":"480","DOI":"10.2471\/BLT.06.036673","article-title":"Global epidemiology of haemoglobin disorders and derived service indicators","volume":"86","author":"Modell","year":"2008","journal-title":"Bull World Health Organ"},{"key":"10.25259\/ijmr_1986_23\/ref-5","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1177\/014107680109401119","article-title":"Disorders of haemoglobin: Genetics, pathophysiology and clinical management","volume":"94","author":"Somervaille","year":"2001","journal-title":"J R Soc Med"},{"key":"10.25259\/ijmr_1986_23\/ref-6","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/ejh.13512","article-title":"Changing patterns in the epidemiology of \u03b2\u2010thalassemia","volume":"105","author":"Kattamis","year":"2020","journal-title":"Eur J Haematol"},{"key":"10.25259\/ijmr_1986_23\/ref-7","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1136\/jmg.18.4.266","article-title":"Effectiveness of one tube osmotic fragility screening in detecting beta-thalassaemia trait","volume":"18","author":"Kattamis","year":"1981","journal-title":"J Med Genet"},{"key":"10.25259\/ijmr_1986_23\/ref-8","first-page":"3519","article-title":"Hemechip: An automated portable microchip electrophoresis platform for point-of-care sickle cell disease screening","volume":"130","author":"Hasan","year":"2017","journal-title":"Blood"},{"key":"10.25259\/ijmr_1986_23\/ref-9","doi-asserted-by":"crossref","first-page":"2525","DOI":"10.1039\/C9AN02250C","article-title":"Paper based microchip electrophoresis for point-of-care haemoglobin testing","volume":"145","author":"Hasan","year":"2020","journal-title":"Analyst"},{"key":"10.25259\/ijmr_1986_23\/ref-10","first-page":"37","article-title":"Integrated point-of-care device for anaemia detection and haemoglobin variant identification","author":"An","year":"2019","journal-title":"IEEE Trans Biomed Eng"},{"key":"10.25259\/ijmr_1986_23\/ref-11","first-page":"826","article-title":"STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies","volume":"277","author":"Bossuyt","year":"2015","journal-title":"Br Med J"},{"key":"10.25259\/ijmr_1986_23\/ref-12","doi-asserted-by":"crossref","first-page":"895","DOI":"10.1111\/j.1553-2712.1996.tb03538.x","article-title":"Statistical methodology: I. 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