{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T17:07:35Z","timestamp":1780592855099,"version":"3.54.1"},"reference-count":7,"publisher":"Scientific Scholar","content-domain":{"domain":["ijmr.org.in"],"crossmark-restriction":true},"short-container-title":["Indian J Med Res"],"abstract":"<jats:sec>\n<jats:title>Background &amp; objectives<\/jats:title>\n<jats:p>The global target set by the United Nations (UN) high-level meeting on Tuberculosis (TB) for coverage of rapid molecular tests is 100 per cent by 2027. Rapid, affordable molecular tests for early detection of TB are the need of the hour. This study aimed to evaluate the diagnostic accuracy of an open real-time PCR (RT-PCR) assay, Quantiplus\u00ae, with reference to Mycobacteria Growth Indicator Tube (MGIT) liquid culture.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>We conducted a prospective multi-centric diagnostic accuracy study of Quantiplus\u00ae assay (version 2.0) at three sites in India for the detection of pulmonary TB in sputum with culture as the reference standard, compared with Xpert\u00ae MTB\/RIF. A total of 657 adults (&gt;18 yr) with presumptive TB were enrolled consecutively. The Quantiplus\u00ae assay uses an extraction-free, quick-lysis protocol and three gene targets for RT-PCR.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Of the 644 samples analysed, 37 per cent were culture-positive and 32 per cent were smear-positive. The sensitivity and specificity of Quantiplus\u00ae assay with reference to MGIT culture were 86 per cent [95% confidence interval (CI): 81-90] and 96 per cent (95% CI: 94-98), respectively, at Ct \u2264 38. The positive and negative predictive values (PPV\/NPV) were 93 per cent (95% CI: 89-96%) and 92 per cent (95% CI: 89-94%), respectively. Among the 73 smear-negative culture-positive specimens, the sensitivity and specificity were 61.6 per cent (95% CI: 50-73) and 97 per cent (95% CI: 92-98.6), respectively. The performance of Quantiplus\u00ae assay(v2.0) was comparable to Xpert MTB\/RIF<jats:sup>\u00ae<\/jats:sup> (\u03ba=0.83, SE=0.02) at Ct \u226438.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Interpretation &amp; conclusions<\/jats:title>\n<jats:p>The flexibility of the open RT-PCR assay to be used in any RT-PCR machine makes it a very low-cost (&lt;2 US$) alternative to the expensive cartridge-based tests. This is the first report of validation of an open system RT-PCR assay for the detection of pulmonary TB.<\/jats:p>\n<\/jats:sec>","DOI":"10.25259\/ijmr_767_2025","type":"journal-article","created":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T05:48:12Z","timestamp":1747288092000},"page":"346-353","update-policy":"https:\/\/doi.org\/10.25259\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic accuracy of real-time PCR assay \u2018Quantiplus\u00ae MTB FAST\u2019 for detection of adult pulmonary tuberculosis (PTB): A multi-centric study"],"prefix":"10.25259","volume":"161","author":[{"given":"Madhumathi","family":"Jayaprakasam","sequence":"first","affiliation":[{"name":"Division of Communicable Diseases, #Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy Sarojini","family":"Michael","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology, Christian Medical College, Vellore, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parul","family":"Jain","sequence":"additional","affiliation":[{"name":"Department of Microbiology, King George\u2019s Medical University, Lucknow, Uttar Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaoli","family":"Basu","sequence":"additional","affiliation":[{"name":"Department of Microbiology, PD Hinduja Hospital and MRC, Mumbai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanchan","family":"Ajbani","sequence":"additional","affiliation":[{"name":"Department of Microbiology, PD Hinduja Hospital and MRC, Mumbai, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siva Kumar","family":"Shanmugam","sequence":"additional","affiliation":[{"name":"Department of Bacteriology, ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marilyn Mary","family":"Ninan","sequence":"additional","affiliation":[{"name":"Department of Clinical Microbiology, Christian Medical College, Vellore, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hansraj","family":"Choudhary","sequence":"additional","affiliation":[{"name":"Division of Communicable Diseases, #Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amita","family":"Jain","sequence":"additional","affiliation":[{"name":"Department of Microbiology, King George\u2019s Medical University, Lucknow, Uttar Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravindra Mohan","family":"Pandey","sequence":"additional","affiliation":[{"name":"Division of Communicable Diseases, #Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Research Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nivedita","family":"Gupta","sequence":"additional","affiliation":[{"name":"Division of Communicable Diseases, #Indian Council of Medical Research, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10894","published-online":{"date-parts":[[2025,5,16]]},"reference":[{"key":"10.25259\/IJMR_767_2025\/ref-5","doi-asserted-by":"publisher","first-page":"246","DOI":"10.4103\/ijmr.ijmr_2316_23","article-title":"Evaluation of molecular diagnostic test for detection of adult pulmonary tuberculosis: A generic protocol","volume":"159","author":"Jayaprakasam","year":"2024","journal-title":"Indian J Med Res"},{"key":"10.25259\/IJMR_767_2025\/ref-6","doi-asserted-by":"publisher","first-page":"2100526","DOI":"10.1183\/13993003.00526-2021","article-title":"A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays","volume":"58","author":"Penn-Nicholson","year":"2021","journal-title":"Eur Respir J"},{"key":"10.25259\/IJMR_767_2025\/ref-9","volume-title":"Practical manual on tuberculosis laboratory strengthening, 2022 update","author":"World Health Organization","year":"2022"},{"key":"10.25259\/IJMR_767_2025\/ref-10","doi-asserted-by":"publisher","first-page":"CD015543","DOI":"10.1002\/14651858.CD015543.pub2","article-title":"Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents","volume":"3","author":"Inbaraj","year":"2025","journal-title":"Cochrane Database Syst Rev"},{"key":"10.25259\/IJMR_767_2025\/ref-11","doi-asserted-by":"publisher","first-page":"1149741","DOI":"10.3389\/fcimb.2023.1149741","article-title":"Efficacy of Xpert in tuberculosis diagnosis based on various specimens: A systematic review and meta-analysis","volume":"13","author":"Gong","year":"2023","journal-title":"Front Cell Infect Microbiol"},{"key":"10.25259\/IJMR_767_2025\/ref-12","doi-asserted-by":"publisher","first-page":"e0180725","DOI":"10.1371\/journal.pone.0180725","article-title":"Diagnostic accuracy of Xpert MTB\/RIF for tuberculosis detection in different regions with different endemic burden: A systematic review and meta-analysis","volume":"12","author":"Li","year":"2017","journal-title":"PLoS One"},{"key":"10.25259\/IJMR_767_2025\/ref-13","doi-asserted-by":"crossref","DOI":"10.2471\/B09111","volume-title":"Target product profiles for tuberculosis diagnosis and detection of drug resistance","author":"World Health Organization","year":"2024"}],"container-title":["The Indian Journal of Medical Research"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/ijmr.org.in\/diagnostic-accuracy-of-real-time-pcr-assay-quantiplus-mtb-fast-for-detection-of-adult-pulmonary-tuberculosis-ptb-a-multi-centric-study\/","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/ijmr.org.in\/diagnostic-accuracy-of-real-time-pcr-assay-quantiplus-mtb-fast-for-detection-of-adult-pulmonary-tuberculosis-ptb-a-multi-centric-study\/","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,1]],"date-time":"2025-06-01T06:19:12Z","timestamp":1748758752000},"score":1,"resource":{"primary":{"URL":"http:\/\/ijmr.org.in\/diagnostic-accuracy-of-real-time-pcr-assay-quantiplus-mtb-fast-for-detection-of-adult-pulmonary-tuberculosis-ptb-a-multi-centric-study\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,16]]},"references-count":7,"alternative-id":["10.25259\/IJMR_767_2025"],"URL":"https:\/\/doi.org\/10.25259\/ijmr_767_2025","relation":{},"ISSN":["0971-5916"],"issn-type":[{"value":"0971-5916","type":"print"}],"subject":[],"published":{"date-parts":[[2025,5,16]]},"article-number":"346"}}