TY - JOUR T1 - Compatibility of a novel filter paper-based bio-safe sputum transport kit with Line Probe Assay for diagnosing drug-resistant tuberculosis: a single-site evaluation study JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00137-2021 SP - 00137-2021 AU - Divya Anthwal AU - Rakesh Kumar Gupta AU - Ritu Singhal AU - Manpreet Bhalla AU - Ajoy Kumar Verma AU - Khalid Umar Khayyam AU - Vithal Prasad Myneedu AU - Rohit Sarin AU - Ashawant Gupta AU - Nalini Kant Gupta AU - Manjula Singh AU - Jaya Sivaswami Tyagi AU - Sagarika Haldar Y1 - 2021/01/01 UR - http://openres.ersjournals.com/content/early/2021/04/15/23120541.00137-2021.abstract N2 - Background Near-patient access to appropriate tests is a major obstacle for the efficient diagnosis of Tuberculosis (TB) and associated drug resistance.Methods We recently developed the “TB Concentration & Transport” kit for bio-safe, ambient-temperature transportation of dried sputum on Trans-Filter, and the “TB DNA Extraction” kit for DNA extraction from Trans-Filter for determining drug resistance by DNA sequencing. In the present study, we evaluated the compatibility of Kit-extracted DNA with Hain's Line Probe Assays (LPAs), which are endorsed by National TB programmes for the detection of drug resistance in sputum collected from presumptive Multi-drug resistant TB patients (n=207).Results Trans-Filter-extracted DNA was seamlessly integrated with the LPA protocol (Kit-LPA). The sensitivity of Kit-LPA for determining drug resistance was 83.3% for rifampicin (95% Confidence Interval [CI]: 52, 98%), 77.7% for isoniazid (95% CI: 52, 94%), 85.7% for fluoroquinolones (95% CI: 42, 100%) and 66.6% for aminoglycosides (95% CI: 9, 99%), with a specificity range of 93.7% (95% CI: 87, 97) to 99.1% (95% CI: 95, 100) using phenotypic drug susceptibility testing (DST) as a reference standard. A high degree of concordance was noted between results obtained from Kit-LPA and LPA [99% to 100% (κ value: 0.83–1.0)].Conclusions This study demonstrates successful integration of our developed kits with LPA. The adoption of these kits across Designated Microscopy Centres in India can potentially overcome the existing challenge of transporting infectious sputum at controlled temperature to centralised testing laboratories and can provide rapid near-patient cost-effective “Universal DST” services to TB subjects residing in remote areas.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Ms. Anthwal reports personal fees from ICMR (Fellowship support), during the conduct of the study; In addition, Ms. Anthwal has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending.Conflict of interest: Mr. Gupta has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending and Mr Gupta manufactured and provided the ‘TB Concentration & Transport’ and ‘TB DNA Extraction’ kits and participated in training of the laboratory staff who used the kit.Conflict of interest: Dr. Singhal reports grants from ICMR, during the conduct of the study.Conflict of interest: Dr. Bhalla reports grants from ICMR, during the conduct of the study.Conflict of interest: Dr. Verma reports grants from ICMR, during the conduct of the study; In addition, Dr. Verma has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending.Conflict of interest: Dr. Khayyam reports grants from ICMR, during the conduct of the study.Conflict of interest: Dr. Myneedu reports grants from ICMR, during the conduct of the study; In addition, Dr. Myneedu has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending.Conflict of interest: Dr. Sarin reports grants from ICMR, during the conduct of the study; In addition, Dr. Sarin has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending.Conflict of interest: Dr. Gupta has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending and Dr. Gupta manufactured and provided the ‘TB Concentration & Transport’ and ‘TB DNA Extraction’ kits and participated in training of the laboratory staff who used the kit. .Conflict of interest: Mr. Gupta has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending and Mr Gupta manufactured and provided the ‘TB Concentration & Transport’ and ‘TB DNA Extraction’ kits and participated in training of the laboratory staff who used the kit.Conflict of interest: Dr. Singh has nothing to disclose.Conflict of interest: Dr. Sivaswami Tyagi reports grants from ICMR , during the conduct of the study; In addition, Dr. Sivaswami Tyagi has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending.Conflict of interest: Dr. Haldar reports grants from ICMR, during the conduct of the study; In addition, Dr. Haldar has a patent “Apparatus and method for processing a sample for rapid diagnosis of tuberculosis and safe transport of bacteria” Patent application number- 201811042155 pending. 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