Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India

• DOI: 10.3389/fpubh.2023.1255756
• Publication Date: 2023-10-11T00:37:11Z
• Authors: Radha Gopalaswamy; Nishant Kumar; Himanshu Vashistha; Priya Rajendran; Jyoti Kayesth; Carel Joseph Pera...; Satabdi Kashyap; Shreeparna Ghosh; Habakkuk Yumo; Moe Moore; Sridhar Anand; Ranjani Ramachandran; Umesh Alavadi; Sanjeev Saini; Sivakumar Shanmugam
• Keywords: Indeterminate

Introduction Truenat MTB-RIF assay (Truenat), a nucleic acid amplification test (NAAT), is real-time polymerase chain reaction (RT-PCR) chip-based that can detect Mycobacterium tuberculosis ( Mtb ) and rifampicin (RIF) drug resistance using portable, battery-operated devices. The National TB Elimination Program (NTEP) in India introduced this novel tool at the district subdistrict level 2020. This study aimed to assess causes of inconclusive results (invalid results, errors, indeterminate results) MTB RIF testing NTEP sites root these programmatic setting. Methods data from 1,690 functional under April June 2021 were analyzed rates invalid results. Following analysis, 12 selected based on site performance testing, diversity climatic conditions, geographical terrain. These visited their high low structured checklist. Results A total 327,649 tests performed for analyzed. rate was 5.2% [95% confidence interval (CI): 5.11–5.26; n = 16,998] errors 2.5% (95% CI: 2.46–2.57; 8,240) chip testing. For Mtb-positive samples tested detection 40,926), 15.3% 14.97–15.67; 6,267) 1.6% 1.53–1.78; 675). There 40.1% retesting gap 78.2% RR Among retested, 27.9% 27.23–28.66; 4,222) Mtb-positive, 9.2% 7.84–10.76; 139) detected as RR. Conclusion main affecting include suboptimal adherence standard operating procedures (SOPs), inadequate training, improper storage kits, sputum quality, lack quality control, delays rectification machine issues. Root cause analysis identified strengthening external supervision could improve Ensuring hands-on training technicians with are major recommendations while planning scale-up. consolidated into technical guidance documents videos disseminated laboratory staff working tiered network laboratories order performance.