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TB diagnosis has been simplified in India following advances in available diagnostic tools. This facilitates private doctors' "patient first" approach toward early diagnosis; however, costs remain high. India's NTEP established a TB diagnostic network, which is free for patients and incentivizes private doctors to participate. Drawing from this context led to the design and implementation of the One-Stop TB Diagnostic Solution model, which was conducted in the Hisar district, Haryana, allowing specimens from presumptive TB patients from private doctors to be collected and tested as per NTEPs diagnostic algorithm. A subset of data pertaining to private doctors was analyzed for the project period. Qualitative data were also collected by interviewing doctors using a snowball method to capture doctors' perception about the model. Out of 1159 specimens collected from 60 facilities, MTB was detected in 32% and rifampicin resistance was detected in 7% specimens. All specimens went through the diagnostic algorithm. Thirty doctors interviewed were satisfied with the services offered and were appreciative of the program that implements this "patient centric" model. Results from implementation indicate the need to strengthen private diagnostics through a certification process to ensure provision of quality TB diagnostic services.

Introduction: Truenat MTB-RIF assay (Truenat), a nucleic acid amplification test (NAAT), is a real-time polymerase chain reaction (RT-PCR) chip-based assay 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 and subdistrict level in 2020. This study aimed to assess the level and causes of inconclusive results (invalid results, errors, and indeterminate results) in MTB and RIF testing at NTEP sites and the root causes of these in the programmatic setting., Methods: Truenat testing data from 1,690 functional Truenat sites under the NTEP from April to June 2021 were analyzed to assess the rates of errors, invalid MTB results, and indeterminate RIF results. Following this analysis, 12 Truenat sites were selected based on site performance in Truenat testing, diversity of climatic conditions, and geographical terrain. These sites were visited to assess the root causes of their high and low rates of inconclusive results using a structured checklist., Results: A total of 327,649 Truenat tests performed for MTB and RIF testing were analyzed. The rate of invalid MTB results was 5.2% [95% confidence interval (CI): 5.11-5.26; n = 16,998] and the rate of errors was 2.5% (95% CI: 2.46-2.57; n = 8,240) in Truenat MTB chip testing. For Mtb-positive samples tested using the Truenat RIF chip for detection of RIF resistance ( n = 40,926), the rate of indeterminate results was 15.3% (95% CI: 14.97-15.67; n = 6,267) and the rate of errors was 1.6% (95% CI: 1.53-1.78; n = 675). There was a 40.1% retesting gap for Mtb testing and a 78.2% gap for inconclusive RR results. Among the inconclusive results retested, 27.9% (95% CI: 27.23-28.66; n = 4,222) were Mtb-positive, and 9.2% (95% CI: 7.84-10.76; n = 139) were detected as RR., Conclusion: The main causes affecting Truenat testing performance include suboptimal adherence to standard operating procedures (SOPs), inadequate training, improper storage of testing kits, inadequate sputum quality, lack of quality control, and delays in the rectification of machine issues. Root cause analysis identified that strengthening of training, external quality control, and supervision could improve the rate of inconclusive results. Ensuring hands-on training of technicians for Truenat testing and retesting of samples with inconclusive results are major recommendations while planning for Truenat scale-up. The recommendations from the study were consolidated into technical guidance documents and videos and disseminated to laboratory staff working at the tiered network of TB laboratories under the NTEP in order to improve Truenat MTB-RIF testing performance., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Gopalaswamy, Kumar, Vashistha, Rajendran, Kayesth, Peravali, Kashyap, Ghosh, Yumo, Moore, Anand, Ramachandran, Alavadi, Saini and Shanmugam.)