Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India
IntroductionTruenat 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 El...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-10-01
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| Series: | Frontiers in Public Health |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2023.1255756/full |
| _version_ | 1827795785468608512 |
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| author | Radha Gopalaswamy Nishant Kumar Himanshu Vashistha Priya Rajendran Jyoti Kayesth Carel Joseph Peravali Satabdi Kashyap Shreeparna Ghosh Habakkuk Yumo Moe Moore Sridhar Anand Ranjani Ramachandran Umesh Alavadi Sanjeev Saini Sivakumar Shanmugam |
| author_facet | Radha Gopalaswamy Nishant Kumar Himanshu Vashistha Priya Rajendran Jyoti Kayesth Carel Joseph Peravali Satabdi Kashyap Shreeparna Ghosh Habakkuk Yumo Moe Moore Sridhar Anand Ranjani Ramachandran Umesh Alavadi Sanjeev Saini Sivakumar Shanmugam |
| author_sort | Radha Gopalaswamy |
| collection | DOAJ |
| description | IntroductionTruenat 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.MethodsTruenat 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.ResultsA 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.ConclusionThe 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. |
| first_indexed | 2024-03-11T18:56:16Z |
| format | Article |
| id | doaj.art-35d56f60092b4ac2ac185fef14435d43 |
| institution | Directory Open Access Journal |
| issn | 2296-2565 |
| language | English |
| last_indexed | 2024-03-11T18:56:16Z |
| publishDate | 2023-10-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Public Health |
| spelling | doaj.art-35d56f60092b4ac2ac185fef14435d432023-10-11T00:36:58ZengFrontiers Media S.A.Frontiers in Public Health2296-25652023-10-011110.3389/fpubh.2023.12557561255756Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of IndiaRadha Gopalaswamy0Nishant Kumar1Himanshu Vashistha2Priya Rajendran3Jyoti Kayesth4Carel Joseph Peravali5Satabdi Kashyap6Shreeparna Ghosh7Habakkuk Yumo8Moe Moore9Sridhar Anand10Ranjani Ramachandran11Umesh Alavadi12Sanjeev Saini13Sivakumar Shanmugam14ICMR-National Institute for Research in Tuberculosis, Chennai, IndiaCentral Tuberculosis Division, Ministry of Health and Family Welfare, New Delhi, IndiaUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesICMR-National Institute for Research in Tuberculosis, Chennai, IndiaUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesWorld Health Organization, New Delhi, IndiaWorld Health Organization, New Delhi, IndiaUnited States Agency for International Development, New Delhi, IndiaUSAID’s Infectious Diseases Detection and Surveillance (IDDS) Project Awarded to Inner City Fund (ICF), Virginia, VA, United StatesICMR-National Institute for Research in Tuberculosis, Chennai, IndiaIntroductionTruenat 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.MethodsTruenat 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.ResultsA 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.ConclusionThe 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.https://www.frontiersin.org/articles/10.3389/fpubh.2023.1255756/fullTruenat MTB-RIF testingMTB invalid/errorsRIF indeterminate/errorsTruenat inconclusive resultsRIF indeterminateerrors in Truenat testing |
| spellingShingle | Radha Gopalaswamy Nishant Kumar Himanshu Vashistha Priya Rajendran Jyoti Kayesth Carel Joseph Peravali Satabdi Kashyap Shreeparna Ghosh Habakkuk Yumo Moe Moore Sridhar Anand Ranjani Ramachandran Umesh Alavadi Sanjeev Saini Sivakumar Shanmugam Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India Frontiers in Public Health Truenat MTB-RIF testing MTB invalid/errors RIF indeterminate/errors Truenat inconclusive results RIF indeterminate errors in Truenat testing |
| title | Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India |
| title_full | Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India |
| title_fullStr | Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India |
| title_full_unstemmed | Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India |
| title_short | Comprehensive assessment of invalid and indeterminate results in Truenat MTB-RIF testing across sites under the national TB elimination program of India |
| title_sort | comprehensive assessment of invalid and indeterminate results in truenat mtb rif testing across sites under the national tb elimination program of india |
| topic | Truenat MTB-RIF testing MTB invalid/errors RIF indeterminate/errors Truenat inconclusive results RIF indeterminate errors in Truenat testing |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2023.1255756/full |
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