Pilot implementation result of frequency, distribution, and factors associated with unsuccessful tests and error rates at Truenat sites in Nigeria.

Study was designed to determine frequency and distribution of unsuccessful test results and factors associated with high Error rates (ER) in Truenat sites in Nigeria. A retrospective cross-sectional study was done involving secondary data analysis of 38 Truenat facilities between January and December 2022. Socio-demographic information of key Truenat lab staff were collected. High ER was determined by proportion of health facilities with > 3% unsuccessful tests. A total of 56,799 Trueprep DNA extractions were conducted, unsuccessful tests were 1043. (ER = 1.8%). For Truenat MTB, 56,749 tests were conducted and 1350 were unsuccessful. (ER = 2.4%). High Trueprep DNA extraction test errors was recorded in 23.7% of facilities and 31.6% for Truenat MTB tests. No factor significantly influenced any of the test errors. Unsuccessful Trueprep test error codes were 1021 while unsuccessful Truelab test error codes were 1198. Highest Trueprep error recorded was cartridge error (44.1%), while highest Truelab error was internal control not amplifying in PCR (78%). Implementation of Truenat as a new tool for TB diagnosis in Nigeria is associated with low ERs. It is recommended that Truenat training curriculum in-country be updated to focus on and address the possible underlying causes of these errors as the country plans for scale up.