Discordance of the Repeat GeneXpert MTB/RIF test for Rifampicin resistance detection among patients Initiating MDR-TB treatment in Uganda
Abstract Background The Global Laboratory Initiative (GLI) guidelines recommend to repeat GeneXpertMTB/RIF (XpertMTB/RIF) in patients with a low-pretest probability of rifampicin-resistance (RR). Design/Methods In a cross-sectional study using results of sputum specimens collected from participants screened for the STREAM 2 trial. We recruited all patients with XpertMTB/RIF RR-TB detected who were referred for RR/MDR-TB treatment initiation at Mulago National Referral Hospital, Kampala, between September 2017 and October 2019. At baseline, smear microscopy, repeat XpertMTB/RIF, Xpert Ultra and MTBDRplus assays were done on sputum specimens. Culture-based drug-susceptibility testing (DST) were done on discordant specimens. We analysed the prevalence and factors associated with discordance between initial and repeat XpertMTB/RIF RR and false XpertMTB/RIF RR. False XpertMTB/RIF RR was defined as no RR detected by any of Xpert Ultra, LPA or culture DST (reference comparator). Results A total of 126/130 patients had repeat XpertMTB/RIF results of which, 97 (77.0%) had M. tuberculosis detected of whom, 81 (83.5%) had RR detected, and 1 (1.0%) had RR indeterminate. The prevalence of discordant XpertMTB/RIF RR was 15/96 (15.6%) whereas false XpertMTB/RIF RR prevalence was 10/96 (10.4%). Low bacillary load sputum specimens were more likely to have discordant XpertMTB/RIF RR and false XpertMTB/RIF RR results, aOR (p-value: 95%CI), 0.04 (0.01; 0.00-0.37) and 0.02 (0.01; 0.01-0.35) respectively. Conclusion Our findings show a high false-positive rifampicin resistance rate in low TB burden patients, which calls for repeat testing in order to prevent unnecessary prescription of anti MDR-TB therapy.