Diagnostic Evaluation of Non-Interpretable Results Associated with rpoB Gene in Genotype MTBDRplus Ver 2.0

Singh, Binit Kumar; Sharma, Reetika; Kodan, Parul; Soneja, Manish; Jorwal, Pankaj; Nischal, Neeraj; Biswas, Ashutosh; Sarin, Sanjay; Ramachandran, Ranjani; Wig, Naveet

doi:10.4046/trd.2020.0039

Cited by 3 publications

(1 citation statement)

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“…One patient with negative BD MAX and positive phenotypic DST results for RIF resistance also showed negative LPA results for RIF resistance. The causes of false-negative results of molecular methods for RIF resistance have rarely been studied, but previous studies have suggested that some strains with S531W and S531F mutations within the rpoB gene are non-interpretable via LPA [ 27 ], and some strains with L533P mutation susceptible via Xpert [ 28 ]. Additionally, approximately 4% of RIF resistances are caused by mutations outside the rpoB gene [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Performance of the BD MAX MDR-TB assay in a clinical setting and its impact on the clinical course of patients with pulmonary tuberculosis: a retrospective before-after study

Ko,

Yoon,

Lee

2024

JYMS

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Background: Missing isoniazid (INH) resistance during tuberculosis (TB) diagnosis can worsen the outcomes of INH-resistant TB. The BD MAX MDR-TB assay (BD MAX) facilitates the rapid detection of TB and INH and rifampin (RIF) resistance; however, data related to its performance in clinical setting remain limited. Moreover, its effect on treatment outcomes has not yet been studied.Methods: We compared the performance of BD MAX for the detection of INH/RIF resistances to that of the line probe assay (LPA) in patients with pulmonary TB (PTB), using the results of a phenotypic drug sensitivity test as a reference standard. The treatment outcomes of patients who used BD MAX were compared with those of patients who did not.Results: Of the 83 patients included in the study, the BD MAX was used for an initial PTB diagnosis in 39 patients. The sensitivity of BD MAX for detecting PTB was 79.5%. The sensitivity and specificity of BD MAX for INH resistance were both 100%, whereas these were 50.0% and 95.8%, respectively, for RIF resistance. The sensitivity and specificity of BD MAX were comparable to those of LPA. The BD MAX group had a shorter time interval from specimen request to the initiation of anti-TB drugs (2.0 days vs. 5.5 days, p=0.001).Conclusion: BD MAX showed comparable performance to conventional tests for detecting PTB and INH/RIF resistances. The implementation of BD MAX as a diagnostic tool for PTB resulted in a shorter turnaround time for the initiation of PTB treatment.

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Section: Discussionmentioning

confidence: 99%