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Evaluation of TBMDR and XDRA for the rapid detection of multidrug resistant and extensively drug resistant tuberculosis

Eunjin Cho*, Su jin Lee§, Jiyoung Lim§, Dong sik Kim§, Namil Kim§, Han oh Park§ , Ji-im Lee*, Eunsoon Son*, and Jongseok Lee* 

* International Tuberculosis Research center: 236 Gaposunhwan-ro, Masanhappo-gu, changwon-si, Gyeongsangnam-do, Republic of Korea,

§ BIONEER: 8-11, Munpyeongseo-ro, Daedeok-gu, Daejeon 34302, Republic of Korea 

The purpose of this evaluation is to validate qPCR kit for MDR-TB and XDR-TB detection. AccuPower® TB&MDR real-time PCR kit detects MDR-TB, and AccuPower® XDR-TB Real-time PCR Kit-A detects XDR-TB.

The 241 MTB isolates were used to compare MGIT and qPCR results. The results were analyzed by the Sanger sequencing method.

INH resistance detection results showed TBMDR sensitivity of 84.6% (95%CI 77.24-90.34%) with a specificity of 99.1% (95%CI 95.04-99.98%), and the RIF resistance detection showed a sensitivity of 95.9% (95% CI 91.1-100%) with 91.7% (95% CI 87.1-96.3%) specificity.

FQ resistance detection results showed XDRA sensitivity of 81.3% (95%CI 77.2-85.4%) with a specificity of 95.8% (95%CI 91-100%), and the SLIDs resistance detection showed a sensitivity of 67.7% (95% CI 57.39-76.90%) with 100% (95% CI 97.47-100%) specificity.

The concordances shown in the sequencing results were RIF 99.2%, INH 95.4%, FQ 96.6%, and SLID 99.2%, respectively.