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The performance of the BluePoint MycoID  plus  kit (Bio Concept Corporation, Taichung, Taiwan), which was designed to simultaneously detect  Mycobacterium tuberculosis  (MTB), rifampin- and isoniazid-resistant MTB, and nontuberculous mycobacteria (NTM) was first evaluated with 950 consecutive positive cultures in  Mycobacterium  Growth Indicator Tube (MGIT) system (BACTEC, MGIT 960 system, Becton-Dickinson, Sparks) from clinical respiratory specimens. The discrepant results between kit and culture-based identification were finally assessed by 16S rRNA gene sequencing and clinical diagnosis. The accuracy rate of this kit for identification of all  Mycobacterium  species was 96.3% (905/940). For MTB identification, the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the kit were 99.7%, 99.3%, 99.0% and 99.8%, respectively. For rifampicin-resistant MTB identification, the sensitivity, specificity, PPV, and NPV of the kit were 100.0%, 99.4%, 91.3%, and 100.0%, respectively, while the corresponding values of isoniazid-resistant MTB identification were 82.6%, 99.4%, 95.0%, and 97.6%, respectively. In identifying specific NTM species, the kit correctly identified 99.3% of  M .  abscessus  (147/148) complex, 100% of  M .  fortuitum  (32/32),  M .  gordonae  (38/38),  M .  avium  (39/39),  M .  intracellulare  (90/90),  M .  kansasii  (36/36), and  M .  avium  complex species other than  M .  avium  and  M .  intracellulare  (94/94). In conclusions, the diagnostic value of the BluePoint MycoID  plus  kit was superior to culture method for recoveries and identification of NTM to species level. In addition, the diagnostic accuracy of BluePoint MycoID  plus  kit in MTB identification was similar to conventional culture method with high accuracy rate of rifampicin-resistant  M .  tuberculosis  identification.

plos one

Performance Assessment of the BluePoint MycoID Plus Kit for Identification of Mycobacterium tuberculosis, Including Rifampin- and Isoniazid-resistant Isolates, and Nontuberculous Mycobacteria