Comparative Evaluation of GeneXpert MTB/RIF Ultra and GeneXpert MTB/RIF for Detecting Tuberculosis and Identifying Rifampicin Resistance in Pars Plana Vitrectomy Samples of Patients with Ocular Tuberculosis.

BACKGROUND

Xpert MTB/RIF Ultra (Ultra) was evaluated for the first time on Ocular tuberculosis (OTB) samples and compared with Xpert.

METHODS

Seventy five vitreous fluid samples (3 confirmed OTB, 47 clinically suspected OTB, and 25 controls) were subjected to Ultra, Xpert and Multiplex-PCR and compared against culture, composite reference standard (CRS), and gene sequencing.

RESULTS

The sensitivity of Ultra was 50% in diagnosing OTB (100% against culture and 46.8% against CRS). The overall sensitivity of Xpert and MPCR was 16% and 72%, respectively. Xpert missed three culture-positive cases and MPCR detected additional 11. Ultra and Xpert missed two and four cases of RifR, respectively. A total of 13(59%) cases were reported 'trace' by Ultra in which RifR could not be evaluated.

CONCLUSION

Ultra outperformed Xpert in diagnosing OTB. The advantage of Ultra's simultaneous RifR detection is lost since the trace bacterial loads in the specimens cause indeterminate results of RifR testing. OTB: Ocular tuberculosis; Ultra: Xpert MTB/RIF Ultra; Xpert: Xpert MTB/RIF, MPCR: multiplex polymerase chain reaction; NAATs: Nucleic acid amplification tests; MLAMP: multitargeted loop-mediated isothermal amplification; PPV: positive predictive value; NPV: negative predictive value; EPTB: extrapulmonary tuberculosis; VF: vitreous fluid; DNA: deoxyribonucleic acid; ATT: antitubercular therapy; RifR: Rifampicin resistance; RifS: Rifampicin susceptible; RifI: Rifampicin indeterminate.