The GenoType® MTBDRsl test for resistance to second-line anti-tuberculosis drugs

  • Protocol
  • Diagnostic

Authors


Abstract

This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows:

To obtain summary estimates of the diagnostic accuracy of GenoType® MTBDRsl for detection of resistance to the fluoroquinolones in patient specimens or culture isolates confirmed as TB positive.

To obtain summary estimates of the diagnostic accuracy of GenoType® MTBDRsl for detection of resistance to second-line injectable drugs in patient specimens or culture isolates confirmed as TB positive.

To obtain summary estimates of the diagnostic accuracy of GenoType® MTBDRsl for detection of XDR-TB in patient specimens or culture isolates confirmed as TB positive.

Purpose of index test: GenoType® MTBDRsl used as an initial test replacing phenotypic culture-based DST as the initial test.

We plan to investigate heterogeneity in relation to the reference tests (genetic sequencing, culture-based DST, and culture-based DST followed by genetic sequencing), as well as by type of testing (indirect or direct). We also plan to investigate heterogeneity in relation to HIV status, conditions of the specimens (fresh or frozen, volume of specimen) and patient population (patients suspected of having MDR-TB or XDR-TB).