TB-CAPT MTB/XDR Study
TB-CAPT MTB/XDR Study
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra,
 has been developed to detect additional resistance to isoniazid, fluoroquinolones and
 second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on
 primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in
 clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add
 further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR
 assay.
Inclusion Criteria:

 -  Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF
 Ultra

 Exclusion Criteria:

 -  Residual SR-sputum mix not retained or not found

 -  Patient previously included in the study

 Exclusion for diagnostic accuracy and time-to-result endpoints:

 -  Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (<2 ml)

 -  Xpert MTB/XDR unsuccessful

 -  No second / follow-up specimen received

 -  Second / follow-up specimen culture-negative, contaminated or not available

 -  Reference standard uninterpretable (phenotyping or WGS)

 -  Where phenotypic susceptibility testing results are uninterpretable, specimens
 will still be included in WGS comparison

 -  Where WGS results are uninterpretable, specimens will still be included in
 phenotypic susceptibility testing comparison