National Reference Centre for Mycobacteriology/National Microbiology Laboratory (NRCM/NML) GeneXpert Proficiency Testing Program (GX-TB)

Detection of Mycobacterium tuberculosis complex (MTBC) and prediction of Rifampicin (RIF) resistance.

The panel consists of 4-8 simulated sputum specimens (bacterial culture spiked into glycerol stock or glycerol only) for the detection of Mycobacterium tuberculosis complex and prediction of Rifampicin (RIF) resistance for use with the Cepheid GeneXpert^R MTB/RIF Ultra assay. Characterization of panel items is performed using the Cepheid GeneXpert^R.

Clients will receive a panel shipment in the months of May and October. Clients will be given sufficient time to test and report the panel results appropriate to the test procedures.

Determination of assigned value: The assigned value is determined through pre-testing by the NRCM using the Cepheid GeneXpertR MTB/RIF Ultra assay.

Evaluation of performance: For a participant to pass, the GeneXpert results must be qualitatively identical to the expected results determined by the NRCM during pre-testing.

Report distribution: Individual participant reports will be provided to each participating laboratory within four weeks of their results submission. A final, aggregate report will be distributed to all participants within four weeks of the results deadline.

Detection and RIF susceptibility prediction testing.

No charge 

Canadian Provincial/Territorial public healthcare and hospital laboratories are eligible for participation if proficiency request is received by the NRCM within the prescribed deadline.

Participants are assigned alphanumeric codes which anonymizes their identity. All information supplied by a participant to the proficiency testing provider shall be treated as confidential. The proficiency panel will be run according to the specified procedures and without consultation with other laboratories. Final reports will be shared with participants and shall not be distributed further without permission from the panel provider. The identity of the participants will not be disclosed; however, in exceptional circumstances where proficiency testing results are provided to a third party, all information will be anonymized before dissemination, and the participants will be notified in writing.

Contact the NRCM at the email address below to request inclusion in the EQA. Participants will be required to complete the “NML Transfer Application for Pathogens and Toxins” and submit via email or via the CTLTN collaboration centre on CNPHI.

Appeals process: Participants have the right to appeal the results of any proficiency test (PT) in which they are enrolled.

Any appeals received will be acknowledged, validated, and investigated, with the outcome communicated to the participant.

If any participant would like to appeal their results, they can email this request to nml.nrcm-lnm.cnrm@phac-aspc.gc.ca.