Comparative study of OMNIgene®•SPUTUM reagent versus cold-chain for the transportation of sputum samples to GeneXpert®MTB/RIF testing sites in Malawi.

Background: The study was conducted in a remote sputum sample collection sites and GeneXpert® MTB/RIF testing centers to detect Mycobacterium tuberculosis in Malawi. The main purpose of the study was to evaluate whether sputum samples stored and transported with OMNIgene®•SPUTUM (OM-S) medium perform comparably to the routine cold-chain stored and transported samples for GeneXpert testing to detect Mycobacterium tuberculosis.

Methods: Two sputum samples from each of 362 tuberculosis suspects were randomly assigned to the OMNIgene treated (OM-S group) or the standard-of-care group (SOC; transported via cold chain).

The Medical Council of Malawi.

The Medical Council of Malawi (MCM) was established under the Medical Practitioners and Dentists Act No 17 of 1987. The Council however became operational in 1988. It is the sole body for registration of medical practitioners, paramedical and allied health workers in Malawi.