ABSTRACT
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®â¢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). All specimens were tested at regional GeneXpert testing sites using the expectorated (raw) sputum protocol. Demographic, clinical, transport/storage and Xpert data were recorded for each specimen pair. Agreement between the SOC and OM-S groups' Xpert results was evaluated using Cohen's kappa analysis. RESULTS: Mean patient age was 42.3 years (range 2-79 years), 77% of patients were female, and 80% were HIV-positive. Mean transport/storage time was 6.7 days (range, 0-29 days). The rates of MTB positivity for the OM-S and SOC groups were comparable (11.8 and 11.2%, respectively), inter-test agreement was "very good" (κ = 0.97), and overall percent agreement was 99%. Two specimen pairs (both mucoid, one 13 days transport, one 1 day transport) had discordant Xpert results. CONCLUSION: OM-S-treated sputum specimens can undergo multi-day ambient-temperature storage as well as transport and yield Xpert results comparable to those of cold-chain-transported samples in Malawi.
Subject(s)
Refrigeration , Specimen Handling/methods , Sputum/microbiology , Tuberculosis/microbiology , Adult , Aged , Child , Child, Preschool , Female , Humans , Indicators and Reagents , Malawi , Male , Middle Aged , Mycobacterium tuberculosis/genetics , Time Factors , Young AdultABSTRACT
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. Members of Council are appointed by the Head of State. The secretariat is headed by the Registrar.
