Comparative study of OMNIgene®â€¢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®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.

Investigation of OMNIgene·SPUTUM performance in delayed tuberculosis testing by smear, culture, and Xpert MTB/RIF assays in Uganda.

OMNIgene·SPUTUM (OM-S) is a sample transport reagent designed to work with all tuberculosis diagnostics while eliminating the need for cold chain. OM-S-treated sputum samples were assayed in several tests after multiday holds. Raw sputa from 100 patients underwent direct smear microscopy, were manually split and assigned to the OM-S group [OM-S added at collection (no other processing required) and tested after 0- to 5-day holds at room temperature] or standard-of-care (SOC) group (NaOH/N-acetyl l-cysteine decontamination, all tested on day of collection). Concentrated smear microscopy, Lowenstein Jensen (LJ) culture, and mycobacteria growth indicator tube (MGIT) culture were performed. For patients with negative direct smear, a second sample was split, with SOC (raw sputum) and OM-S portions (sediment) tested in the Xpert MTB/RIF (Xpert) assay. OM-S group and SOC group results were strongly concordant on all four tests [range, 89% (MGIT)-97% (Xpert)]. OM-S MGIT, LJ, and Xpert tests were in statistical agreement with SOC MGIT as reference. OM-S specimens had lower culture contamination rates (3% vs. 10% LJ; 2% vs. 5% MGIT) but required, on average, 5.6 additional days to become MGIT-positive. The findings suggest that samples held/transported in OM-S are compatible with smear microscopy, LJ or MGIT culture, and Xpert, and perform comparably to fresh sputum samples. Larger feasibility studies are warranted.

Evaluation of OMNIgene®â€¢SPUTUM-stabilised sputum for long-term transport and Xpert® MTB/RIF testing in Nepal.

SETTING: German Nepal TB Project, National Tuberculosis Reference Laboratory, Kathmandu, Nepal. OBJECTIVE: To evaluate whether transporting samples in OMNIgene®â€¢SPUTUM (OM-S) reagent from a peripheral collection site to a central laboratory in Nepal can improve tuberculosis (TB) detection and increase the sensitivity of Xpert® MTB/RIF testing. DESIGN: One hundred sputum samples were split manually. Each portion was assigned to the OM-S group (OM-S added at collection, airline-couriered without cold chain, no other processing required) or the standard-of-care (SOC) group (samples airline-couriered on ice, sodium hydroxide + N-acetyl-L-cysteine processing required at the laboratory). Smear microscopy and Xpert testing were performed. RESULTS: Transport time was 2-13 days. Overall smear results were comparable (respectively 58% and 56% smear-negative results in the OM-S and SOC groups). The rate of smear-positive, Mycobacterium tuberculosis-positive (MTB+) sample detection was identical for both treatment groups, at 95%. More smear-negative MTB+ samples were detected in the OM-S group (17% vs. 13%, P = 0.0655). CONCLUSION: Sputum samples treated with OM-S can undergo multiday ambient-temperature transport and yield comparable smear and Xpert results to those of SOC samples. Further investigation with larger sample sizes is required to assess whether treating sputum samples with OM-S could increase the sensitivity of Xpert testing in smear-negative samples.

Translocated dogs from Nunavut and the spread of rabies.

BACKGROUND: Investigations of rabid animals that cross provincial/territorial boundaries are resource intensive and complex because of their multi-jurisdictional and multi-sectoral nature. OBJECTIVE: To describe the multi-jurisdictional responses to two unrelated rabid puppies originating from Nunavut. METHODS: A descriptive summary of the investigations following the identification of a rabid puppy in Alberta (August 2013) and another in Saskatchewan (December 2014). RESULTS: These investigations involved public health and agriculture authorities in five provinces/territories, as well as the Canadian Food Inspection Agency (CFIA). In Alberta, a puppy who became ill after being transported by air from Nunavut was euthanized and diagnosed with rabies (Arctic fox variant). Eighteen individuals were assessed for exposure to rabies; nine received rabies post-exposure prophylaxis (RPEP). An exposed household dog that tested negative was electively euthanized. In Nunavut, the rabid puppy's mother and litter mates were placed under quarantine. In Saskatchewan, another puppy became ill during transit by air from Nunavut. It was subsequently euthanized and diagnosed with rabies (Arctic fox variant). Two of three Saskatchewan individuals, including a veterinary technician, received RPEP. Two Nova Scotia residents were exposed to the puppy while in Nunavut and received RPEP. One household dog received booster vaccination, was quarantined for 45 days and remained asymptomatic. In Nunavut, the rabid puppy's mother and litter mates were not identified. In both cases, exposure to an Arctic fox was the probable source of rabies in the puppies. CONCLUSION: Translocation of dogs from the north where Arctic fox rabies is endemic poses a risk to human and animal health and may negatively impact control of rabies in Canada. There is currently no national framework to prevent inter-jurisdictional movement of potentially rabid animals in Canada.

Patient callback program: a quality improvement, customer service, and marketing tool.

The authors developed, implemented, and evaluated a callback program in which hospital patients are contacted three weeks after discharge to resolve clinical or service concerns. Of the more than 2,000 patients contacted during the initial pilot test, 6% said they had a clinical concern and were promptly directed to a physician's office. A randomized/controlled study comparing a control group of patients (who were not called) to an experimental group (called) shows that several satisfaction measures increased positively within the experimental group. The authors conclude that the Patient Callback Program contributes to more effective clinical care and to perceptions of higher customer service.