Field Testing of OMNI-gene TB Sputum Optimizer in Malawi

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Presentation transcript:

Field Testing of OMNI-gene TB Sputum Optimizer in Malawi The 47th Union World Conference on Lung Health October 26-29, 2016. Liverpool, UK By Wondwossen Asefa (Project HOPE)

Background and Objective One of challenges to ensuring accurate TB diagnosis is transporting sputum samples to diagnostic laboratories without destroying the integrity of the sample. TB diagnostic laboratories usually necessitate to either process the specimen shortly after collection or store it at very low temperature to inhibit the growth of contaminating micro-organisms. OMNIgene® is a reagent designed for liquefying and decontaminating sputum samples at the point-of-collection or in the lab while preserving MTB viability for at least 8 days at ambient temperatures (up to 40 0C). Objective To evaluate whether OMNIgene-SPUTUM can maintain quality of sputum samples transported at ambient temperature from peripheral collection centers to centralized GeneXpert testing centers for improved case detection.

Methodology This was a quantitative comparative study design: Two samples from the enrolled study subjects were randomized to OMNIgene treated or Standard of Care (SOC) arm. Both samples tested according to Xpert MTB/RIF package insert H.2 for raw sputum : Samples were treated directly with SR buffer without centrifugation. The study was conducted in seven district of Malawi, Nov 2015- February 2016. Sample size= 377 (d=5%, CI=95% and p=50%) Prior ethical clearance from National Health Sciences Research Committee (NHSRC) of Malawi was obtained.

Results A total of 362 sputum samples were collected (96%); of which, 49 (13.5%) of the samples were excluded due to gross incompleteness. Compatibility of OMNIgene-SPUTUM with Xpert MTB/RIF assay protocol H.2 (raw sputum) was found with 98% of concordance. Inter-rater agreement between the two procedures using Cohen’s kappa index was k=0.968 (p=0.000). Xpert MTB-Rif result Sputum (SOC) N= 313 OMNigene-SPUTUM N= 313 Positive 35 (11.2%) 37 (11.8) Negative 270 269 Error 6 Invalid 1 No result

Conclusion and recommendation More ( additional 2) bacteriologically confirmed mycobacterium tuberculosis cases were identified from OMNI-gene treated sputum specimen (intervention group) OMNIgene-SPUTUM treatment of samples did not cause an increase in Xpert MTB/RIF errors or invalid test results OMNI-gene sputum sample optimizer is good alternative solution to store and transport sputum specimen from peripheral or remote sputum collection points to GeneXpert diagnostic centers

Acknowledgements MOH-Malawi (National TB Control Program) STOP-TB Partnership (TB-REACH) DNA-GENOTEK National Health Sciences Research Committee (NHSRC) of Malawi