OMNIgene.SPUTUM for Transporting Sputum in Ambient Temperature for Tuberculosis Testing: Bangladesh Experience

Abstract

Background: Performance of OMNIgene.SPUTUM (OM-S) for transporting sputum was evaluated.Methods: This exploratory study was conducted during January-December 2019 at four near and one distant healthcare-facilities of Dhaka. Smear-positive pulmonary TB patients’ sputa were collected, divided into ‘OM-S untreated’ and ‘OM-S treated’ portions, and transported to icddr,b lab, Dhaka, on same-day from near-sites, and through courier from distant-site for smear-microscopy, culture, and Xpert MTB/RIF (Xpert) testing. Subset of ‘OM-S treated’ sample was tested with Xpert without centrifugation. Test results of all portions were compared in between.Results: Total 444 participants were enrolled (near-sites:198, distant-site: 246). All test results were comparable in both portions for near-sites. For distant-site, smear-microscopy’s positivity was reduced by 4.1% in ‘OM-S treated’, Xpert showed 100% concordance in both portions, and culture was higher in ‘OM-S treated’ than ‘OM-S untreated’ (92.3% vs 89.4%; p=0.288). Primary contamination rate in ‘OM-S treated’ was lower than ‘OM-S untreated’ (9.8% vs 2.0%; p<0.05). For all sites, median (IQR) time-to-culture positivity was 35 (28, 42) days in both portions. Xpert positivity was 99% concordant in ‘OM-S treated’ regardless of centrifugation.Conclusions: OM-S is safe and useful for sputum transportation, and can be used for multidrug-resistant TB patients’ follow-up. Further studies can validate findings and assess cost-effectiveness.

Note:
Funding declaration: This study was produced with the support of the United States Agency for International Development (USAID) under the terms of USAID’s Research for Decision Makers (RDM) Activity cooperative agreement no. AID-388-A-17-00006. Views expressed herein do not necessarily reflect the views of the U.S. Government or USAID.

Conflict of Interests: The authors declared no conflict of interest involved in this study.

Ethical Approval: We interviewed participants after taking informed written consent from adult (≥18 years old) participants, and assent from both participants and their guardians for 15-17 years age group. The research protocol (PR-17098) was approved by the Institutional Review Board of icddr,b constituting Research Review Committee and Ethical Review Committee.

Keywords: OMNIgene.SPUTUM, sputum transportation, Bangladesh, room temperature, Tuberculosis