Evaluation of OMNIgene Sputum and Ethanol Reagent for Preservation of Sputum Prior to Xpert and Culture Testing in Uganda

J Clin Microbiol. 2019 Dec 23;58(1):e00810-19. doi: 10.1128/JCM.00810-19. Print 2019 Dec 23.

Abstract

Xpert MTB/RIF (Xpert) and culture are the most reliable methods for tuberculosis diagnosis but are still poorly accessible in many low-resource countries. We aimed to assess the effects of OMNIgene Sputum (OM-S) and ethanol in preserving sputum for Xpert and OM-S for mycobacterial growth indicator tube (MGIT) testing over periods of 15 and 8 days, respectively. Sputum samples were collected from newly diagnosed smear-positive patients. For Xpert, pooled samples were split into 5 aliquots: 3 for Xpert on days 0, 7, and 15 without additive and 2 with either OM-S or ethanol at day 15. For MGIT, 2 aliquots were tested without preservative and 2 with OM-S at 0 and 8 days. Totals of 48 and 47 samples were included in the analysis for Xpert and culture. With Xpert, using day 0 as a reference, untreated samples stored for 7 and 15 days showed concordances of 45/46 (97.8%) and 46/48 (95.8%). For samples preserved with OM-S or ethanol for 15 days compared with untreated samples processed at day 0 or after 15 days, OM-S concordances were 46/48 (95.8%) and 47/48 (97.9%), while those of ethanol were 44/48 (91.7%) and 45/48 (93.8%). With MGIT, concordances between untreated and OM-S-treated samples were 21/41 (51.2%) at day 0 and 21/44 (47.7%) at day 8. In conclusion, Xpert equally detected tuberculosis in OM-S-treated and untreated samples up to 15 days but showed slightly lower detection in ethanol-treated samples. Among OM-S-treated samples, MGIT positivity was significantly lower than in untreated samples at both time points.

Keywords: OMNIgene; Xpert; culture; tuberculosis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bacteriological Techniques / methods
  • Bacteriological Techniques / standards
  • Ethanol
  • Female
  • Humans
  • Indicators and Reagents*
  • Male
  • Microbial Sensitivity Tests / methods
  • Microbial Sensitivity Tests / standards
  • Molecular Diagnostic Techniques / methods
  • Molecular Diagnostic Techniques / standards
  • Mycobacterium tuberculosis* / drug effects
  • Mycobacterium tuberculosis* / isolation & purification
  • Preservation, Biological* / methods
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Specimen Handling* / methods
  • Sputum / microbiology*
  • Tuberculosis / diagnosis*
  • Tuberculosis / microbiology*
  • Uganda

Substances

  • Indicators and Reagents
  • Ethanol