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Tongue Swab Xpert MTB/RIF Ultra Testing for Tuberculosis Using a Revised Consensus Protocol: A multi-country

Bukola Ajide1, Caitlin A Moe2,3, Jheannie Barrameda4

  • 1Zankli Research Center, Bingham University, Karu, Nigeria.

Medrxiv : the Preprint Server for Health Sciences
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Summary

Tongue swabs offer a viable alternative for tuberculosis diagnosis when sputum is unavailable. A revised protocol showed moderate sensitivity and low error rates in high TB burden countries.

Keywords:
DiagnosisDiagnostic accuracyTongue swabsTuberculosisXpert Ultra

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Area of Science:

  • Microbiology
  • Infectious Diseases
  • Diagnostics

Background:

  • Tongue swabs show promise for tuberculosis (TB) diagnosis.
  • Previous protocols using Xpert MTB/RIF Ultra had a notable rate of non-actionable results (6.1%).
  • A revised protocol was evaluated in four high TB burden countries.

Purpose of the Study:

  • To evaluate a revised tongue swab protocol for tuberculosis diagnosis using Xpert MTB/RIF Ultra.
  • To assess the diagnostic performance and error rates of the revised protocol compared to sputum-based tests.

Main Methods:

  • 1168 participants aged ≥12 years with presumptive TB were enrolled from outpatient clinics in the Philippines, South Africa, Nigeria, and Zambia.
  • Tongue swabs were processed using a revised protocol with diluted Sample Reagent (SR) and tested with Xpert Ultra.
  • Diagnostic performance was assessed against a culture-based reference standard.

Main Results:

  • The overall proportion of non-actionable results was 5.6%, with significant variation by country (South Africa: 15.4%).
  • Tongue swab sensitivity was 66.0% (95% CI 59.0-72.5) and specificity was 99.6% (95% CI 98.9-99.9).
  • The revised protocol demonstrated low error rates at most study sites.

Conclusions:

  • The revised tongue swab protocol is effective, with low error rates in most settings.
  • Tongue swabs provide moderate sensitivity and high specificity for TB diagnosis.
  • This method serves as a valuable alternative diagnostic tool when sputum collection is not feasible.