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Pulmonary Tuberculosis IV01:26

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Tuberculosis, more commonly referred to as TB, is an infectious disease stemming from Mycobacterium tuberculosis. While it primarily impacts the lungs, TB can also affect other body areas. Given its severity and global impact, timely and accurate diagnosis is crucial for controlling its spread and improving patient outcomes.
Several diagnostic approaches are used to detect TB. The conventional method is the Tuberculin Skin Test (TST), also known as the Mantoux test. However, this method has...
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A global proficiency testing programme for Xpert® MTB/RIF using dried tube specimens, 2013-2015.

Katherine Klein1, Kyle DeGruy2, Zilma Rey2

  • 1Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Division of TB Elimination, Atlanta, Georgia, United States.

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Summary

A dried tube specimen (DTS) proficiency testing (PT) program effectively supports Xpert MTB/RIF external quality assessment (EQA) in resource-limited settings (RLS). This program demonstrates feasibility, demand, and improved country performance for tuberculosis diagnostics.

Keywords:
Xpert® MTB/RIFdried tube specimensexternal quality assessmentproficiency testingresource-limited settings

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Area of Science:

  • Clinical diagnostics
  • Microbiology
  • Public health laboratory science

Background:

  • Proficiency testing (PT) is crucial for ensuring accurate diagnostic results in clinical and public health laboratories.
  • The Xpert® MTB/RIF assay is widely used for tuberculosis detection, particularly in resource-limited settings (RLS).
  • A lack of low-cost PT materials hinders external quality assessment (EQA) for the Xpert MTB/RIF assay in RLS.

Purpose of the Study:

  • To evaluate the feasibility of a dried tube specimen (DTS)-based PT program for Xpert MTB/RIF EQA in RLS.
  • To assess the demand for Xpert MTB/RIF PT materials in RLS.
  • To determine if participation in a DTS-based PT program improves country-level performance.

Main Methods:

  • A voluntary EQA program using DTS-based PT material was developed and conducted between 2013 and 2015.
  • Eight PT rounds, each with five DTS samples, were distributed to participating testing sites.
  • Participant results were compared to expected results, scored, and performance reports were provided.

Main Results:

  • Program enrollment grew significantly, from 102 sites in seven countries to 441 sites in 14 countries over three years.
  • Approximately 90% of participating sites achieved satisfactory performance in each PT round.
  • Seven of the 14 countries showed an increase in satisfactory performance scores over time.

Conclusions:

  • An Xpert MTB/RIF PT program using DTS is feasible for RLS.
  • There is substantial demand for Xpert MTB/RIF PT materials in RLS.
  • Country performance in Xpert MTB/RIF testing can be improved through a DTS-based PT program.