Abstract

In 2013, the National Tuberculosis (TB) Program of Armenia introduced GeneXpert MTB/RIF (Xpert) assay to address World Health Organization (WHO) target of 80% (2020) of notified new and relapse TB cases to be tested with WHO recommended rapid diagnostic methods. This study aimed to assess the change in laboratory diagnostic profile of Mycobacterium tuberculosis after introduction of the Xpert assay from 2013 to 2017. Retrospective cohort analysis of all presumptive TB patients' records retrieved from the National Reference Laboratory database was performed. This study showed increased trend of Xpert coverage for suspected TB cases from 25% in 2013 to 86% in 2017 which is in line with WHO TB global strategy's target of 80% in 2020. In 4.7% cases, Xpert tested positive while microscopy showed negative results. There was also an improved detection of Rifampicin resistance with increased concordance from 99.1% to 99.4% and decreased discordance from 6.7% to 1.4% between culture and Xpert results. Armenia has achieved the 2020 target; in terms of utilizing the GeneXpert it is on track to achieve the End TB strategy target of 100% by 2025. The next step of this research will be assessment of the impact of GeneXpert and other TB tests utilization on the treatment outcomes in Armenia.

Highlights

  • In 2013, the National Tuberculosis (TB) Program of Armenia introduced GeneXpert MTB/RIF (Xpert) assay to address World Health Organization (WHO) target of 80% (2020) of notified new and relapse TB cases to be tested with WHO recommended rapid diagnostic methods

  • The aim of this study was to assess the change in laboratory diagnostic profile of Mycobacterium tuberculosis after introduction of the WHO endorsed Xpert MTB/RIF molecular assay in Armenia from 2013 to 2017

  • Among the presumptive TB cases registered in National TB Reference Laboratory (NRL) from 2013 to 2017, 89% were males

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Summary

Introduction

In 2013, the National Tuberculosis (TB) Program of Armenia introduced GeneXpert MTB/RIF (Xpert) assay to address World Health Organization (WHO) target of 80% (2020) of notified new and relapse TB cases to be tested with WHO recommended rapid diagnostic methods. In 4.7% cases, Xpert tested positive while microscopy showed negative results. Laboratory methods conventionally used for active TB detection are sputum smear microscopy and culture-based tests [1]. It was vital to improve and possibly replace microscopy with simpler, more affordable and more accurate diagnostic methods. To address this challenge, new molecular methods were developed, including GeneXpert (Xpert) [8]

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