Mind the gap: Improving the performance of the reference laboratory to end-tuberculosis in Armenia.

INTRODUCTION: A one of the step towards achieving TB related targets is to ensure early and quality diagnosis of TB in national laboratories. WHO recommends that all national reference laboratories in TB burden countries strive to reach accreditation by 2025, based on ISO15189:2012 quality management system standard. To identify gaps, progress and evaluated the evolution in implementation QMS we performed a formal assessment of the national TB reference laboratory of Armenia, as well as estimates the specific quality indicators of NRL activity. METHODOLOGY: This is retrospective study cross-sectional study using laboratory data from the National TB Reference Laboratory in Armenia. Quality Management System assessments was conducted twice a year, using TB SLMTA assessment checklist. The sputum rejection and culture rates for quality indicators are calculated and assessed monthly. RESULTS: Compared to the baseline in 2016, there was a quality improvement reflecting the progress from zero to a "one star" in 2018. Areas that reached half of the target score included document and records, management review and responsibilities, evaluation and audits. Sections as "client management and customer service" and "evaluation and audits" stagnated in terms of progress. In terms of NRL performace, all indicators improved except for culture positivity in smear negative tuberculosis. CONCLUSION: Although a quality management system was introduced in the NRL there is now an urgent need to develop and implement an adapted roadmap for Armenia. This will be vital to hasten the much-needed pace towards accreditation.

Change in TB diagnostic profile after introduction of GeneXpert MTB/RIF assay in National TB Program of Armenia, 2013-2017.

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. This study aimed to assess the change in laboratory diagnostic profile of Mycobacterium tuberculosis after introduction of the Xpert assay from 2013 to 2017. METHODOLOGY: Retrospective cohort analysis of all presumptive TB patients' records retrieved from the National Reference Laboratory database was performed. RESULTS: 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. CONCLUSION: 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.