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Background: In 2010, WHO has endorsed Xpert MTB/RIF Assay for the diagnosis of tuberculosis (TB) and rifampicin
resistance tuberculosis (RR-TB). Following this recommendation, Xpert MTB/RIF Assay has been implemented in Ethiopia
since 2012. Monitoring and evaluation of Xpert MTB/RIF Assay implementation is necessary to ensure the effective and
efficient use of resources and to guide the future scale-up.
Objective: To assess the implementation Xpert MTB/RIF for the diagnosis of TB and RR-TB in Ethiopia.
Methodology: Data was collected and analyzed from 87 GeneXpert sites from May to June 2016. A structured questionnaire
was used to collect information on staff profile and trainings taken. Data was extracted from GeneXpert machine since the date
of installation from 70 GeneXpert sites. Records were reviewed from laboratory register book and from archived laboratory
request formats by using a comprehensive assessment tool to evaluate the laboratory personnel competency and clinician�s
adherence to the national algorithm.
Result: A total of 80,683 specimens were examined by using Xpert MTB/RIF Assay starting from the date of installation up
to June 2016 in 70 GeneXpert sites. Mycobacterium tuberculosis was detected in 12,422 (15.4%) of specimens. From all TB
detected results 83.75% (10,403), 12.68% (1,591) and 3.45% (428) were susceptible, resistance and indeterminate to Rifampicin
respectively. The error rate was 14.1%. There were 285 Xpert MTB/RIF Assay trained laboratory professionals at 87 GeneXpert
sites. An average of 3 trained laboratory professionals were working in each facility. At least one trained laboratory professional
was found in each facility, but untrained laboratory professionals were performing Xpert MTB/RIF Assay in 67 facilities.
National Tuberculosis Program approved Xpert MTB/RIF Assay testing algorithm was not followed in 36% of sites. Most of
the clinicians did not properly fill request papers. Standardized request formats and laboratory log books were not available in
15% and 8% of facilities, respectively. Xpert MTB/RIF Assay results were correctly recorded on the laboratory log book in 87%
of sites. Critical result (RR-TB) communication was not appropriate in 25.6% of facilities. Xpert MTB/RIF Assay test results
were not archived regularly in 47% of laboratories.
Conclusion: Detection rate of TB with the Xpert MTB/RIF Assay was low. This may be due to inappropriate eligibility screening
of the patients. Xpert MTB/RIF Assay showed an advantage for detecting RR-TB cases in peripheral laboratory level, which
is important for early detection of drug resistant cases as well as early treatment initiation. Error rate was high in comparing
with the expected standard (�3%). There was 100% Xpert MTB/RIF Assay training coverage; however, in majority of the sites
untrained laboratory professionals were performing Xpert MTB/RIF testing. This may probably have negative impact on test
results.
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