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Introduction: Measuring performance indicators is a critical element of Quality Assurance for
any diagnostic test as well as an ISO 15189 requirement. Targets should be set for all indicators
monitored, and any unexplained change in quality indicators, such as an increase in error rates, a
change in MTB positivity rate or Rifampicin resistance rate, or a significant change in volume of
tests conducted, should be documented and investigated.
Objective: The aim of this study was to establish and implement Quality indicators for
Mycobacteriology Laboratory at PHIL, Hawassa, South Ethiopia from October 27, 2020 to
February30, 2021.
Method: A cross-sectional study was conducted on 229 samples from presumptive TB cases
for Gene Xpert MTB/Assays and 439 specimens for MGIT and LJ Culture, to assess the Quality
Indicators status of each technique. The specimens were received from Facilities under the
referral network to the Mycobacteriology and processed, examined by the Mycobacteriology Lab
as per the standard operating procedure and Data were tracked using real-time Gene Xpert
software, Laboratory registers, and standardized formats. Fulfillment for Quality indicators was
evaluated.
Results: Of the 239 sputum sample processed by the Gene Xpert MTB/Assay, the
M.Tuberculosis detection rate among presumptive TB cases was 37/229(16.2%), Rifampicin
resistant tuberculosis was 1(2.7%) and the overall unsuccessful rate was 4/229(1.7%).
The mean TAT for Gene Xpert MTB/RIF assay result is 21hrs with SD±6hours.
While ,439 sputum specimens processed using both LJ and BACTEC MGIT culture methods the
recovery rate for smear positive samples for both LJ and BACTEC MGIT Culture methods was
19/35(54.3%), whereas the recovery rate for smear negative samples was 19/369(5.1%) and
16/(4.2%) for BACTEC MGIT 960 and LJ methods respectively. Specimen rejection rate
calculated was 0.93% (4/439).The mean TAT of mycobacteria from smear positive samples was
14.8 and 35.6, with SD±7.25 and 9.55 days for BACTEC MGIT 960 and LJ methods
respectively. TAT for smear negative samples was 18.9 and 38.7 days for BACTEC MGIT 960
and LJ methods, with SD±3 and 5days respectively. The Contamination rates were
45/439(10.2%) and 42/439(9.6%) for liquid and solid cultures respectively. Non-Tuberculosis
Mycobacteria detection rate was 6/439 (1.4%)
Conclusion: Majority of the quality indicators are within target for specimen rejection,
turnaround times for result delivery, Non-tuberculosis mycobacteria detection rates, Xpert MTB
detection, and unsuccessful rates, whereas demands due attention to improve those indicators
which were out of the target, low recovery rate, culture contamination rates and turnaround time
to smear negative culture results. |
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