Abstract
Following the WHO's endorsement of GeneXpert MTB/RIF assay for tuberculosis diagnosis in 2010, Uganda's ministry of health introduced the assay in its laboratory network in 2012. However, assessing the quality of the result produced from this technique is one of its major implementation challenges. To bridge this gap, the National tuberculosis reference laboratory (NTRL) introduced the GeneXpert MTB/RIF proficiency testing (PT) Scheme in 2015. A descriptive cross-sectional study on the GeneXpert PT scheme in Uganda was conducted between 2015 and 2018. Sets of panels each comprising four 1ml cryovial liquid samples were sent out to enrolled participants at preset testing periods. The laboratories' testing accuracies were assessed by comparing their reported results to the expected and participants' consensus results. Percentage scores were assigned and feedback reports were sent back to laboratories. Follow up of sites with unsatisfactory results was done through "on and off-site support". Concurrently, standardization of standard operating procedures (SOPs) and practices to the requirements of the International Organization for Standardization (ISO) 17043:2010 was pursued. Participants gradually increased during the program from 56 in the pilot study to 148 in Round 4 (2018). Continual participation of a particular laboratory yielded an odd of 2.5 [95% confidence interval (CI), 1.22 to 4.34] times greater for achieving a score of above 80% with each new round it participated. The "on and off-site" support supervision documented improved performance of failing laboratories. Records of GeneXpert MTB/RIF PT were used to achieve accreditation to ISO 17043:2010 in 2018. Continued participation in GeneXpert MTB/RIF PT improves testing accuracy of laboratories. Effective implementation of this scheme requires competent human resources, facility and equipment, functional quality management system, and adherence to ISO 17043:2010.
Highlights
The GeneXpert MTB/RIF assay since its recommendation for tuberculosis (TB) diagnosis in 2010 by World Health Organization (WHO) has been used worldwide
The healthcare system in developing countries has immeasurably recognized the impacts of laboratory quality management system (LQMS) when it comes to patient care and is gradually applying it [6]
The “IF command”, “summation” and “Average” functions in excel were applied to award scores for each item tested by an individual participant and average testing turnaround time
Summary
The GeneXpert MTB/RIF assay since its recommendation for tuberculosis (TB) diagnosis in 2010 by WHO has been used worldwide. The potential benefits of the assay concerning patient management are more noticeable at the lower healthcare facilities of a country’s healthcare system than at the national level and reference testing settings. The healthcare system in developing countries has immeasurably recognized the impacts of LQMS when it comes to patient care and is gradually applying it [6] It has become necessary for all countries to strengthen the capacity of clinical laboratories and this can be achieved through setting up systems that monitor performance such as external quality assurance (EQA) [7, 8]. Assessing the quality of the result produced from this technique is one of its major implementation challenges To bridge this gap, the National tuberculosis reference laboratory (NTRL) introduced the GeneXpert MTB/RIF proficiency testing (PT) Scheme in 2015
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