DEVELOPMENT OF THE NATIONAL EXTERNAL QUALITY ASSESSMENT (EQA) PROGRAM OF LABORATORY TESTING FOR COVID-19 (DETECTION OF SARS-COV-2 RNA) BY POLYMERASE CHAIN REACTION (PCR)
DOI:
https://doi.org/10.31082/1728-452X-2021-225-3-2-7Keywords:
laboratory diagnostics COVID-19, SARS-CoV-2, External Quality Assurance.Abstract
External Quality Assurance (EQA) of tests performed by diagnostic laboratories is one of the most important components of accuracy and effectiveness of laboratory diagnosis. Successful participation of laboratories in EQA scheme can provide objective evidence about proficiency of testing team and is a unique source of information that can hardly be obtained elsewhere. In Kazakhstan, PCR testing for COVID-19 is provided by public and private laboratories. To obtain uniform information, the current quality of laboratory diagnostics in the country was reviewed by analyzing retesting results and on-site laboratory performance assessment.
Purpose of the study. Development of a National Program for External Assessment of the Quality of Laboratory Research in the Diagnostics of COVID-19 to raise the quality of laboratory tests, ensure the reliability of test results, and improve laboratory diagnostics.
Material and methods. Reports, background information and check-list data from the Reference Laboratory for Viral Infections (RL) within the branch Research-to-Practice Center for Epidemiological Expertise and Monitoring under National Public Health Center, MoH, and materials of international EQA conducted by the World Health Organization were used in the analysis.
Results and discussions. National EQA was conducted by means of retesting and on-site performance appraisal of laboratories. According to retesting results in 2021, the comparability of testing results on country average was 98.6%. It appears from the results of on-site laboratory performance assessment that all laboratories have permits to provide PCR testing for COVID-19 and the majority of them conform with biosafety requirements in PCR section, as well as sanitary and epidemiological requirements specified in regulations. However, non-conformities were observed in some laboratories. The World Health Organization provided EQA by proficiency testing. According to the results of international EQA scheme, the average proportion of matches in proficiency testing in Kazakhstan was 91.4%.
Conclusion. Acknowledging importance of laboratory component in early prevention of SARS-CoV2, we believe that EQA scheme will make it possible to early identify problems in laboratory practice and respond through corrective and preventive actions. At the same time, it is necessary to make amendments to existing regulations in Kazakhstan to improve the National EQA by engaging public health and private laboratories into quality assurance of laboratory diagnostics of COVID-19. This would enable reliability assessment of methods, materials and equipment, staff competencies, and will facilitate further capacity-building of the laboratories.
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