Report of the Korean Association of External Quality Assessment Service on Clinical Mycobacteriology (2017–2018)

ABSTRACT

Rapid and correct diagnosis is essential for national tuberculosis (TB) control. A greater national concern for quality control (QC) of Mycobacterium tuberculosis (MTB) testing is required to improve the proficiency of domestic clinical laboratories using diverse testing protocols in private and public sectors. External quality assessment (EQA) is an important program accompanying internal QC in clinical TB laboratories. In Korea, the EQA program initiated in 2005 by the Korean Association of External Quality Assessment Service (KEQAS) has made remarkable progress in the harmonization of private and public sectors with governmental support since 2011. An integrative TB EQA program led by the KEQAS with financial support from the Korea Centers for Disease Control and Prevention provides optimized EQA materials for both public and private sectors. In 2017, the KEQAS implemented ‘The Next-Generation Proficiency Testing Program’ equipped with a centralized control system of QC material production and electronic data management, which increased the scale of operating programs from 46 to 54 and recruited 1,700 participants. The TB program was also expanded to provide three times EQA for private laboratories from 2 times a year. For TB EQA programs implemented via the Clinical Microbiology Subcommittee of the KEQAS, survey materials were distributed by sectional orders for tests such as acid-fast bacilli (AFB) smears, AFB culturing and identification, antituberculous drug susceptibility screening, AFB molecular diagnosis, and rapid detection of rifampin and isoniazid resistance. All survey materials were produced by sophisticated manufacturing processes and thoroughly analyzed by various commercial kits, targeted DNA sequencing, and whole-genome sequencing in pre- and post-manufacturing phases for advancement in the EQA program.