Lab Med Qual Assur.  2021 Sep;43(3):130-137. 10.15263/jlmqa.2021.43.3.130.

Report of the Korean Association of External Quality Assessment Service on Qualitative Testing of Molecular Virology (2016–2020)

• Park , K
• Kim MN
• Sung H

• KMID: 2520820
• DOI: http://doi.org/10.15263/jlmqa.2021.43.3.130

Abstract

For this study, we reviewed the surveys on qualitative testing of molecular virology conducted by the Korean Association of External Quality Assessment Service from 2016 to 2020. For this proficiency testing, biannual quality control samples are provided and two or three samples per item are delivered to participating institutions for a trial. During the study period, the number of participating institutions had decreased for cytomegalovirus (CMV); was unchanged for human immunodeficiency virus type 1 (HIV-1); and had increased for Epstein-Barr virus (EBV), human papillomavirus (HPV), and respiratory viruses comprising adenovirus, influenza virus, parainfluenza virus, and respiratory syncytial virus (RSV). Only one or two institutions had incorrect results for CMV, EBV, HPV, and HIV over the 5-year period, except for one CMV sample in the second trial in 2019, for which four institutions reported false-negative results. In 2016, respiratory virus proficiency testing showed 10 (14%) and 30 (41%) institutions with false responses to influenza and RSV. In 2017, 22 institutions (24%) responded with false-negative results for adenovirus in the first trial, and 30 institutions (33%) responded with false-positive results due to contamination during sample preparation in the second trial. Some unacceptable results were likely due to clerical errors and the low sensitivity of laboratory-developed tests. In conclusion, this report suggests that proficiency testing is helpful for improving laboratories’ performances in qualitative molecular virology test reporting and highlights the importance of adequate quality control material production.

Keyword

Proficiency testing; Quality assurance; Molecular virology; Qualitative testing