BCR::ABL1 정량 검사의 국내 현황 조사(2022)

Abstract

Background:BCR::ABL1 real-time quantitative PCR (RQ-PCR) is the optimal test for monitoring patients with chronic myeloid leukemia after treatment; however, standardization among testing institutions is required to assess molecular response. We performed an online survey to investigate the actual status and standardization of the BCR::ABL1 RQ-PCR test in Korea. Methods: The survey was provided by e-mail to the laboratory experts in molecular genetic testing at university hospitals, tertiary medical institutions, and specialized testing institutions. Questionnaires covered each institution’s BCR::ABL1 RQ-PCR test (eight questions), reporting format(six questions), verification of the lower limit of detection and quantitation (seven questions), and internal and external quality control (two questions). Results: Responses were received from 15 institutions. Every institution utilized RQ-PCR kits that were commercially available. All of them used the ABL1 gene as a reference gene and had a copy number range of at least 10,000, which is necessary for determining a deep molecular response (DMR). The majority of laboratories established their own laboratory detection limits suitable for determining a DMR. The reporting of results and internal and external quality control procedures differed by institution. Conclusions: The survey confirmed that testing institutions are implementing standardized RQ-PCR methods, but it is necessary to perform detection limit verification and internal and external quality control to improve the precision and sensitivity of the results. Standardization and guidelines are required to enhance the consistency of testing result reports across institutions.