FLT3-ITD 검사의 국내 현황 조사(2021)
Status of FLT3-ITD Analysis in Korea (2021)
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초록
배경: FLT3-internal tandem duplication (ITD)는 급성골수백혈병에서 중요한 예후 인자이며 FLT3 억제제의 표적 돌연변이로, 치료 후 미세잔존질환 모니터링에 이용되기도 한다. 본 연구에서는 국내 FLT3-ITD 검사의 실태조사를 위한 온라인 설문조사를 시행하였다. 방법: 대학병원 및 3차 의료기관 검사실 책임자에게 전자 메일을 통한 설문을 시행하였다. 설문 문항은 FLT3-ITD 검사에 대한 기관별 검사 이용 및 수행 현황, 검출한계 및 정량한계 검증, 내·외부 정도관리 시행 여부, 결과보고 및 FLT3-ITD 정량 검사에 대한 의견을 포함하였다. 결과: 24개 기관의 회신을 받았다. 설문조사 결과 대부분의 기관에서 FLT3-ITD 확인 및 대립유전자 비율 확인을 위하여 절편분석법을 이용하고 있었다. 대부분의 기관에서 진단 및 경과 관찰 시 FLT3-ITD 대립유전자 비율을 보고하고 있었다. FLT3-ITD 검사에 대한 검사실 자체 검출한계 검증 및 내부정도관리를 시행하고 있었으며 국내외 외부정도관리 프로그램에 참여하고 있었다. 결론: 설문 참여 기관들은 FLT3-ITD 대립유전자 비율의 정확성 및 신뢰도를 높일 수 있는 검사 수행능 검증 및 외부정도관리 필요성에 공감하였다. 본 설문조사 결과가 향후 FLT3-ITD 검사의 표준안 설정에 바탕이 되어 궁극적으로 환자 진료에 긍정적 영향을 미치게 되길 기대한다.
Abstract
Background: FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) is a crucial prognostic factor in acute myeloid leukemia and a target mutation for FLT3 inhibitor. It is also used for monitoring minimal residual disease after treatment. In this study, we conducted an online survey to investigate the status of the FLT3-ITD test in Korea. Methods: The survey was conducted through emails to the laboratory directors at university hospitals and tertiary medical institutions. The questionnaires included four questions on the use and performance of FLT3-ITD test by each institution, one on verification of detection and quantification limits, three on internal/external quality control, three on reporting formats and one on the institutions’ opinions on the FLT3-ITD allelic ratio. Results: Replies were received from 24 institutions. As a result of this survey, it was established that most institutions use fragment analysis to confirm the presence of FLT3-ITD and its allelic ratio. Most institutions reported FLT3-ITD allelic ratios during diagnosis and follow-up. Most laboratories established self-verified detection limits, internal controls, and participated in various external quality control programs for FLT3-ITD test. Conclusions: Most survey participants agreed on the need for test performance verification and external quality control to increase the accuracy and reliability of FLT3-ITD allelic ratios. We substantiate that the results of this survey will serve as a basis for setting the standard for the FLT3-ITD test in Korea, ultimately having a positive impact on patient care.
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