Recommendations for the Verification of Quantitative Molecular Hemato-Oncology Testsopen access혈액종양 정량 분자유전 검사법의 검정 권고안
- Other Titles
- 혈액종양 정량 분자유전 검사법의 검정 권고안
- Authors
- 김진주; 박성균; 조용근; 하지혜; 신새암; 이승태
- Issue Date
- Oct-2022
- Publisher
- 대한진단검사의학회
- Keywords
- Verification; Quantitative PCR; Digital PCR; Real-time PCR; Molecular diagnostic techniques
- Citation
- Laboratory Medicine Online, v.12, no.4, pp.227 - 234
- Indexed
- KCI
- Journal Title
- Laboratory Medicine Online
- Volume
- 12
- Number
- 4
- Start Page
- 227
- End Page
- 234
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/172980
- DOI
- 10.47429/lmo.2022.12.4.227
- Abstract
- Quantitative molecular genetic tests are increasingly used for the detection and quantification of target molecules or genetic alterations. When introducing a new assay into clinical laboratories, it is necessary to verify the manufacturers’ claimed performance characteristics within individual laboratories. Appropriate assay verification procedures are essential to ensure the quality of test results in clinical laboratories. This study aimed to provide recommendations for the verification of quantitative molecular genetic testing focused on the hemato-oncology field in clinical genetic laboratories. Based on a literature review, we provide recommendations for the performance verification of quantitative molecular hemato-oncology tests. The performance characteristic elements that comprise the verification procedures are presented and exemplified. These recommendations can assist individual clinical laboratories in verifying quantitative molecular diagnostic assays
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