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논문 기본 정보

자료유형
학술저널
저자정보
Loh Tze Ping (Department of Laboratory Medicine National University Hospital Singapore Singapore) Tan Rui Zhen (Engineering Cluster Singapore Institute of Technology Singapore Singapore) Lim Chun Yee (Engineering Cluster Singapore Institute of Technology Singapore Singapore) Markus Corey (Flinders University International Centre for Point-of-Care Testing Flinders Health and Medical Rese)
저널정보
대한진단검사의학회 Annals of Laboratory Medicine Annals of Laboratory Medicine 제42권 제5호
발행연도
2022.9
수록면
597 - 601 (5page)
DOI
10.3343/alm.2022.42.5.597

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초록· 키워드

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This study describes an objective approach to deriving the clinical performance of autoverification rules to inform laboratory practice when implementing them. Anonymized historical laboratory data for 12 biochemistry measurands were collected and Box-Cox-transformed to approximate a Gaussian distribution. The historical laboratory data were assumed to be error-free. Using the probability theory, the clinical specificity of a set of autoverification limits can be derived by calculating the percentile values of the overall distribution of a measurand. The 5th and 95th percentile values of the laboratory data were calculated to achieve a 90% clinical specificity. Next, a predefined tolerable total error adopted from the Royal College of Pathologists of Australasia Quality Assurance Program was applied to the extracted data before subjecting to Box-Cox transformation. Using a standard normal distribution, the clinical sensitivity can be derived from the probability of the Z-value to the right of the autoverification limit for a one-tailed probability and multiplied by two for a two-tailed probability. The clinical sensitivity showed an inverse relationship with between-subject biological variation. The laboratory can set and assess the clinical performance of its autoverification rules that conforms to its desired risk profile.

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