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Usefulness of Reference Change Values for Delta Check Limits in Clinical Laboratory Testing

임상검사와정도관리 2020년 42권 3호 p.121 ~ 129
이승옥, 손정옥, 권혁, 박강훈, 유경기, 한은희, 제갈동욱, 김영식,
소속 상세정보
이승옥 ( Lee Seung-Ok ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
손정옥 ( Son Jung-Ok ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
권혁 ( Kwon Hyuk ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
박강훈 ( Park Kang-Hoon ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
유경기 ( Yu Gyong-Gi ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
한은희 ( Han Eun-Hee ) - Catholic University College of Medicine Incheon St. Mary’s Hospital Department of Laboratory Medicine
제갈동욱 ( Jekarl Dong-Wook ) - Catholic University College of Medicine Department of Laboratory Medicine
김영식 ( Kim Yeong-Sic ) - Catholic University College of Medicine Department of Laboratory Medicine

Abstract


Background: In this study, the usefulness of within-subject biological coefficient of variation (CVI) and reference change values (RCVs) for delta check limits were investigated by comparing the population distributionbased delta check limits.

Methods: For six tests, including aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transferase, glucose, creatinine, and hemoglobin, the RCV95%, RCV99%, and RCV99.9% delta limits were obtained. The nonparametric 95% and 99% delta limits were obtained from the population distribution of the delta percentage difference of the health examination group (January 2014 to December 2018) and the outpatient and inpatient groups (January to December 2018). Delta check alerts (%) in total and all three subgroups were examined according to the five different delta check limits. Additionally, we analyzed the correlation of the median CVI estimates with population-delta check limits for the six tests.

Results: The delta percentage difference of the six tests showed a nonnormal distribution, and median value significantly differed among the health examination, outpatient, and inpatient groups (all, P <0.001). The overall delta check alerts of six tests decreased in the order of RCV95%, RCV99%, and RCV99.9%, population distribution -95%, and -99% delta limits; the proportion of the health examination group gradually decreased and that of inpatients increased. A good correlation was observed between median CVI (range, 2.7% to 10.1%) and population distribution delta limits (r =0.96 to 0.99).

Conclusions: The RCV delta check limits should be applied differently depending on the health and disease group. CVI can be useful for estimating the delta check limits of the population.

키워드

Reference change value; Delta check limits; Quality control; Biological variation

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