Ko Dae-Hyun, Park Hae-Il, Hyun Jungwon, Kim Hyun Soo, Park Min-Jeong, Shin Dong Hoon
Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul.
Am J Clin Pathol. 2017 Oct 1;148(4):323-329. doi: 10.1093/ajcp/aqx083.
To assess the utility of reference change values (RCVs) as delta check limits.
A total of 1,650,518 paired results for 23 general chemistry test results from June 1, 2014, to October 31, 2016, were analyzed. The RCVs for each analyte were calculated from the analytical imprecision and within-subject biological variation. The percent differences between two consecutive results in one patient were categorized into one of four groups: outpatients, inpatients, emergency care, and general health care. For each, 2.5th and 97.5th percentile values were computed and compared with their RCVs. The distributions were assessed for normality using the Kolmogorov-Smirnov test.
Most of the estimated limits were larger than the corresponding RCVs and, furthermore, with notable differences across the groups. Patients in the emergency care group usually demonstrated larger delta percent values than those in the other groups. None of the distributions of the percent differences passed tests of normality when subjected to Kolmogorov-Smirnov analysis.
Comparison of estimated RCVs and real-world patient data revealed the pitfalls of applying RCVs in clinical laboratories. Laboratory managers should be aware of the limitations of RCVs and exercise caution when using them.
评估参考变化值（RCV）作为差值检查界限的效用。
分析了2014年6月1日至2016年10月31日期间23项常规化学检测结果的1,650,518对配对结果。根据分析不精密度和个体内生物学变异计算每种分析物的RCV。将同一患者连续两次结果之间的百分比差异分为四组之一：门诊患者、住院患者、急诊护理和普通医疗保健。对于每组，计算第2.5百分位数和第97.5百分位数的值，并与它们的RCV进行比较。使用Kolmogorov-Smirnov检验评估分布的正态性。
大多数估计界限大于相应的RCV，此外，各组之间存在显著差异。急诊护理组的患者通常表现出比其他组更大的差值百分比值。当进行Kolmogorov-Smirnov分析时，百分比差异的分布均未通过正态性检验。
估计的RCV与实际患者数据的比较揭示了在临床实验室应用RCV的缺陷。实验室管理人员应意识到RCV的局限性，并在使用时谨慎行事。
