基于钾、钠、总钙项目探讨异常检验结果复查前后的一致性

Consistency of abnormal results before and after re-determinations based on K+,Na+and total calcium determinations

目的以钾、钠、总钙测定为例,探讨临床检验中异常结果复查前后的一致性与可接受性。方法分别选取钾、钠、总钙项目接近医学决定水平与危急值水平的样本,评估批内、批间变异系数(CV)。依据美国临床实验室标准化协会(CLSI)EP9-A3文件,对各项目异常结果复查前后数据的相关性以及在医学决定水平与危急值处的结果偏差进行评估;选取2019年1—6月钾、钠、总钙的异常检测结果,与复查结果进行比较。结果钾、钠、总钙在不同医学决定水平或危急值处的批内、批间CV均低于我国卫生行业标准WS/T 403—2012中规定的允许CV。将钾、钠、总钙医学决定水平值和危急值分别代入根据钾、钠、总钙项目复查前、后数据得出的回归方程,并计算偏差,偏差均低于美国临床实验室修正法案(CLIA'88)规定的允许总误差(TEa)的1/3(1/3TEa)。钾项目异常结果复查前后偏差<1/3TEa的占99.6%,>1/3TEa占0.4%;钠项目偏差<1/3TEa的占85.7%,>1/3TEa的占14.3%;总钙项目偏差<1/3TEa的占84.1%,>1/3TEa的占15.9%。结论尽管检测系统性能优良,但仍有一些异常结果复查前后不一致,偏差不为临床所接受。建议,对于检验项目异常结果必须复查,并确保结果准确后才能发出报告,以免影响临床决策。

Objective To investigate the consistency and acceptability of abnormal results before and after re-determinations in clinical laboratory based on K^(+),Na^(+)and total calcium determinations.Methods The samples of abnormal K^(+),Na^(+)and total calcium concentrations close to clinically significant and critical levels were collected to evaluate the within-run and between-run coefficient of variation(CV).According to the Clinical and Laboratory Standards Institute(CLSI)EP9-A3,the correlation between abnormal results before and after re-determinations was evaluated,and the deviation of results in clinically significant and critical levels was subsequently analyzed.Based on the methods aforementioned,the differences of abnormal K^(+),Na^(+)and total calcium levels before and after re-determinations were further assessed from January to June 2019.Results The CV of K^(+),Na^(+)and total calcium concentrations close to clinically significant and critical levels were less than the allowable CV in WS/T 403—2012,the health industry standard of the People's Republic of China.The medically determined levels and critical values of K^(+),Na^(+)and total calcium were respectively substituted into the linear equations obtained from the results before and after re-determinations to calculate the deviation,and the acceptable deviation was less than 1/3 of the allowable total error(TEa)of the Clinical Laboratory Improvement Amendment of 1988(CLIA'88).In all the samples with abnormal results,the percentages of<1/3TEa-deviations were 99.6%,85.7%and 84.1%for K^(+),Na^(+)and total calcium concentrations,respectively.The percentages of>1/3TEa-deviations were 0.4%,14.3%and 15.9%,respectively.Conclusions Although the performance of the modern determination system is excellent,there is always some inevitably unacceptable results with high deviations.Therefore,the abnormal results in clinical determinations should be re-determined to ensure the accuracy of results before reporting,and to avoid unnecessary troubles caused by abnormal results affecting clinical decisions.