血清降钙素原实验室检测现状分析

Analysis of the current detection status of serum procalcitonin

目的:通过对卫生部临检中心2017年降钙素原(PCT)的两次室间质量评价(EQA)结果了解我国临床实验室的检测现状,为其质量改进提供依据。方法:分别按检测方法和试剂厂家对实验室分组,对实验室数≥18家的各组原始数据进行分析,比较其中位数、变异系数(CV)等。结果:按检测方法分组时,在第一次EQA活动中,各方法组检测0. 05μg/L、0. 50μg/L、2. 00μg/L及10. 00μg/L 4个医学决定水平处(Xc)的EQA样品时,其中位数的最大值与最小值的比值分别为5. 83、6. 73、4. 78和3. 59,相同方法实验室间检测结果的CV为15. 53%～1 090. 00%;而第二次EQA活动中,其中位数的最大值与最小值的比值则分别为5. 17、5. 46、5. 04和3. 18,相同方法实验室间检测结果的CV为6. 96%～1 379. 45%。按试剂厂家分组时,各试剂组在第一次EQA活动中各Xc处的中位数的最大值与最小值的比值分别为6. 17、3. 83、4. 45和5. 72,相同试剂实验室间检测结果的CV为8. 20%～1 126. 32%;在第二次EQA活动中,各试剂组中位数的最大值与最小值的比值则分别为5. 67、5. 27、5. 55和10. 02,相同试剂实验室间检测结果的CV为7. 35%～1 225. 00%,且除0. 05μg/L外,其余Xc处的及格率均明显升高,差异具有统计学意义(P <0. 05);而具有溯源性的3种试剂在两次EQA活动中,其中位数的差异均<50. 00%。结论:无溯源性的检测系统之间检测结果缺乏可比性,各系统需加强溯源性的建立与管理;新的检测系统应用于临床时必须进行性能验证,并建立自己的参考区间及诊断Cut-off值以正确指导临床的诊疗工作,并通过EQA活动对质量持续改进。

Objective: To study the procalcitonin( PCT) status of detection of clinical laboratory,through analyzing the ministry of health visit center of 2 external quality assessment( EQA) 2017,and to provide the basis for the quality improvement. Methods: According to the detection method and the group of reagent manufacturers,the median,the coefficient of Variance( CV) and so on were analyzed which the test data in each group great than or equal to the raw data of 18 families. Results: According to the test method,the first time in EQA,the ratio of the median of the maximum and the minimum was 5. 83,6. 73,4. 78 and 5. 83 respectively,the medical decision level( Xc) was 0. 05 μg/L,0. 50 μg/L,2. 00 μg/L and 10. 00 μg/L,the CV was 15. 53% ~ 1 090. 00%. In the second EQA,the ratio of the median maximum and the minimum value was 5. 17,5.46,5. 04 and 3. 18 respectively,and the CV was 6. 96% ~ 1 379. 45%. According to reagent factory,the first time,the median of the ratio of the maximum and the minimum was 6. 17,3. 83,4. 45 and 6. 17 respectively in the Xc,the CV was 8. 2% ~1 126. 32%; In the second EQA,the ratio was 5. 67,5. 27,5. 55 and 10. 02 respectively,and the CV was 7. 35% ~ 1 225%.The pass rate was significantly elevated in the Xc except 0. 05 μg/L,which had significant difference( P < 0. 05). In the two EQA activities,the median difference between the three traceability reagents was less than 50. 00%. Conclusion: There is no comparison between the detection system of the no traceability system,and all systems need to strengthen the establishment and management of traceability. The verification of a new detection system must be performed and establish its own reference range,also the Cut-off values when it is used for clinical work,which guide the clinical diagnosis and treatment work,the EQA activities can provide a continuous improvements.