一台降钙素原POCT快速检测仪器的临床适用性评价

The Evaluation of Clinical Applicability of A Rapid Detecting Instrument for Proprocalcitonin POCT

目的通过比较雷度米特AQT90 FLEX与电化学发光法的Roche Cobas e601降钙素原(PCT)检测结果的一致性,和比较雷度米特AQT90 FLEX检测同一患者的全血及血浆样本结果的一致性,对其临床适用性进行评价。方法首先应用5个浓度梯度的临床PCT血浆和全血来评估雷度米特AQT90 FLEX的精密度;然后对Roche Cobas e601和雷度米特AQT90 FLEX检测的相同血浆样本结果,比较其一致性。最后用雷度米特AQT90 FLEX分别检测60例全血和与之对应的血浆样本,比较两种基质类型样本结果的一致性。结果雷度米特AQT90 FLEX检测5个不同PCT浓度的血浆和全血样本的不精密度(CV)分别在1.7%~9.9%和1.9%~5.8%之间,均小于10%;雷度米特AQT90 FLEX和Roche Cobas e601仪器的血浆PCT检测结果决定系数R2=0.991(P<0.001);雷度米特AQT90 FLEX对同一患者来源的全血与血浆PCT检测结果决定系数为R2=0.9989,结果配对t检验,差异无统计学意义,P<0.001。结论雷度米特时间分辨免疫荧光法检测血浆PCT结果精密度良好,与Roche Cobas e601电化学发光法的相比具有很好的一致性,并全血和血浆PCT结果一致性较好,可用于急诊和重症感染患者对于PCT的POCT检测。

Objective The clinical applicability was evaluated by comparing the consistency of Rayflex AQT90 FLEX and Roche Cobas E601 procalcitonin(PCT)based on time-resolved immunofluorescence method and the consistency of Rayflex in whole blood and plasma samples of the same patient.Methods First,the precision of Raimet AQT90 FLEX was evaluated using clinical PCT plasma and whole blood with 5 concentration gradients.Second,tracing to BRAHMS PCT LIA analysis,Roche Cobas E601 and Raimet AQT90 FLEX based on electrochemical luminescence method were used to detect the same plasma samples,and the consistency of the two results was compared.Third,60 whole blood samples and the corresponding plasma samples were tested with Leidomit AQT90 FLEX to compare the consistency of the two matrix samples.Results The accuracy coefficient of variation(CV)of 5 plasma and whole blood samples with different PCT concentrations detected by radomite AQT90 FLEX was between 1.7%-9.9%and 1.9%-5.8%,respectively,all of which were less than 10%.Correlation coefficient R2 of plasma PCT detected by radumite AQT90 FLEX and Roche Cobas e601 was 0.991(P<0.001).The correlation coefficient between whole blood and plasma PCT from the same patient was R2=0.9989 for redometer AQT90 FLEX,and the results of paired t test showed no statistical difference(P<0.001).Conclusion Compared with Roche Cobas e601 electrochemical luminescence method,the time-resolved immunofluorescence method has a good precision for PCT detection,with a good correlation and consistency with that of Roche Cobas e601 electrochemical luminescence method,and is suitable for the detection of whole blood and plasma PCT.