胶乳增强免疫比浊法检测降钙素原的方法评价

Evaluation of latex enhanced immunoturbidimetry assay for determination of procalcitonin

目的评价胶乳增强免疫比浊法（LEITA）测定血清降钙素原（PCT）水平的临床应用价值。方法依据美国临床实验室标准化委员会（NCCLS）指南对LEITA测定PCT进行精密度（RSD）、线性范围及干扰试验验证,并与电化学发光免疫分析法（ECLI）进行比较。结果 LEITA测定PCT批内RSD〈7.33%,批间RSD〈9.26%;血清PCT在0.01~79.80μg/L范围内检测线性良好（y=0.9331x-0.3093,r=0.9997）。LEITA与ECLI具有较好相关性（r=0.9995,P〈0.01）。结论 LEITA测定PCT能满足临床检验要求。

Objective To evaluate the clinical availability of latex enhanced immunoturbidimetry assay（LEITA） for determination of serum procalcitonin（PCT） level. Methods Based on the National Committee for Clinical Laboratory Standards（NCCLS）, the relative standard deviation（RSD）, linearity and interference of LEITA were compared with electrochemiluminescent immunoassay（ECLIA） for detection of serum PCT level. Results The coefficients of variation of intra- and inter-assay for PCT detection were 7.33% and 9.26%, respectively. There was a linear relationship at PCT concentrations of 0.01~79.80 μg/L（y=0.9331x-0.3093, r=0.9997）. The results of PCT showed a significant correlation between LEITA and ECLIA（r=0.9995,P〈0.01）. Conclusion LEITA method for the PCT determination was in line with the NCCLS standard.LEITA can meet the requirements of clinical testing for PCT detection.