免疫增强透射比浊法定量检测降钙素原的技术性能评价

Evaluation on Technical Performance of the Immune Enhanced Turbidimetric Method for the Quantitative Assay of Serum Procalcitonin

目的:评价免疫增强透射比浊法定量检测血清降钙素原(PCT)的技术性能。方法:按照NCCLS标准化的评价方案,应用全自动生化分析仪评价免疫增强透射比浊法定量检测PCT的准确度、精密度、干扰因素和线性范围。结果:平均回收率为97.4%;0.15ug/L(正常值)和17.85ug/L(高值)的批内CV均<4.5%,批间CV均<8.0%;类风湿因子浓度在200IU/m L以下、血红蛋白浓度在4.0g/L以下、三酰甘油浓度在10.0mmol/L以下和胆红素浓度在340umol/L以下时对PCT的定量检测均无显著性干扰(P>0.05);线性范围为0.00-80.00ug/L。结论:免疫增强透射比浊法具有自动化程度高、检测速度快、成本低、安全的优点,而且各项技术性能优良,因此具有较高的临床推广应用价值。

Objective： To evaluate technical performance of the immune enhanced turbidimetric method for the quantitative assay of serum procalcitonin（ PCT）. Methods： Standardized evaluation program of the NCCLS and automatic biochemical analyzer was used to evaluate the accuracy,precision,interference factors and linear range of the immune enhanced turbidimetric method for the quantitative assay of serum procalcitonin. Results： The average recovery rate was 97. 4%; the intra coefficient of variation（ CV） of 0. 15ug/L（ norma lvalues） and17. 85ug/L（ high values） were lower than 4. 5% and batch CV were lower than 8. 0%,respectively; the quantitative assay of serum PCT had no significant interference when rheumatoid factor concentration was lower than200IU/m L,hemoglobin was lower than 4. 0g/L,triglycerides was lower than 10. 0mmol/L and bilirubin was lower than 340μmol/L（ P 0. 05）; the linear range was 0. 00-80. 00ug/L. Conclusions： The immune enhanced turbidimetric method shows the advantages of high degree of automation,fast speed,low cost,safety,and excellent technical performance,so it has high value in clinical application.