摘要
目的对降钙素原(PCT)检测的胶乳增强免疫比浊法进行性能评估,并与化学发光法进行比较分析,判断其临床可接受性。方法按照美国临床实验室标准化协会(CLSI)的标准,对降钙素原(PCT)检测的胶乳增强免疫比浊法进行精密度、线性、抗干扰及方法学评价,并与化学发光法进行比较。结果在0.5μg/L和2.0μg/L医学诊断水平,胶乳增强免疫比浊法的批内和日间CV值分别<5.0%和2.0%。检测线性范围为0.05μg/L^60μg/L,线性范围内偏差<5.0%。胶乳增强免疫比浊法与化学发光法具有良好的相关性,平均偏倚分别为0.4μg/L和0.6μg/L,其差异无统计学意义。胶乳增强免疫比浊法抗干扰性强,标本总胆红素(≤600μmol/L)、血红蛋白(≤400 mg/dl)、三酰甘油(≤1 000 mg/dl)、类风湿因子(≤200 IU/ml)对PCT的测定均无影响。结论 PCT胶乳增强免疫比浊法与化学发光法具有良好的相关性,因其检测时间短,费用相对较低,因此具有良好的市场前景。
Objective To evaluate the performance of particle- enhanced immunoturbimetric assay（ PETIA） on procalcitonin（ PCT）,compare it with chemiluminescence method and evaluate its clinical acceptability. Methods According to clinical and laboratory standards institute（ CLSI） standards,the precision,linearity,anti- interference,methodology correlation and clinical application of PETIA on PCT were analyzed in this study and compared with chemiluninescence method. Results The within- run and day- to- day CVs was less than 5. 0% and 2. 0% respectively at two medical diagnosis level（ 0. 5 μg / L and2. 0 μg / L）. Linear range was from 0. 05 μg / L ~ 60 μg / L and the deviation within linear range is less than 5%. Methodologically,the good correlation between PETIA and PCT was shown. The average bias was 0. 4 μg / L and 0. 6 μg / L respectively,and the linearity bias within measuring value had no statistically significance. The PETIA had excellent anti- interference performance,within the serum samples,total containing of bilirubin（ ≤ 600 μmol / L）,hemoglobin（ ≤ 400 mg / dl）,triglyceride（ ≤ 1 000 mg/dl）,rheumatoid factor（ ≤200 IU/ml） did not affect the testing result of PCT. Conclusion PETIA on PCT has good correlation with chemiluminescence method. But the detection time is short,cost relatively low,so it has good market prospects.
出处
《中国卫生检验杂志》
北大核心
2014年第24期3559-3561,3564,共4页
Chinese Journal of Health Laboratory Technology
关键词
降钙素原
性能验证
胶乳增强免疫比浊法
化学发光法
Procalcitonin（PCT）
Performance evaluation
Particle-enhanced immunoturbimetric assay（PETIA）
Chemiluminescence method
