Methodology evaluation and Clinical significance of Procalcitonin test using Latex enhanced immunoturbidimetric assay
10.3969/j.issn.1673-4130.2014.24.043
- VernacularTitle:胶乳增强免疫比浊法测定降钙素原方法学评价及临床意义
- Author:
Liang FANG
- Publication Type:Journal Article
- Keywords:
Procalcitonin;
Latex enhanced Immunoturbidimetric assay;
Sepsis
- From:
International Journal of Laboratory Medicine
2014;(24):3401-3403
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the performance characteristic of Procalcitonin (PCT)Latex-enhanced immunoturbidimetric assay(LETIA)kit and explore its clinical application on diagnosis of sepsis.Methods The precision,recovery rate,linearity,anti-interference,correlation and clinical application of PCT kit were analyzed in this study according to standards developed by Clinical and laboratory standards institute (CLSI).Results The within-run and day-to-day run imprecision (CVs)of kit was <5.0% and<2.0% respectively at two medical diagnosis level (0.5 and 2.0μg/L).The average recovery rate was 100.6%.Linear range was from 0.05-60 μg/L,R2=0.996 as basis of determination.The test deviation was<10%,the result was obtained after repeated test of reagent kept with lid open for one month and lid closed in 37 ℃ water bath for 8 days.The test results of PCT kit using LE-TIA method were highly correlated with Roche PCT Chemiluminescence immunoassay (CLIA)kit.The PCT LETIA kit has excel-lent anti-interference performance,the serum samples containing Total Bilirubin ≤600 μmol/L,Hemoglobin ≤400 mg/dL,Triglyc-eride ≤1 000 mg/dL,Rheumatoid factor ≤200 IU/mL did not affect the testing result of the kit.The average levels of PCT in the experimental (Sepsis)group was (14.783μg/L±5.654μg/L),which in the control group was (0.237 μg/L±0.107 μg/L),there was statistically significant difference between them (P <0.05).Conclusion The PCT test using LETIA is a rapid、precise and re-liable method and it can be used for clinical diagnosis of sepsis.
