在贝克曼库尔特AU5800全自动生化分析仪上对Diazyme降钙素原（PCT）乳胶增强免疫比浊法进行分析评估。

Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800.

作者信息

Dipalo Mariella, Buonocore Ruggero, Gnocchi Cecilia, Picanza Alessandra, Aloe Rosalia, Lippi Giuseppe

出版信息

Clin Chem Lab Med. 2015 Mar;53(4):593-7. doi: 10.1515/cclm-2014-1118.

DOI:10.1515/cclm-2014-1118

PMID:25536668

Abstract

BACKGROUND

This study was aimed to evaluate the analytical performance of the novel Diazyme procalcitonin (PCT) immunoturbidimetric assay on Beckman Coulter AU5800.

METHODS

Diazyme PCT is a latex-enhanced immunoturbidimetric assay, developed for use on laboratory instrumentations with capability of reading absorbance at 600 nm. This analytical evaluation included the assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, carryover, and method comparison between Diazyme PCT and Kryptor PCT on 129 routine serum inpatient samples.

RESULTS

The LOB, LOD, and functional sensitivity of Diazyme PCT were 0.16, 0.26, and 0.28 ng/mL, respectively. The intra- and inter-assay imprecision of Diazyme PCT was between 2.9% and 7.8%. The linearity was excellent in the range of PCT values between 0.16 and 56 ng/mL, and the carryover was negligible (0.02%). A highly significant agreement was found between Kryptor PCT and Diazyme PCT in a range of concentrations between 0.16 and 111 ng/mL (Diazyme PCT=1.10×Kryptor PCT-0.89; r=0.960; p<0.001). The mean bias was 0.48 ng/mL (95% CI, -0.58 to 1.54 ng/mL). The strength of agreement between Kryptor PCT and Diazyme PCT was between 85% and 96% at 0.50, 2.0, and 10 ng/mL cutoffs.

CONCLUSIONS

Diazyme PCT appears to be a reliable assay for diagnosis and management of critical care patients susceptible to severe bacterial infections.

摘要

背景

本研究旨在评估新型Diazyme降钙素原（PCT）免疫比浊法在贝克曼库尔特AU5800上的分析性能。

方法

Diazyme PCT是一种乳胶增强免疫比浊法，专为可在600nm处读取吸光度的实验室仪器而开发。该分析评估包括空白限（LOB）、检测限（LOD）、功能灵敏度、不精密度、线性、携带污染以及在129份常规住院患者血清样本上对Diazyme PCT和Kryptor PCT进行方法比较。

结果

Diazyme PCT的LOB、LOD和功能灵敏度分别为0.16、0.26和0.28ng/mL。Diazyme PCT的批内和批间不精密度在2.9%至7.8%之间。在PCT值为0.16至56ng/mL范围内线性良好，携带污染可忽略不计（0.02%）。在浓度范围为0.16至111ng/mL时，Kryptor PCT和Diazyme PCT之间发现高度显著的一致性（Diazyme PCT = 1.10×Kryptor PCT - 0.89；r = 0.960；p < 0.001）。平均偏差为0.48ng/mL（95%CI，-0.58至1.54ng/mL）。在0.50、2.0和10ng/mL临界值时，Kryptor PCT和Diazyme PCT之间的一致性强度在85%至96%之间。