一种新开发的采用化学发光法的肿瘤标志物CA15-3定量测定试剂盒的评估

Evaluation of a newly developed quantitative determination kit for tumor marker CA15-3 with chemiluminescent assay.

作者信息

Li Peihua, Ye Huiming, Liu Jiangwu, Jin Hongwei, Lin Yongzhi, Yan Shuidi, Yu Yang, Gao Lei, Xu Feihai, Zhang Zhongying

机构信息

Center for Clinical Laboratory, Xiamen University Affiliated Zhongshan Hospital, Xiamen, China.

Department of Clinical laboratory, Xiamen's Maternal and Child Health Hospital, Xiamen, China.

出版信息

J Clin Lab Anal. 2018 Jan;32(1). doi: 10.1002/jcla.22158. Epub 2017 Feb 23.

DOI:10.1002/jcla.22158

PMID:28233344

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5811926/

Abstract

BACKGROUND

Tumor marker carbohydrate antigen 15-3 (CA15-3) is used as a biomarker to aid to diagnose and monitor the prognosis of breast cancer patients. A new quantitative determination kit for CA15-3 with chemiluminescent assay was developed by Xiamen InnoDx Biotech Co., Ltd, China. Therefore, we conducted the report to evaluate the performance of the kit.

METHODS

According to the "Guiding principles on performance analysis of diagnostic reagents in vitro", the calibration curve, limit of detection, reportable range, accuracy, precision, anti-interference capability, cross-reaction and comparison by measuring EDTA plasma and serum were carried out. In addition, the kit was performed in parallel to electrochemiluminescence immunoassay kit (Roche) to analyze the correlation between the two kits.

RESULTS

Regression equation of calibration curve of the kit was Y=0.7914X+4.1032 (R =.990). Limit of detection was 0.0347 U/mL. The reportable range was 0.5-2400 U/mL. Recovery ratio was 100.0%-104.8%. Coefficient of variations (CVs) of within-run and between-run were 4.8%-7.6% and 5.8%-7.4% respectively. No remarkable interferences (all Bias% were less than ±10%) were detected when samples contained hemoglobin ≤183.8 μmol/L, bilirubin ≤340 μmol/L, triglyceride ≤18.1 mmol/L, or rheumatoid factor ≤400 U/mL. No cross-reaction was present in the kit. Moreover, compared with the results from electrochemiluminescence immunoassay kit (Roche) in 345 serum samples, there was a satisfied correlation coefficient of 0.977 (P<.01), and the kit was simultaneously fit for the detection of EDTA plasma and serum samples.

CONCLUSION

The new kit validated satisfactorily, and it can be used for detecting CA15-3 in clinical practice.

摘要

背景

肿瘤标志物糖类抗原15-3（CA15-3）用作辅助诊断和监测乳腺癌患者预后的生物标志物。中国厦门英诺德生物科技有限公司研发了一种采用化学发光法的新型CA15-3定量检测试剂盒。因此，我们开展本报告以评估该试剂盒的性能。

方法

按照《体外诊断试剂性能分析指导原则》，进行校准曲线、检测限、报告范围、准确度、精密度、抗干扰能力、交叉反应以及通过检测乙二胺四乙酸（EDTA）血浆和血清进行比较。此外，该试剂盒与电化学发光免疫分析试剂盒（罗氏公司）进行平行检测，以分析两种试剂盒之间的相关性。

结果

该试剂盒校准曲线的回归方程为Y = 0.7914X + 4.1032（R = 0.990）。检测限为0.0347 U/mL。报告范围为0.5 - 2400 U/mL。回收率为100.0% - 104.8%。批内和批间变异系数（CV）分别为4.8% - 7.6%和5.8% - 7.4%。当样本中血红蛋白≤183.8 μmol/L、胆红素≤340 μmol/L、甘油三酯≤18.1 mmol/L或类风湿因子≤400 U/mL时，未检测到明显干扰（所有偏差百分比均小于±10%）。该试剂盒不存在交叉反应。此外，与345份血清样本的电化学发光免疫分析试剂盒（罗氏公司）结果相比，相关系数为0.977，令人满意（P < 0.01），且该试剂盒同时适用于检测EDTA血浆和血清样本。