自动KRYPTOR嗜铬粒蛋白A检测法与DAKO酶联免疫吸附测定法的比较。
Comparison of the automated KRYPTOR chromogranin A assay with the DAKO ELISA.
作者信息
Wolf Magnus, Riedlinger Isolde, Lehmann Rainer, Häring Hans-Ulrich, Schleicher Erwin, Peter Andreas
出版信息
Clin Lab. 2014;60(12):2103-6. doi: 10.7754/clin.lab.2014.140422.
BACKGROUND
Currently available assays for the widely used marker for neuroendocrine tumors chromogranin A have a weak comparability, involve manual work, and require batch processing of the samples. In this study, we evaluated the automated chromogranin A KRYPTOR assay compared with the widely used DAKO ELISA.
METHODS
83 samples were measured with the DAKO ELISA (EDTA plasma) and the KRYPTOR assay (serum), since different sample materials are recommended. Furthermore, different sample materials were compared.
RESULTS
The results between the two assays were highly correlated (KRYPTOR serum (ng/mL) = 2.887 ELISA EDTA (U/L) + 5.028; r = 0.99). The inter-assay variation for the KRYPTOR assay was determined as 5.56% at low (95 ng/mL; n = 34) and 6.21% at high (530 ng/mL; n = 33) chromogranin A concentrations. EDTA plasma samples revealed significantly lower results than serum in the KRYPTOR assays and could not be used.
CONCLUSIONS
In conclusion, the new chromogranin A KRYPTOR assay is fast, reliable, and compares well to an established test after adaptation of sample material and reported units.
背景
目前用于神经内分泌肿瘤广泛使用的标志物嗜铬粒蛋白A的检测方法可比性差，涉及手工操作，且需要对样本进行批量处理。在本研究中，我们评估了自动化的嗜铬粒蛋白A KRYPTOR检测方法，并与广泛使用的DAKO酶联免疫吸附测定法进行比较。
方法
由于推荐使用不同的样本材料，因此用DAKO酶联免疫吸附测定法（乙二胺四乙酸血浆）和KRYPTOR检测法（血清）对83份样本进行检测。此外，还对不同的样本材料进行了比较。
结果
两种检测方法的结果高度相关（KRYPTOR血清（纳克/毫升）=2.887×酶联免疫吸附测定法乙二胺四乙酸（单位/升）+5.028；r=0.99）。在嗜铬粒蛋白A浓度低（95纳克/毫升；n=34）时，KRYPTOR检测法的批间变异系数为5.56%，在浓度高（530纳克/毫升；n=33）时为6.21%。在KRYPTOR检测法中，乙二胺四乙酸血浆样本的结果显著低于血清样本，因此不能使用。
结论
总之，新的嗜铬粒蛋白A KRYPTOR检测方法快速、可靠，在调整样本材料和报告单位后，与既定检测方法相比效果良好。
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