Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma

Qualification of M30 and M65 ELISAs as surrogate biomarkers of cell death: long term antigen stability in cancer patient plasma
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DOI:
10.1007/s00280-007-0437-4
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发表时间:
2007-11-01
影响因子:
3
通讯作者:
Dive, C.
Dive, C.
中科院分区:
医学3区
文献类型:
--
作者:
Cummings, J.;Ranson, M.;Dive, C.

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目的M30和M65 ELISA被认为是患者肿瘤细胞死亡的替代生物标志物,并越来越多地应用于临床试验期间抗癌药物的药效学(PD)评价。在缺乏这些数据的情况下,我们研究了在-80℃保存2年多的癌症患者血浆中两种检测方法的抗原的长期稳定性。结果没有检测到M65抗原降解的证据。然而,在一部分患者中检测到M30抗原水平的显著升高。结论用于M65分析的血浆样本可以在-80℃保存2年;但是,当考虑长期保存M30分析的样本时,建议谨慎。
Purpose M30 and M65 ELISAs are proposed as surrogate biomarkers of tumour cell death in patients and are being applied increasingly in the pharmacodynamic (PD) evaluation of anticancer drugs during clinical trials. In the absence of such data, we have studied the long-term stability of the antigens of both assays in plasma of cancer patients stored at -80 degrees C over 2 years.Results No evidence was detected of degradation in the M65 antigen. However, in a proportion of patients significant increases in levels of M30 antigen were detectedConclusion Plasma samples for M65 analysis can be stored at -80 degrees C for 2 years; however, caution is recommended when considering long-term storage of samples for the M30 assay.