METHODS: A new immuno-enzymatic assay (A+1) was conducted on samples that had been stored at -18 °C for one year after an initial assay (A) of one of the following STMs: carcino-embryonic antigen (CEA), alpha-fetoprotein (AFP), carbohydrate antigen 125 (CA125), carbohydrate antigen 15-3 (CA15-3), carbohydrate antigen 19-9 (CA19-9), total (TPSA), and free (FPSA) prostate-specific antigen, calcitonin (CT), thyroglobulin (TG), and neuro-specific enolase (NSE). The results were confronted to four different permissible error sources.
RESULTS: In total, 1148 A+1 assays were performed. A strong correlation between A+1 and A values was found for all analytes, but with a statistically significant reduction in the mean A+1 concentration compared to the mean A concentration in 7/10 STMs. The bias induced by conservation seems to be technically unsustainable if we rely on the repositories closest to the current analytical performances.
CONCLUSIONS: These results support the discontinuation of mandatory STM biobank storage at -18 °C, which requires considerable technical time and organizational effort.
方法:对以下STM之一的初始测定(A)后在-18°C下储存了一年的样品进行了新的免疫酶测定(A1):癌胚抗原(CEA),甲胎蛋白(AFP),糖类抗原125(CA125),糖类抗原15-3(CA15-3),糖类抗原19-9(CA19-9),总计(TPSA),和游离(FPSA)前列腺特异性抗原,降钙素(CT),甲状腺球蛋白(TG),和神经特异性烯醇化酶(NSE)。结果面临四个不同的允许误差源。
结果:总计,进行1148个A+1测定。对于所有分析物,A+1和A值之间都有很强的相关性,ButwithastatisticallysignificantreductioninthemeanA+1concentrationcomparedtothemeanAconcentrationin7/10STMs.Thebiasinducedbyconservationseentobetechnicallyunaboveifwerelayontherepostersclosesttothecurrentanalyt
结论:这些结果支持停止在-18°C下强制储存STM生物库,这需要相当多的技术时间和组织努力。