Abstract：
OBJECTIVE: The storage of serum tumor markers (STM) at -18 °C for one year has been a legal requirement in France since 1999, but has been abolished in 2022. This raises the question of the relevance of maintaining these biobanks in terms of conditions of storage. These should only be implemented after validation; in order to maintain the integrity of the biological sample and must be controlled over time according to the laboratory\'s procedures. The aim of the study was to assess the suitability of storing 10 STMs by evaluating their stability after one year of storage at -18 °C.
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.
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.
摘要：
目的：自1999年以来，在-18°C下保存血清肿瘤标志物（STM）一年在法国一直是法律要求，但在2022年被废除。这提出了在储存条件方面维护这些生物库的相关性的问题。这些仅在验证后实施；为了保持生物样品的完整性，并且必须根据实验室的程序进行控制。该研究的目的是通过评估在-18°C下储存一年后的稳定性来评估储存10个STM的适用性。
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。
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。
