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储存温度波动对血清中生化分析物稳定性的影响。

The effect of storage temperature fluctuations on the stability of biochemical analytes in blood serum.

作者信息

Haslacher Helmuth, Szekeres Thomas, Gerner Marlene, Ponweiser Elisabeth, Repl Manuela, Wagner Oswald F, Perkmann Thomas

机构信息

.

出版信息

Clin Chem Lab Med. 2017 Jun 27;55(7):974-983. doi: 10.1515/cclm-2016-0608.

Abstract

BACKGROUND

Irreproducibility of scientific results constitutes an undesirably onerous economic burden and is in many cases caused by low-quality materials. Therefore, researchers are increasingly devoting their attention to the bioresources they use. In turn, those bioresources are required to validate their preanalytical processes in order to ensure best possible quality. The present study thus aimed to evaluate the impact of repeated temperature fluctuations, as they occur in most research biobanks due to repetitive opening and closing of freezer doors, on the stability of 26 biochemical analytes.

METHODS

Serum of 43 individuals was randomly assigned to a fluctuation (n=21) and a control group (n=22). Serum of the fluctuation group underwent controlled temperature fluctuations (30 fluctuations <-75°C - <-65°C - <-75°C under real-life freezer conditions within 21 days). Control sera were stored at constant conditions. After 10, 20, and 30 fluctuations, results derived from the fluctuation group were compared to baseline and to the control group by means of general linear models.

RESULTS

Sixteen biomarkers showed statistically significant changes over time, whereas only seven of those presented with diagnostically/clinically relevant changes at certain time points (aspartate aminotransferase, amylase, calcium, uric acid, creatinine, inorganic phosphate and total protein). However, there was no difference between the fluctuation and the control group.

CONCLUSIONS

Some serum analytes are influenced by storage, even at temperatures as low as <-70°C. In contrast, we found no evidence that complex temperature fluctuations produced by storage of and access to biospecimens in biobank freezers generate any additional variability.

摘要

背景

科学研究结果的不可重复性构成了令人不快的沉重经济负担,在许多情况下是由低质量材料导致的。因此,研究人员越来越关注他们所使用的生物资源。相应地,这些生物资源需要对其分析前过程进行验证,以确保尽可能高的质量。本研究旨在评估反复温度波动对26种生化分析物稳定性的影响,这种温度波动在大多数研究生物样本库中由于冷冻柜门的反复开关而出现。

方法

将43名个体的血清随机分为波动组(n = 21)和对照组(n = 22)。波动组的血清经历受控的温度波动(在21天内于实际冷冻条件下30次波动<-75°C - <-65°C - <-75°C)。对照血清在恒定条件下储存。在10次、20次和30次波动后,通过一般线性模型将波动组的结果与基线以及对照组进行比较。

结果

16种生物标志物随时间呈现出统计学上的显著变化,而其中只有7种在某些时间点呈现出诊断/临床相关变化(天冬氨酸转氨酶、淀粉酶、钙、尿酸、肌酐、无机磷酸盐和总蛋白)。然而,波动组和对照组之间没有差异。

结论

即使在低至<-70°C的温度下,一些血清分析物也会受到储存的影响。相比之下,我们没有发现证据表明生物样本库冷冻库中生物样本的储存和取用所产生的复杂温度波动会产生任何额外的变异性。

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