Stability of 54 biochemical analytes in capped serum samples stored at 4-8 °C: a 72-h longitudinal evaluation.

IF 4.4 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Paula Tauler-Quetglas, María Sanz-Felisi, Sofía Durán-Espín, Teresa Escartín-Díez, Alicia Madurga, Ariadna Arbiol-Roca
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引用次数: 0

Abstract

Objectives: To evaluate the stability of 54 biochemical analytes in blood samples that were centrifuged, capped, and stored at 4-8 °C for 24, 48, and 72 h.

Methods: A prospective study was conducted with 588 serum samples using the Cobas® 8000 modular analyzer and the Cobas® p701 post-analytical unit (Roche Diagnostics). Analytes were measured at baseline and after 24, 48, and 72 h. Stability limits were determined by comparing percentage deviations against the maximum permissible instability criteria established.

Results: The majority of the evaluated analytes showed acceptable analytical stability for up to 72 h. However, seven analytes remained stable for only up to 48 h (albumin, alkaline phosphatase, calcium, free prostatic specific-antigen, gamma-glutamyl transferase, potassium and total protein). Ten analytes showed reduced stability, remaining reliable for only 24 h (chloride, folate, parathyroid hormone, triglycerides and vitamin B12) or less (alanine aminotransferase, alpha-amylase, inorganic phosphate, troponin and uric acid).

Conclusions: Refrigerated storage at 4-8 °C ensures the analytical stability of 38 out of 54 biochemical analytes for up to 72 h, validation that safely covers typical weekend operational delays and requests for add-on testing. Nonetheless, specific time restrictions must be strictly enforced for the unstable analytes identified to guarantee clinical accuracy.

在4-8 °C保存的盖帽血清样品中54种生化分析物的稳定性:72小时纵向评价。
目的:评价54种生化分析物在4-8 °C离心、盖帽、保存24、48和72 h的血液样品中的稳定性。方法:采用Cobas®8000模块化分析仪和Cobas®p701后分析单元(罗氏诊断公司)对588份血清样本进行前瞻性研究。在基线和24、48和72 h后测量分析物。稳定性极限是通过比较与最大允许不稳定性标准的偏差百分比来确定的。结果:大多数评价的分析物在72 h内具有可接受的分析稳定性。然而,七种分析物仅在48 h内保持稳定(白蛋白、碱性磷酸酶、钙、游离前列腺特异性抗原、γ -谷氨酰转移酶、钾和总蛋白)。10种分析物的稳定性降低,仅对24 h(氯化物、叶酸、甲状旁腺激素、甘油三酯和维生素B12)或更少(丙氨酸转氨酶、α -淀粉酶、无机磷酸盐、肌钙蛋白和尿酸)保持可靠。结论:4-8 °C冷藏可确保54种生化分析物中38种的分析稳定性长达72 h,验证可安全地覆盖典型的周末操作延迟和附加测试请求。尽管如此,必须严格执行不稳定分析物鉴定的具体时间限制,以保证临床准确性。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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