Evidence for stability of cardiac troponin T concentrations measured with a high sensitivity TnT test in serum and lithium heparin plasma after six-year storage at -80 °C and multiple freeze-thaw cycles.

IF 3.8 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2024-10-31 DOI:10.1515/cclm-2024-0787

Linda M Henricks, Fred P H T M Romijn, Christa M Cobbaert

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Abstract

Objectives: As high-sensitivity cardiac troponin T (hs-cTnT) is making the transition from diagnostic to prognostic use, a long-term stability study of 5th generation hs-cTnT according to EFLM CRESS recommendations was set up for investigation of frozen clinical specimens (two matrices).

Methods: Study samples collected in serum tubes and lithium heparin tubes with gel from patients admitted for suspected minor myocardial damage were measured directly after completion of the study (0 years), and after 3-year and 6-year storage at -80 °C, and recovery of hs-cTnT concentrations after long-term storage (%hs-cTnT concentration compared to 0-year) was calculated. Hs-cTnT changes were also compared to decisive delta changes, such as the ones proposed in the ESC NSTEMI 0 h/1 h algorithm (<3 or >5 ng/L for ruling out and ruling in suspected NSTEMI patients).

Results: Eighty-six patients were included in the study, whereof 28 both lithium heparin plasma and serum samples were collected simultaneously, in others only serum (n=30) or plasma (n=28). Multiple aliquots per patient were made, so that 479 serum and 473 plasma samples were available for analysis. Across the overall hs-cTnT measuring range, median recovery after 6 years was 105.4 % and 106.2 % for serum and plasma, respectively. Based on these decisive delta changes, serum showed consistent results upon long term storage (max 0.8 % of samples above delta threshold of >5 ng/L) as compared to heparin plasma (up to 19.2 % of samples above threshold).

Conclusions: Over 6 years of storage at -80 °C, recovery of hs-cTnT in serum and heparin plasma was similar and within common lot-to-lot variation. Yet, when evaluating absolute delta increments around hs-cTnT clinical decision points, long-term stored sera displayed better clinical performance compared to heparin plasma samples.

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用高灵敏度 TnT 测试法测量血清和锂肝素血浆中的心肌肌钙蛋白 T 浓度，在零下 80 摄氏度和多次冻融循环下保存六年后，其稳定性得到证明。

研究目的由于高敏心肌肌钙蛋白 T（hs-cTnT）正从诊断用途向预后用途过渡，因此根据 EFLM CRESS 的建议，对冷冻临床样本（两种基质）进行了第五代 hs-cTnT 长期稳定性研究：方法：从疑似轻微心肌损伤入院患者的血清管和肝素锂凝胶管中采集研究样本，在研究结束后（0 年）、在 -80 °C 下保存 3 年和 6 年后直接进行测量，并计算长期保存后 hs-cTnT 浓度的恢复情况（与 0 年相比的 hs-cTnT 浓度百分比）。hs-cTnT的变化还与决定性的δ变化进行了比较，如ESC NSTEMI 0小时/1小时算法中提出的δ变化（5纳克/升用于排除和排除疑似NSTEMI患者）：研究共纳入 86 例患者，其中 28 例患者同时采集了肝素锂血浆和血清样本，其他患者仅采集了血清（30 例）或血浆（28 例）。每位患者都采集了多个等分样本，因此有 479 份血清和 473 份血浆样本可供分析。在整个 hs-cTnT 测量范围内，6 年后血清和血浆的中位恢复率分别为 105.4% 和 106.2%。根据这些决定性的δ变化，与肝素血浆（最多有 19.2% 的样本超过阈值）相比，血清在长期储存后显示出一致的结果（最多有 0.8% 的样本超过大于 5 纳克/升的δ阈值）：在-80 °C下保存6年后，血清和肝素血浆中hs-cTnT的回收率相似，且批次间差异不大。然而，在评估 hs-cTnT 临床决策点附近的绝对三角增量时，长期储存的血清比肝素血浆样本显示出更好的临床表现。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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!

Evidence for stability of cardiac troponin T concentrations measured with a high sensitivity TnT test in serum and lithium heparin plasma after six-year storage at -80 °C and multiple freeze-thaw cycles.

Abstract

Evidence for stability of cardiac troponin T concentrations measured with a high sensitivity TnT test in serum and lithium heparin plasma after six-year storage at -80 °C and multiple freeze-thaw cycles.