Use of CTX-I and PINP as bone turnover markers: National Bone Health Alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability
Use of CTX-I and PINP as bone turnover markers: National Bone Health Alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability
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DOI：
10.1007/s00198-017-4082-4
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发表时间：
2017-09-01
影响因子：
4
通讯作者：
Leary, E. T.
中科院分区：
文献类型：
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作者：
Szulc, P.;Naylor, K.;Leary, E. T.
IOF和国际临床化学联合会(IFCC)骨标记物标准工作组已确定血液中的PINP和CTX-I可作为骨转换的参考标记物，用于骨折风险预测和骨质疏松治疗监测。尽管骨转换标记物(BTM)已用于临床研究多年，但由于其在受试者内和实验室间的重复性较差，尚未被广泛应用于临床实践。NBHA骨周转标志物项目团队旨在通过标准化的样品处理和患者准备来降低CTX-I和PINP测量的分析前变异性。基于对现有出版物的回顾和务实考虑，提出了关于样品处理和患者准备的建议，以减少分析前变异性。为了便于解释和样本采集，对可控和不可控的患者相关因素进行了综述。CTX-I的样本必须在禁食状态下的早晨持续采集。EDTA等离子体是CTX-I的首选，因为它具有更好的样品稳定性。PINP的样本采集条件不那么关键，因为PINP具有最小的昼夜变化，不受食物摄入量的影响。应遵守样品稳定性限值。在BTM的解释中应考虑不可控因素(年龄、性别、怀孕、不能动、最近骨折、合并症、抗骨质疏松药物、其他药物)。采用标准化的样品处理和患者准备程序将显著减少可控的分析前变异性。要成功采纳这些建议，就必须在全球舞台上与各利益攸关方密切合作，包括实验室、医学界、试剂制造商和监管机构。
The IOF and the International Federation of Clinical Chemistry (IFCC) Bone Marker Standards Working Group have identified PINP and CTX-I in blood to be the reference markers of bone turnover for the fracture risk prediction and monitoring of osteoporosis treatment. Although used in clinical research for many years, bone turnover markers (BTM) have not been widely adopted in clinical practice primarily due to their poor within-subject and between-lab reproducibility. The NBHA Bone Turnover Marker Project team aim to reduce pre-analytical variability of CTX-I and PINP measurements through standardized sample handling and patient preparation.Recommendations for sample handling and patient preparations were made based on review of available publications and pragmatic considerations to reduce pre-analytical variability. Controllable and un-controllable patient-related factors were reviewed to facilitate interpretation and sample collection.Samples for CTX-I must be collected consistently in the morning hours in the fasted state. EDTA plasma is preferred for CTX-I for its greater sample stability. Sample collection conditions for PINP are less critical as PINP has minimal circadian variability and is not affected by food intake. Sample stability limits should be observed. The uncontrollable aspects (age, sex, pregnancy, immobility, recent fracture, co-morbidities, anti-osteoporotic drugs, other medications) should be considered in BTM interpretation.Adopting standardized sample handling and patient preparation procedures will significantly reduce controllable pre-analytical variability. The successful adoption of such recommendations necessitates the close collaboration of various stakeholders at the global stage, including the laboratories, the medical community, the reagent manufacturers and the regulatory agencies.