Department of Pathology, Medical College of Wisconsin, Milwaukee, WI, USA.
Applied Research and Technology, Abbott Diagnostics, Abbott Park, IL, USA.
Clin Biochem. 2021 Jul;93:26-32. doi: 10.1016/j.clinbiochem.2021.03.009. Epub 2021 Mar 24.
The objective of this study was to estimate the prevalence of biotin supplementation in United States emergency department patients using a multi-site, geographically distributed sampling model.
Biotin was measured using an Abbott ARCHITECT Biotin research use only assay in 7118 emergency department patient serum or plasma samples from five US medical centers. Samples with biotin ≥10 ng/mL underwent additional LC-MS/MS confirmatory testing for biotin and its primary metabolites. The overall and site-specific prevalence of detectable biotin was determined using the screening assay while biotin speciation (i.e., prevalence of detectable metabolites) was determined using LC-MS/MS.
Of 7118 samples screened, 291 (4.1%) had biotin ≥10 ng/mL and were considered positive. Across five medical centers, the fraction of positive samples ranged from 2.0% to 5.4%. The maximum biotin concentration observed was 355 ng/mL. Of the 285 positive screens that underwent additional LC-MS/MS testing, 89 (31%) showed detectable biotin, bisnorbiotin, and/or biotin sulfoxide. Biotin, bisnorbiotin, and biotinsulfoxide were detected in 82/89 (92.1%), 61/89 (68.5%), and 18/89 (20.2%) samples, respectively; biotin was detected in the absence of either metabolite in 18/89 (20.2%) samples.
Using a screening assay, 4.1% of emergency department patient samples were found to be potentially susceptible to interference from biotin. Confirmatory testing showed detectable biotin and/or biotin metabolites in 31% of positive screens (1.3% overall). The prevalence of biotin ≥10 ng/mL varied 2-3-fold across US emergency department patient cohorts. Biotin metabolites were observed in 80% of samples confirmed to have detectable biotin species by LC-MS/MS, suggesting that rigorous assessments of assay susceptibility to biotin interference, often performed using in vitro studies, should consider the potential role of biotin metabolites present in vivo.
本研究的目的是使用多地点、地理分布的采样模型，估计美国急诊科患者中生物素补充剂的使用情况。
在五个美国医疗中心的 7118 例急诊科患者血清或血浆样本中，使用 Abbott ARCHITECT 生物素研究专用测定法测定生物素。生物素≥10ng/ml 的样本进行 LC-MS/MS 生物素及其主要代谢物的确认性检测。使用筛选测定法确定可检测生物素的总体和特定部位的流行率，而使用 LC-MS/MS 确定生物素的特异性（即可检测代谢物的流行率）。
在 7118 例筛查样本中，有 291 例（4.1%）生物素≥10ng/ml，被认为是阳性。在五个医疗中心中，阳性样本的比例从 2.0%到 5.4%不等。观察到的最大生物素浓度为 355ng/ml。在 285 例经额外 LC-MS/MS 检测的阳性筛查中，有 89 例（31%）显示可检测到生物素、双降生物素和/或生物素亚砜。在 89 例（92.1%）、61 例（68.5%）和 18 例（20.2%）样本中分别检测到生物素、双降生物素和生物素亚砜；在 89 例（20.2%）样本中未检测到任何代谢物的情况下也检测到生物素。
使用筛选测定法，发现 4.1%的急诊科患者样本可能易受生物素干扰。确认性检测显示，在 31%的阳性筛查中可检测到生物素和/或生物素代谢物（总体为 1.3%）。在美国急诊科患者队列中，生物素≥10ng/ml 的流行率相差 2-3 倍。在通过 LC-MS/MS 确认有可检测生物素种类的样本中，观察到 80%的样本存在生物素代谢物，这表明，通常使用体外研究进行的对测定法对生物素干扰的敏感性的严格评估，应考虑到体内存在生物素代谢物的潜在作用。
