Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
J Appl Lab Med. 2021 Jul 7;6(4):992-997. doi: 10.1093/jalm/jfab022.
It is important for clinical laboratories to have protocols for investigating suspected biotin interference in patient samples. VeraPrep Biotin™ is a commercial product used to rapidly deplete biotin from serum/plasma samples. The objectives of this study were to verify that VeraPrep Biotin™: (a) does not impact immunoassay analyte recovery in control samples and (b) can effectively deplete biotin from samples (both biotin-spiked and samples from donors who ingested biotin supplements).
De-identified residual waste serum/plasma samples were combined to create 9 pools for each immunoassay. Plasma/serum samples (n = 23) were obtained from 6 healthy donors at varying times following ingestion of biotin (20 mg, 100 mg, or 200 mg). Nine Elecsys immunoassays were evaluated using the e 602 (Roche Diagnostics Inc.). Control, biotin-spiked (n = 10, ∼400 ng/mL), and donor samples were assayed pre- and post-VeraPrep treatment. Percentage analyte recovery [(posttreatment/pretreatment) × 100] was calculated for control samples. A laboratory-developed LC-MS/MS method was used to quantify biotin.
In control samples (n = 81), 90-110% analyte recovery was observed post-VeraPrep treatment in over 95% of samples (77/81). The pre- and post-VeraPrep treatment biotin concentration [mean ± standard deviation (SD)] for specimens spiked with up to 500 ng/mL biotin was 357 ± 47 ng/mL and 1.0 ± 0.6 ng/mL, respectively. The mean (range) biotin concentration for the donor samples pre- and post-treatment was 166 (15-1029) ng/mL and 0.2 (<0.1-3) ng/mL, respectively (P = 0.004).
These data demonstrate that treatment with VeraPrep Biotin™ does not affect analyte recovery in biotin-negative samples and effectively depletes both spiked and endogenous biotin in serum/plasma.
临床实验室制定调查疑似生物素干扰患者样本的方案非常重要。VeraPrep Biotin™ 是一种用于快速从血清/血浆样本中去除生物素的商业产品。本研究的目的是验证 VeraPrep Biotin™：(a) 不会影响对照样本中的免疫分析物回收率，以及 (b) 能够有效去除样本中的生物素（包括生物素加标样本和摄入生物素补充剂的供体样本）。
将去识别的剩余废弃血清/血浆样本混合，为每个免疫分析创建 9 个池。从 6 名在摄入生物素后不同时间点的健康供体中获得（20mg、100mg 或 200mg）的血浆/血清样本（n=23）。使用 e602（罗氏诊断公司）评估了 9 种 Elecsys 免疫分析。在 VeraPrep 处理前后检测对照、生物素加标（n=10，约 400ng/mL）和供体样本。计算对照样本中分析物回收率 [（处理后/处理前）×100]。使用实验室开发的 LC-MS/MS 方法定量生物素。
在对照样本（n=81）中，90-110%的分析物回收率在超过 95%的样本中（77/81）在 VeraPrep 处理后观察到。添加高达 500ng/mL 生物素的标本处理前后的生物素浓度 [平均值±标准差（SD）] 分别为 357±47ng/mL 和 1.0±0.6ng/mL。处理前后供体样本的平均（范围）生物素浓度分别为 166（15-1029）ng/mL 和 0.2（<0.1-3）ng/mL（P=0.004）。
这些数据表明，VeraPrep Biotin™ 处理不会影响生物素阴性样本中的分析物回收率，并有效地去除血清/血浆中的加标和内源性生物素。
