Clin Chem Lab Med. 2017 Mar 1;55(3):424-434. doi: 10.1515/cclm-2016-0194.
Serum free light chains (FLC) are sensitive biomarkers used for the diagnosis and management of plasma cell dyscrasias, such as multiple myeloma (MM), and are central to clinical screening algorithms and therapy response criteria. We have developed a portable, near-patient, lateral-flow test (Seralite®) that quantitates serum FLC in 10 min, and is designed to eliminate sample processing delays and accelerate decision-making in the clinic.
Assay interference, imprecision, lot-to-lot variability, linearity, and the utility of a competitive-inhibition design for the elimination of antigen-excess ('hook effect') were assessed. Reference ranges were calculated from 91 healthy donor sera. Preliminary clinical validation was conducted by retrospective analysis of sera from 329 patients. Quantitative and diagnostic results were compared to Freelite®.
Seralite® gave a broad competitive-inhibition calibration curve from below 2.5 mg/L to above 200 mg/L, provided good assay linearity (between 1.6 and 208.7 mg/L for κ FLC and between 3.5 and 249.7 mg/L for λ FLC) and sensitivity (1.4 mg/L for κ FLC and 1.7 mg/L for λ FLC), and eliminated anomalous results from antigen-excess. Seralite® gave good diagnostic concordance with Freelite® (Roche Hitachi Cobas C501) identifying an abnormal FLC ratio and FLC difference in 209 patients with newly diagnosed MM and differentiating these patients from normal healthy donors with polyclonal FLC.
Seralite® sensitively quantitates FLC and rapidly identifies clinical conditions where FLC are abnormal, including MM.
血清游离轻链（FLC）是用于诊断和管理浆细胞异常的敏感生物标志物，如多发性骨髓瘤（MM），并是临床筛选算法和治疗反应标准的核心。我们开发了一种便携式、床边、侧向流动测试（Seralite®），可在 10 分钟内定量血清 FLC，旨在消除样品处理延迟并加速临床决策。
评估了测定干扰、不精密度、批间变异性、线性以及用于消除抗原过剩的竞争抑制设计的效用（“钩状效应”）。参考范围是从 91 份健康供体血清计算得出的。通过对 329 例患者血清的回顾性分析进行了初步临床验证。将定量和诊断结果与 Freelite®进行了比较。
Seralite®提供了一个从 2.5mg/L 以下到 200mg/L 以上的宽竞争抑制校准曲线，提供了良好的测定线性（κ FLC 在 1.6 到 208.7mg/L 之间，λ FLC 在 3.5 到 249.7mg/L 之间）和灵敏度（κ FLC 为 1.4mg/L，λ FLC 为 1.7mg/L），并消除了抗原过剩引起的异常结果。Seralite®与 Freelite®（罗氏日立 Cobas C501）具有良好的诊断一致性，可识别 209 例新诊断的 MM 患者中异常的 FLC 比值和 FLC 差异，并将这些患者与具有多克隆 FLC 的正常健康供体区分开来。
Seralite®灵敏地定量 FLC，并快速识别 FLC 异常的临床情况，包括 MM。
