Nishikawa Yukihiro, Nishida Shiyo, Kuroda Keiko, Kashiwagi Hirokazu, Tomiyama Yoshiaki, Kuwana Masataka
Medical & Biological Laboratories Co., Ltd., Nagoya 460-0008, Japan.
Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka 565-0871, Japan.
Diagnostics (Basel). 2022 Jan 26;12(2):313. doi: 10.3390/diagnostics12020313.
Plasma thrombopoietin (TPO) measurements help distinguish between different types of thrombocytopenia but are not feasible in routine clinical practice. We developed a fully automated quantitative chemiluminescent enzyme immunoassay (CLEIA) for measuring TPO (TPO-CLEIA), which is a one-step sandwich-type assay. This assay utilizes a mouse monoclonal capture antibody, which has the neutralizing epitope of the interaction between TPO and the TPO receptor, and a newly generated rabbit monoclonal detector antibody. In analytical performance studies, this assay showed good linearity over the measuring range and high sensitivity. The limit of quantification (LoQ) of this assay was 3.4 pg/mL; low TPO concentration values of almost all healthy individuals exceeded the LoQ value. In clinical validation studies, TPO levels obtained from patients with aplastic anemia (AA) significantly increased, whereas those of patients with immune thrombocytopenia (ITP) were normal or slightly increased. The cutoff value for TPO-CLEIA corresponding to the previously reported values was useful for distinguishing between ITP and AA. These results suggest that TPO-CLEIA can quantify human plasma TPO levels with high accuracy and sensitivity and has the potential to facilitate routine clinical measurement of TPO in patients with various types of thrombocytopenia.
血浆血小板生成素（TPO）检测有助于区分不同类型的血小板减少症，但在常规临床实践中并不可行。我们开发了一种用于测量TPO的全自动定量化学发光酶免疫分析方法（TPO-CLEIA），这是一种一步夹心型分析方法。该分析方法使用一种具有TPO与TPO受体相互作用中和表位的小鼠单克隆捕获抗体，以及一种新产生的兔单克隆检测抗体。在分析性能研究中，该分析方法在测量范围内显示出良好的线性和高灵敏度。该分析方法的定量下限（LoQ）为3.4 pg/mL；几乎所有健康个体的低TPO浓度值均超过LoQ值。在临床验证研究中，再生障碍性贫血（AA）患者的TPO水平显著升高，而免疫性血小板减少症（ITP）患者的TPO水平正常或略有升高。与先前报道的值相对应的TPO-CLEIA临界值有助于区分ITP和AA。这些结果表明，TPO-CLEIA能够高精度、高灵敏度地定量检测人血浆TPO水平，并且有潜力促进对各种类型血小板减少症患者进行TPO的常规临床检测。
