Department of Urology, Medical University of Vienna, Vienna, Austria.
Department of Oncology, Kaiser Franz Josef Hospital, Vienna, Austria.
Adv Ther. 2019 Apr;36(4):916-922. doi: 10.1007/s12325-019-0888-0. Epub 2019 Feb 18.
Determination of circulating prostate specific antigen (PSA) is commonly used in the diagnosis and treatment monitoring of prostate cancer [1]. Presently, PSA testing is performed in centralized laboratories, which is associated with prolonged time between venipuncture and the PSA value being available. In this prospective study, we present a new and rapid test system for the quantitative determination of PSA levels from finger-stick blood.
The Claros1 analyzer is a rapid microfluidics-based point-of-care system for quantitative PSA analysis from 10-µl finger-stick blood that requires only 10 min for testing. Total PSA concentrations by the Claros system in 100 consecutive asymptomatic men (median age 57 years, range 44-81 years) were compared with two commercially available, commonly used PSA assays (Abbott and Elecsys by Roche) performed by a reference laboratory.
Eighty-six percent of finger-stick blood-borne probes from 100 men were evaluable for PSA testing by the Claros1 analyzer system. In 13/14 cases the expiry date of the microfluid cassettes of the Claros system was exceeded and one blood puncture was performed inadequately. The correlations between the Claros results and OPKO-Abbott and OPKO-Roche assay results were high, with R values of 0.982 and 0.985, respectively. The R value for the Roche-Abbott correlation was 0.991 with a slope value of 1.160. Prostate cancer was diagnosed in seven cases, with a median PSA of 1.8 ng/ml in the Claros group compared to 1.75 ng/ml and 2.1 ng/ml in the Abbott and Roche groups, respectively.
The Claros1 PSA assay combines the advantages of rapid, accurate detection with a low required sample volume, allowing the analysis to be performed using finger-stick blood. Provided that further analysis proves the reproducibility of the test, it may help to reduce the number of office visits, thus decreasing costs to the health care system.
循环前列腺特异性抗原（PSA）的测定常用于前列腺癌的诊断和治疗监测[1]。目前，PSA 检测是在集中式实验室进行的，这与静脉穿刺和 PSA 值可用之间的时间延长有关。在这项前瞻性研究中，我们提出了一种新的快速测试系统，用于定量测定指尖采血的 PSA 水平。
Claros1 分析仪是一种快速的基于微流控的即时检测系统，可从 10µl 指尖血中定量分析 PSA，测试仅需 10 分钟。在 100 名连续无症状男性（中位年龄 57 岁，范围 44-81 岁）中，Claros 系统的总 PSA 浓度与两个商业上常用的 PSA 检测（雅培和罗氏的 Elecsys）进行了比较，这些检测是由参考实验室进行的。
在 100 名男性中，有 86%的指尖血探针可通过 Claros1 分析仪系统进行 PSA 检测。在 14 例中有 13 例超过了 Claros 系统微流盒的有效期，有 1 例采血不充分。Claros 结果与 OPKO-Abbott 和 OPKO-Roche 检测结果的相关性很高，相关系数分别为 0.982 和 0.985。罗氏-雅培的相关系数为 0.991，斜率值为 1.160。7 例诊断为前列腺癌，Claros 组 PSA 中位数为 1.8ng/ml，而 Abbott 和 Roche 组分别为 1.75ng/ml 和 2.1ng/ml。
Claros1 PSA 检测法结合了快速、准确检测的优点，同时所需样本量少，允许使用指尖血进行分析。如果进一步的分析证明了该检测的可重复性，它可能有助于减少就诊次数，从而降低医疗保健系统的成本。
