D-dimer testing combined with a clinical assessment has become a standard pathway for ruling-out venous thromboembolism (VTE). Recently, novel Point-of-Care (POC) D-dimer assays have been introduced, enabling low-volume blood sampling for rapid exclusion of VTE in a one-step procedure. We assessed the analytical validity and user-friendliness of a set of these novel POC D-dimer assays, and compared the results with a standard laboratory assay. Plasma samples were run on our reference assay (STA-Liatest D-di PLUS^®) and five POC assays: Nano-Checker 710^®, AFIAS-1^®; iChroma-II^®; Standard F200^® and Hipro AFS/1^®). After evaluating imprecision, Pearson Product-Moment correlation coefficients were calculated, Passing Bablok regression was performed and Bland-Altman plots were generated. User-friendliness was evaluated using the System Usability Scale (SUS). A set of 238 plasma samples of patients clinically suspected of VTE in general practice was available for analysis. Only one POC D-dimer assay (Nano-Checker 710) demonstrated an insufficient degree of imprecision. Pearson correlation coefficients and mean biases ranged from 0.68 to 0.93 and −165 to −53 μg/L respectively, and concordance with our reference assay varied from 71.8% to 89.5% using a 500 μg/L cut-off point. While we found considerable variation in overall user-friendliness, most devices were judged easy to use. In view of our findings regarding analytical performance and user-friendliness, we consider most of the novel POC D-dimer assays can be used in settings outside of the laboratory such as general practice, combining the possibility of multi-testing with low-volume capillary blood sampling and processing times of less than 15 min.

D-二聚体检测与临床评估相结合已成为排除静脉血栓栓塞（VTE）的标准途径。最近，已经推出了新颖的即时护理（POC）D-二聚体测定法，可通过一步操作进行小剂量血液采样，以快速排除VTE。我们评估了这些新型POC D-二聚体测定法的分析有效性和用户友好性，并将结果与​​标准实验室测定法进行了比较。血浆样品在我们的参考测定中运行（STA-Liatest d二叔PLUS ^®）和五个POC分析：纳米检查器710 ^®，AFIAS-1 ^® ; iChroma-II ^® ; 标准F200 ^®和翰普AFS / 1 ^®）。在评估不精确度之后，计算出Pearson乘积矩相关系数，进行Passing Bablok回归并生成Bland-Altman图。使用系统可用性量表（SUS）评估了用户友好性。一般情况下，一组238例临床上通常怀疑为VTE的患者血浆样本可用于分析。仅一种POC D-二聚体测定法（Nano-Checker 710）显示不充分的不精确度。皮尔逊相关系数和平均偏差分别在0.68至0.93和-165至-53μg/ L范围内，并且使用500μg/ L的临界点，与我们的参考测定的一致性在71.8％至89.5％之间。尽管我们发现总体上用户友好性存在很大差异，但大多数设备仍被认为易于使用。鉴于我们对分析性能和用户友好性的发现，