White blood cell counts (WBC) and absolute neutrophil counts (ANC) are well-established predictors of a patient9s risk of fever and infections or febrile neutropenia (FN). Currently, patients at risk of FN due to cancer chemotherapy, idiosyncratic drug-reactions or congenital neutrophil disorders are monitored at hospital or clinic laboratories. For many patients, effective and frequent monitoring is difficult due to the time required and costs of repeated laboratory visits. We herein present the first results for a novel device called Athelas One, a miniature point-of-care hematology analyzer suitable for at home monitoring of WBC and ANC. Methods: Athelas One (A1) is a small cylindrical device with a built-in, single head, light microscope. To determine the WBC and ANC, a small drop of blood (~ 3.5 uL) from a finger stick or an anticoagulated blood sample is drawn by capillary action onto a specially designed microfluidic test strip which creates a stained, precisely dimensioned monolayer of blood cells. The slide is then inserted into the device which scans the test strip and reports the WBC and ANC based on an image analysis process (Computer Vision). We compared results for A1 with a standard laboratory counter [Sysmex XE5000 (SX)]. Results: Initially, A19s reproducibility was demonstrated using 43 blood samples with a wide range of known WBCs (i.e., samples with normal counts, leukocytosis, leukopenia, neutropenia, neutrophilia) run on 4 devices using a single lot of test strips. The A1 results were then compared to SX results using the Passing Bablok Regression with Bootstrap method. These results showed strong linearity and comparability between paired anti-coagulated venous blood samples and the blood samples compared to finger prick capillary blood samples collected almost simultaneously. The slope and intercept indicated a linear relationship, with a 95% confidence for interval slope and intercept containing 1 and 0 respectively. (Comparisons: A1 blood to SX blood: WBC, r=0.998, ANC, r=0.989; A1 capillary to SX blood: WBC, r=0.998, ANC, r=0.97). Table 1 and Figure 1 show a summary of the comparisons. In addition to these results, we have tested 18 samples with WBC Summary: These initial results show that the WBC and ANC can be accurately determined with a finger stick drop of blood and this point-of-care hematology analyzer. Given its small size, ease of use and accuracy, the device is suitable for home monitoring. Disclosures Dale:Athelas, Inc.: Equity Ownership; Amgen: Consultancy, Research Funding; Sanofi-Aventi: Consultancy, Honoraria; Cellerant: Other: Scientific Advisory Board; Hospira: Consultancy; Prolong: Consultancy; Beheringer-Ingelheim: Consultancy; Coherus: Consultancy. Navarro-De La Vega:Athelas, Inc.: Employment. Parthasarathy:Athelas, Inc.: Employment, Equity Ownership. Bodapati:Athelas, Inc.: Employment, Equity Ownership, Patents & Royalties: patent owned by Athelas on the Athelas One device. Virey:Athelas, Inc.: Employment, Equity Ownership, Patents & Royalties: patent owned by Athelas on the Athelas One device. Moffatt:Athelas, Inc.: Employment, Equity Ownership, Patents & Royalties: patent owned by Athelas on the Athelas One device. Tandon:Athelas, Inc.: Employment, Equity Ownership, Patents & Royalties: patent owned by Athelas on the Athelas One device.

中文翻译：

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一种适合家庭监测白细胞和中性粒细胞计数的新型设备

白细胞计数 (WBC) 和中性粒细胞绝对计数 (ANC) 是患者发烧和感染或发热性中性粒细胞减少症 (FN) 风险的公认预测指标。目前，由于癌症化疗、特殊药物反应或先天性中性粒细胞疾病而有 FN 风险的患者在医院或临床实验室进行监测。对于许多患者而言，由于重复实验室访问所需的时间和成本，难以进行有效和频繁的监测。我们在此展示了一种名为 Athelas One 的新型设备的第一个结果，这是一种微型床旁血液分析仪，适合在家中监测 WBC 和 ANC。方法：Athelas One (A1) 是一种小型圆柱形装置，带有内置的单头光学显微镜。要确定 WBC 和 ANC，一小滴血 (~ 3. 5 uL) 从指尖或抗凝血样通过毛细管作用被抽取到专门设计的微流体测试条上，该测试条产生染色的、精确尺寸的单层血细胞。然后将载玻片插入扫描测试条并根据图像分析过程（计算机视觉）报告 WBC 和 ANC 的设备中。我们将 A1 的结果与标准实验室计数器 [Sysmex XE5000 (SX)] 进行了比较。结果：最初，使用单批试纸在 4 台设备上运行的 43 份具有广泛已知 WBC 的血液样本（即，具有正常计数、白细胞增多症、白细胞减少症、中性粒细胞减少症、中性粒细胞增多症的样本）证明了 A19s 的重现性。然后使用通过 Bootstrap 方法传递 Bablok 回归将 A1 结果与 SX 结果进行比较。这些结果表明，配对的抗凝静脉血样本和血样与几乎同时采集的指尖毛细血管血样相比具有很强的线性和可比性。斜率和截距表示线性关系，区间斜率和截距分别包含 1 和 0 的置信度为 95%。（比较：A1 血液与 SX 血液：WBC，r=0.998，ANC，r=0.989；A1 毛细血管与 SX 血液：WBC，r=0.998，ANC，r=0.97）。表 1 和图 1 显示了比较的摘要。除了这些结果之外，我们还使用 WBC 测试了 18 个样本 总结：这些初步结果表明，使用指尖滴血和这种​​即时血液分析仪可以准确测定 WBC 和 ANC。由于其体积小、易于使用和准确，该设备适用于家庭监控。披露 Dale:Athelas, Inc.：股权；安进：咨询、研究资助；Sanofi-Aventi：顾问，Honoraria；Cellerant：其他：科学顾问委员会；Hospira：咨询；延长：咨询；Beheringer-Ingelheim：咨询；Coherus：咨询。Navarro-De La Vega：Athelas, Inc.：就业。Parthasarathy：Athelas, Inc.：就业、股权。Bodapati:Athelas, Inc.：就业、股权、专利和特许权使用费：Athelas 在 Athelas One 设备上拥有的专利。Virey:Athelas, Inc.：就业、股权、专利和特许权使用费：Athelas 在 Athelas One 设备上拥有的专利。Moffatt:Athelas, Inc.：就业、股权、专利和特许权使用费：Athelas 在 Athelas One 设备上拥有的专利。Tandon：Athelas, Inc.：就业、股权、专利和特许权使用费：