A-367 Development of a Multimodal Point-of-Care Diagnostic Platform to Perform Rapid, Accurate, and Cost-Effective Molecular, Immunochemistry, Clinical Chemistry, and Cytometry Tests

IF 7.1 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2024-10-02 DOI:10.1093/clinchem/hvae106.361

E Charrault, K Chew, A Habibi, T Ramezan, K Currier, C So, A Banaszczyk, S Bai, V Niu, K Lai, W Chang, D Caron, K Pham, O Ghosh, R Khan, B Milbes, H Swadia, J Chien, K Sathyamoorthy, P Naranatt, S Maktabi, A Singh, T Patel, F Izadi Kharazi, R Heltsley

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引用次数: 0

Abstract

Background Access to point-of-care (POC) testing can make a significant impact on the quality of care. However, because POC diagnostic platforms available today are expensive and only perform one type of test, clinicians are unable to implement all the POC tests they wish to perform. Fluxergy is developing a multimodal POC diagnostic platform that consolidates diverse diagnostic modalities into a single, compact platform to minimize the cost of POC testing and standardize testing workflow for the most common clinical chemistry, hematology, immunochemistry and molecular tests. This study describes feasibility studies performed to benchmark these assay modalities on the Fluxergy Analyzer. Methods Fluxergy Analyzer: The Fluxergy Analyzer integrates conventional detection systems—colorimetric, fluorometric, and electrochemical—into a singular POC platform. This unique design expands -omics testing capabilities, including molecular, immunochemistry, clinical chemistry, and hematology within a single instrument. Benchmarking Feasibility Studies: Molecular benchmarking was performed using a multiplex respiratory panel on contrived samples in UTM/VTM. Immunochemistry benchmarking was performed using a procalcitonin assay on spiked sodium citrate plasma samples. Cytometry benchmarking was performed using a white blood cell count (WBC) assay and testing contrived samples whole blood samples. Results For molecular testing, the Fluxergy Analyzer was able to accurately detect flu A, flu B, SARS-CoV-2, and RSV with agreements with the Luminex ARIES® Flu A/B & RSV Assay and Cepheid Xpert® SARS-CoV-2 test results. For immunochemistry testing, the Fluxergy Analyzer accurate quantified PCT levels at 0.3, 0.6, 1.25 and 2.5 ng/mL. For hematology testing, the Fluxergy Analyzer demonstrated a strong correlation across the reportable range against the standard of care HemoCue analyzer. For clinical chemistry testing, the Fluxergy Analyzer demonstrated a strong correlation against the Siemen’s epoc® Blood Analysis System. Conclusions The Fluxergy Analyzer is uniquely suited to offer a comprehensive menu of the most common POC tests on a single, cost-effective platform.

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A-367 开发多模式床旁诊断平台，以进行快速、准确和经济高效的分子、免疫化学、临床化学和细胞计量测试

背景获取床旁检测（POC）可对医疗质量产生重大影响。然而，由于目前市面上的 POC 诊断平台价格昂贵，而且只能进行一种类型的检测，临床医生无法实施他们希望进行的所有 POC 检测。Fluxergy 公司正在开发一种多模态 POC 诊断平台，它将各种诊断模式整合到一个单一、紧凑的平台中，以最大限度地降低 POC 检验的成本，并使最常见的临床化学、血液学、免疫化学和分子检验的检验工作流程标准化。本研究介绍了在 Fluxergy 分析仪上对这些检测模式进行基准测试的可行性研究。方法 Fluxergy 分析仪：Fluxergy 分析仪将传统的检测系统--比色法、荧光法和电化学法整合到一个单一的 POC 平台中。这种独特的设计扩展了组学检测功能，包括在一台仪器中进行分子、免疫化学、临床化学和血液学检测。基准可行性研究：在UTM/VTM中使用多重呼吸面板对假定样本进行分子基准测试。使用加标柠檬酸钠血浆样本的降钙素原检测法进行了免疫化学基准测试。使用白细胞计数（WBC）测定法和全血样本测试模拟样本进行了细胞测定基准测试。结果在分子检测方面，Fluxergy 分析仪能够准确检测甲型流感、乙型流感、SARS-CoV-2 和 RSV，与 Luminex ARIES® Flu A/B & RSV Assay 和 Cepheid Xpert® SARS-CoV-2 检测结果一致。在免疫化学检测方面，Fluxergy 分析仪能准确量化 0.3、0.6、1.25 和 2.5 纳克/毫升的 PCT 水平。在血液学检测方面，Fluxergy 分析仪在可报告范围内与标准医疗设备 HemoCue 分析仪具有很强的相关性。在临床化学检验方面，Fluxergy 分析仪与西门的 epoc® 血液分析系统有很强的相关性。结论 Fluxergy 分析仪具有独特的优势，可以在一个单一、经济高效的平台上提供最常见的 POC 检验的综合菜单。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.