A-368 Feasibility of a Five-Minute Sample-to-Answer Basic Metabolic Panel for Point-of-Care Testing on the Fluxergy Analyzer

IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry Pub Date : 2024-10-02 DOI:10.1093/clinchem/hvae106.362
E Charrault, X Zhen, E Dumitrescu, P Prakash, E Pineda, D Caron, B Hernandez, P Lamberg, K Sathyamoorthy, S Gandhi, A Singh, T Patel, R Heltsley
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Abstract

Background Adoption of point-of-care (POC) platforms has been limited by their high cost and limited menu (e.g., molecular only). Fluxergy has developed a cost-effective multimodal POC platform capable of performing the most common clinical chemistry, immunochemistry, hematology, molecular tests in CLIA-waived settings. This method comparison study describes the performance of the Fluxergy’s feasibility stage basic metabolic panel (BMP) with contrived samples compared to the Siemen’s epoc® Blood Analysis System. Methods Fluxergy Analyzer: The Fluxergy Analyzer is a rapid and cost-effective multimodality platform that can perform lab-quality PCR, clinical chemistry, immunochemistry, and cytometry in a single instrument and if required, in a single cartridge. Fluxergy BMP: Fluxergy BMP rapidly quantifies key electrolytes (K+, Na+, Ca2+, Cl-) and metabolites (glucose, creatinine, and BUN) from whole blood in under five minutes on the Fluxergy Analyzer, utilizing the Fluxergy test cards with screen-printed electrochemical sensor. Feasibility Study: A method comparison study was conducted to assess the performance of the feasibility stage Fluxergy BMP using contrived samples generated by spiking known concentrations of K+, Na+, Ca2+, Cl-, and glucose into buffer solutions. Samples were tested in triplicate with both the Fluxergy BMP and Siemen’s epoc® Blood Analysis System at three different concentrations across the reportable range of the epoc® Blood Analysis System. Results The feasibility stage Fluxergy BMP demonstrated strong correlation across the reportable range for K+, Na+, Ca2+, Cl-, and glucose versus the epoc® Blood Analysis System (Table 1). The error percentage for all samples tested except one glucose sample (9.5 mM) was less than 10%. The coefficient of variance for all samples tested except one Ca2+ sample (0.44 mM) was less than ten percent. Conclusions This feasibility data demonstrates the Fluxergy Analyzer is well-suited to perform rapid and accurate metabolic testing from whole blood samples at the POC.
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A-368 在通量能分析仪上进行 5 分钟从样本到答案的基本代谢面板床旁检测的可行性研究
背景 护理点(POC)平台的采用一直受到高成本和有限菜单(如仅分子检测)的限制。Fluxergy 公司开发了一种高性价比的多模态 POC 平台,能够在 CLIA 豁免的环境下进行最常见的临床化学、免疫化学、血液学和分子检验。本方法比较研究描述了 Fluxergy 的可行性阶段基本代谢面板 (BMP) 与西门 Epoc® 血液分析系统的性能比较。方法 Fluxergy 分析仪:Fluxergy 分析仪是一种快速、经济高效的多模态平台,可在一台仪器中完成实验室质量的 PCR、临床化学、免疫化学和细胞测量,如有需要,也可在一个试剂盒中完成。Fluxergy BMP:Fluxergy BMP 利用带有丝网印刷电化学传感器的 Fluxergy 检测卡,在 Fluxergy 分析仪上五分钟内快速量化全血中的主要电解质(K+、Na+、Ca2+、Cl-)和代谢物(葡萄糖、肌酐和 BUN)。可行性研究:利用在缓冲溶液中添加已知浓度的 K+、Na+、Ca2+、Cl- 和葡萄糖产生的假样品,进行了方法比较研究,以评估可行性阶段 Fluxergy BMP 的性能。使用 Fluxergy BMP 和西门的 epoc® 血液分析系统对样品进行了一式三份的测试,测试浓度为 epoc® 血液分析系统可报告范围内的三种不同浓度。结果 可行性阶段的 Fluxergy BMP 与 epoc® 血液分析系统相比,在 K+、Na+、Ca2+、Cl- 和葡萄糖的可报告范围内显示出很强的相关性(表 1)。除一个葡萄糖样本(9.5 mM)外,所有测试样本的误差率均小于 10%。除一个 Ca2+ 样品(0.44 mM)外,所有测试样品的方差系数均小于 10%。结论 这些可行性数据表明 Fluxergy 分析仪非常适合在 POC 对全血样本进行快速、准确的代谢测试。
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来源期刊
Clinical chemistry
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.
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