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
{"title":"A-368 Feasibility of a Five-Minute Sample-to-Answer Basic Metabolic Panel for Point-of-Care Testing on the Fluxergy Analyzer","authors":"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","doi":"10.1093/clinchem/hvae106.362","DOIUrl":null,"url":null,"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.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"23 1","pages":""},"PeriodicalIF":7.1000,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical chemistry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/clinchem/hvae106.362","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
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.
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.