Abstract

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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