FREQUENTLY ASKED QUESTIONS

General FAQ

The Fluxergy system is designed for robust and simplified point-of-use testing using a workflow optimized for minimal hands-on-time and rapid results. A typical test workflow is assay specific but generally involves the following steps:

  • • Mix Sample with the Fluxergy supplied Buffer
  • • Add Sample-Buffer mixture to test card
  • • Insert card in device and run test

The assay kits, aka Fluxergy Cards, supplied with the Fluxergy Analyzer contain everything required for an end user to run a test. Depending on the assay this may include a sample collection tool, buffer, test card and transfer pipettes.

The Fluxergy Analyzer is approximately 5” wide x 5” deep x 8” tall. We like to think the device is about as tall as a tissue box.

When purchasing the Fluxergy laboratory system, you will receive one Fluxergy Analyzer, 20 singleplex, analyte-specific Fluxergy Cards, a license for the Fluxworks software, and a custom Pelican case for easy transport and stroage. If you do not already have a device for Fluxworks, Fluxergy can supply a touch screen laptop for an additional charge.

Running a test on the Fluxergy system is assay-dependent, though in general typically has three primary steps. 1. Mix sample with reagent buffer. 2. Dispense buffer-sample mixture onto Fluxergy Card. 3. Load the Fluxergy Card into the Fluxergy Analyzer and run the test. For more information on assay specific workflows, please CLICK HERE and navigate to the specific test of interest.

The Fluxergy system can handle a variety of crude samples types depending on the assay being conducted. For PCR-based assays, The Fluxergy system currently accommodates whole blood, plasma, urine, saliva, tears, feces, nasal swabs, soil and plant tissue. Fluxergy has developed tests for a variety of species including human, equine, canine, feline, bovine, porcine and poultry. Please consult Fluxergy about a new sample type of interest HERE.

The length of a PCR test is highly assay dependent. A typical PCR test for a DNA target can be conducted in as little as 15 minutes while a RNA target averages 30-35 minutes for time to result.

While plugged in, the Fluxergy Analyzer can remain in the ON state indefinitely, though it is recommended to shut down the system while not in use. Fluxergy also can supply a special light weight power pack supplying 16 hours of run time on a single charge.

The Fluxergy Analyzer runs off 110V - 240V AC for use in different localities globally. The Fluxergy Analyzer can also be run on 12V DC for portable applications requiring power from a standard vehicle electrical system.

Yes, Fluxergy has designed the Fluxergy laboratory system to be used in any setting. The system can be battery-powered for up-to 16 hours of mobile field usage with the Fluxergy designed battery pack.

The Fluxergy system can be readily integrated into EMR/LIMS systems. If you are interested in learning more please contact us HERE.

Fluxergy assays have varying shelf-life dependent on the assay type. See the Assay Specification Sheet for a particular analyte on the Test Menu Page.

If you are interested in getting a Fluxergy system, please consider joining our Beta Program today for clinical veterinary and human RUO testing. See Test Menu. Additionally, if you are interested in implementing your benchtop assay onto our system or using our system for a new application consider joining the Developer Program for rapid integration.

Yes, the Fluxergy system can accommodate pre-validated 3rd party assays in addition to custom assay development. The Fluxergy developer platform allows for rapid assay integration onto the Fluxergy system for biological and chemical targets. CLICK HERE for more information regarding custom assay development.

The Fluxergy system has a wide variety of applications from medical diagnostics to astrobiology. The Fluxergy system enable detection of a variety of biological and chemical targets. Please CLICK HERE to learn more about the endless possibilities!

For PCR-based assays: Depending on the sample type and target, Fluxergy can translate an already existing assay onto the system in 4-6 weeks. More time maybe required for unique targets which are in sample types not already supported by the Fluxergy system.

Yes! Control up to 250 devices on a single network from 1 Fluxworks software computer interface. Devices can be daisychained together and integrated into LIMS and EMR systems for high volume testing.

The device is not FDA approved, however we do intend to FDA approve the system and a variety of assays in the near future. Additionally, we are currently getting our manufacturing facility ISO 13485:2016 approved for future CE marking and GMP compliance.

Technology FAQ

The Fluxergy system works by utilizing a modular design in both the analyzer and test card. The Fluxergy Analyzer is simply a highly sophisticated sensor system which can analyze the assay specific Fluxergy Cards. Each test card contains the necessary assay specific components for a particular assay to be completed (e.g. PCR, chemistry, immunochemistry, cytometry) including reagents, and mechanical components such as heat blocks, measurement electrodes, optics, etc. More information can be found HERE or feel free to contact us HERE.

For PCR reactions, we handle sample prep through our proprietary on card sample handling and buffer solution. This eliminates the need for costly and error prone manual sample preparation. Raw sample can be simply mixed with the analyte specific buffer and pipetted into the Fluxergy Card.

By using a highly modular system, Fluxergy’s device is capable of conducting a variety of assay modalities including: PCR, Chemistry, Immunochemistry, and Cytometry based assays.

Currently Fluxergy is focusing on releasing PCR based assays first, and the comprehensive test menu can be found HERE. Over the coming months, Fluxergy will be rolling out more assay modalities specifically chemistry, immunochemistry and cytometry based tests out of the same system. Keep an eye out with our Blog for the latest news.

Each Fluxergy Card is designed to test one single sample, and each Fluxergy Analyzer is designed to power and read one test card at a time. For higher throughput applications, up to 255 Fluxergy analyzers can be daisy chained and controlled by a single computer interface using Fluxworks. More information about the platform can be found HERE.

The volume of sample required to run a test is assay dependent, though can typically vary from 10 to 150 microliters. Fixed volume capillary transfer pipettes automate sample handling for ease-of-use in each assay. For more information on the sample volume for different tests, please CLICK HERE and navigate to the specific test of interest.

Each Fluxergy Card is designed to run one to many different analytes. For PCR test cards, up to six different analytes can be run on a single test card. Fluxergy is also currently developing technology to combine multiple assay modalities on a single test card. Think of a test card capable of measuring HIV viral load and also conduct a CD4 count, the possibilities are endless!

The Fluxergy system can detect both DNA and RNA targets. This includes mRNA, miRNA, genomic DNA, etc.

The Fluxworks software suite allows for data to be displayed in a format consistent with the user needs. In cases where a simple “yes” or “no” result to a test is needed (e.g. in a point of care medical diagnostic) the technician read out mode provides a clear and concise report of the result. In research cases where raw data needs to be viewed, the developer mode gives a comprehensive set of data visualization tools to understand the assay being run. For PCR tests, in developer mode one can view amplification curves, melt curves, set threshold values for Cq and melt peak temperatures, along with a variety of other data analysis and visualization functions.

The system can be both. Depending on the assay being conducted, the test results can readout as a quantity of analyte or state simply whether the target is present. For more information on the specific output for different tests, please CLICK HERE and navigate to the specific test of interest.

The Fluxergy optical system is ideally suited for the following emission and excitation ranges:

Excitation λ Emission λ
497 nm 525 nm
615 nm 650 nm

Specific fluorophores for real-time PCR are FAM, SYBR, and Tex 615. Additional colors are easily added and available upon request.

For PCRs, Fluxergy assures reliability through use of positive and negative controls. Fluxergy can manage positive controls of the assay by either conducting melt curve analysis for correct amplicon confirmation utilizing the Fluxergy Analyzer’s high resolution melt curve capability, or through multiple hydrolysis probe detection.