COVID-19 – Research Use Only

Detect SARS-CoV-2 in 60 Minutes

Learn more about Fluxergy’s qualitative real-time reverse transcription polymerase chain reaction (RT-qPCR) test.*

For Research Use Only (RUO). Not for use in diagnostic procedures.

Test Overview

• Simple Workflow designed for rapid testing

• Real-Time RT-PCR, RNA extraction NOT required.

• Minimal hands-on time per sample

• Assay Target: SARS-CoV-2 N-gene and orf1ab gene

• Sample: NP swab in VTM

• Limit of Detection (LOD): 0.89 TCID50/mL of sample

The UC San Diego physician-scientist research team that conducted the validation of Fluxergy’s COVID-19 test has been led by Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health. Dr. Smith is a member of the Fluxergy Medical Advisory Board. Fluxergy’s COVID-19 test has also been evaluated by Mass General Brigham.

For Surveillance Testing

Whether screening samples at your workplace or school: being able to have population monitoring tools in place, like 1-hour molecular testing, help to create a safer environment.

For Environmental Testing

Swab your environment to accompany your routine sanitation procedures. This is a workflow that anyone can learn, and a type of testing that has been shown to reliably detect RNA.

For Research Use

It is still critical to screen specimens for your specific research applications – whether that’s therapy development, discovery, and trials OR conducting epidemiological research on COVID-19.

Watch: Infectious Disease Expert Dr. David Smith Explains the Value of the Fluxergy Testing Platform

COVID-19 Test Kit Specifications

Assay Specifications

Test Type

RT-PCR, Direct

Time to Result

~60 minutes

Sample Preparation

~3 min from reagent thaw, No extraction required

Sample Type

NPS in 3mL VTM, See accepted VTMs*

Required Sample Volume

14uL

Storage Condition

Fluxergy Card COVID-19: 10° to 30°C

Fluxergy Reaction Mix COVID-19: -10° to -30°C

Gene Targets

Orf1ab polyprotein and N gene; Detects B.1.351 and B.1.1.7. variants (does not differentiate)

LOD*

0.89 TCID50/mL

*Request a copy of our Instructions for Use for data and results from our internal performance validation.

About the Platform

Fluxergy’s simple workflow on a compact analyzer makes it ideal for use in laboratory or field settings. Designed to deliver test results within one hour (15-60 minutes depending on the test). The Fluxergy Diagnostic Testing System consists of:

Fluxergy Reaction Mix

DNA or RNA-specific primer and probe sets that allow you to develop tests for genes of microbes, viruses, and more.

Fluxergy Card

A single-use, highly integrated consumable, allowing for rapid PCR results and simplifying tedious traditional workflows.

Fluxergy Analyzer

The Fluxergy Analyzer is a multi-functional lab device that can conduct real-time PCRs.

Fluxergy Works

Our cybersecure user interface capable of analyzing and disseminating data to users.

Platform Specifications

Analyzer Size

26.19 cm x 13.13 cm x 25.80 cm

Analyzer Weight

6.8 kg

Power Input

12V DC, 7A

Operating Temperature

15°C – 30°C

Storage Temperature

15°C – 30°C

Operating Humidity

10%-85%

Minimum Computer Requirements

• Operating System:

OS must be 64-bit

Windows 10 v1151

• Processor: Intel Core i5 2.5GHz or equivalent

• RAM: 8GB DDR4

• HDD: 250GB

• Screen: 1080p

• USB: 2 x 2.0 port (for scanner and mouse)

• Networking: Ethernet port

Data Analysis Tools

Qualitative Result Interpretation, Manual Amplification Curve Review

*Request a copy of to the Fluxergy Analyzer Instruction Manual for full specifications.

How to run a Fluxergy PCR

Fluxergy’s COVID-19 test, which utilizes state-of-the-art PCR and microfluidics technology, has been shown to identify the SARS-CoV-2 virus in one hour. With Fluxergy’s compact analyzer, it’s quick and easy to run a PCR test in your lab.

1. Place Prepared Sample into Fluxergy Card

2. Insert Fluxergy Card into Fluxergy Analyzer

3. Get PCR Results in 60 Minutes

What Experts Say About the Fluxergy Platform

"Two things about the Fluxergy system stand out, especially in the case of a viral pandemic: its accuracy using RT-PCR technology and its ability to deliver results in 1 hour at the point-of-care. When someone is in the emergency room and a person is coughing, you want to confidently know right away what that person has, whether its COVID-19 or Influenza."

"The Fluxergy platform’s speed, with results in one hour, and accuracy by using qPCR molecular technology are potentially strong benefits for clinical settings, especially when a quick result is needed. I also see the future value of the multimodal technology where you could potentially have different types of tests on a single point-of-care platform."

"I love the Fluxergy Platform – I really do. You take your swab, mix it with the Fluxergy Reaction Mix, you load that in the test card, you stick it in the analyzer, and you wait an hour and the test is done. I mean, it’s really simple."

Easy to Understand Test Results

In a real-time PCR assay, a positive detection of target nucleic acid is confirmed by accumulation of a fluorescent signal after the specific target DNA is amplified. Fluxergy Works software will output a qualitative positive, negative, or indeterminate result from your PCR test. This is determined by sensors that look for amplification/presence of the target gene (solid line) and an internal control target (dashed line). The internal control target monitors sample integrity and system functionality. If an indeterminate result occurs, it is recommended that you retest your sample.

Positive Result*

Both the target gene and positive control are amplified.

Negative Result*

Only the positive control target was amplified.

Contact Our Team About the Fluxergy Test Kit COVID-19*

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Detect SARS-CoV-2 in 60 Minutes