Now Approved for CE-IVD: Diagnose COVID-19 On-Site in 60 Minutes

CE Transparent
IVD - Transparent

Potential environments for rapid testing applications include emergency rooms, outpatient procedures, urgent care, workplace screening, mobile testing, community level testing settings, school reopenings, and tourism. Fluxergy’s easy-to-use qualitative RT-qPCR test can detect SARS-CoV-2 in one hour.

*Approved for CE-IVD. All other regions are for research use only. This device is solely intended to be used by healthcare professionals.

Test Features

• Simple Workflow designed for rapid testing

• Real-Time RT-PCR with no extraction 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): 0.3 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.

Hospital Testing for COVID-19

For Clinical Use

For physician’s offices, hospitals, and community clinics. Enable access to point-of-care testing for your patients – a simple way to test in the emergency room, for elective surgery, and general care.

Laboratory Testing for COVID-19 - Fluxergy Analyzers at UCSD

For Laboratories

Gain the ability to conduct rapid testing that can compliment your high throughput workflow. 1-Hour PCR testing as a service can provide valuable time in clinical and retail settings.

For Community Testing

Whether for workplace screening, travel certificates, or reopening our schools, 1-hour PCR testing can provide a clear and fast result.

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*

0.3 TCID50/mL

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

About the Fluxergy Analyzer System

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. 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 and more.

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%

Computer Recommended 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

*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. See how easy it is to run a PCR test in your lab with Fluxergy’s compact analyzer.

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1. Place Prepared Sample into Fluxergy Card

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2. Insert Fluxergy Card into Fluxergy Analyzer

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3. Get PCR Results in 60 Minutes

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 or negative 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. 

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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