Now Approved for CE-IVD: Diagnose COVID-19 On-Site in 60 Minutes
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.
• 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): 0.89 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 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.
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
~3 min from reagent thaw, No extraction required
NPS in 3mL VTM, See accepted VTMs*
Fluxergy Card COVID-19: 10° to 30°C
Fluxergy Reaction Mix COVID-19: -10° to -30°C
*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.
A single-use, highly integrated consumable, allowing for rapid PCR results and simplifying tedious traditional workflows.
The Fluxergy Analyzer is a multi-functional lab device that can conduct real-time PCRs and more.
Our cybersecure user interface capable of analyzing and disseminating data to users.
26.19 cm x 13.13 cm x 25.80 cm
12V DC, 7A
15°C – 30°C
15°C – 30°C
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.
1. Place Prepared Sample into Fluxergy Card
2. Insert Fluxergy Card into Fluxergy Analyzer
3. Get PCR Results in 60 Minutes
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.
Both the target gene and positive control are amplified.
Only the positive control target was amplified.