fluxergy covid test

Human Diagnostics -> COVId-19

COVID-19 PCR Test Kit

Rapid and clinically-relevant results for your patients and community. CE-IVD approved for point-of-care (POC) PCR.

  • Detect Omicron and Delta Variants with bioinformatic analysis and 99.64% of all known variants. 

  • Sensitive RT-PCR testing within 1 hour. 

  • RNA extraction is not required.

  • Minimal hands-on time per sample.

  • Pool up to 10 samples for screening.
Get Started with Fluxergy

Only Fluxergy Test Kit COVID-19 has been approved for CE-IVD and is available for any markets that accept CE marking as the valid regulatory approval. All other products or any other markets are For Research Use Only (RUO) and are not for use in diagnostic procedures.

OVERVIEW
SPECIFICATIONS

USE CASES

FAQ

Testimonials

RESOURCES

Fluxergy's 1 Hour COVID-19 PCR Test: Approved for CE-IVD

The Fluxergy Analyzer system, which utilizes state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in 1 hour, with NO RNA extraction steps.

1. Place Prepared Sample
into Fluxergy Card

2. Insert Fluxergy Card into Fluxergy Analyzer

3. Get PCR Results in 1 Hour

Validated through Clinical Trials

100 % Sensitivity

Every  positive test sample was correctly identified in clinical studies.

100 % Specificity

Every  negative test sample was correctly identified in clinical studies.

99.64% Inclusivity

Our analyzer detects 99.64% of all known COVID-19 variants.

0.3 LOD

Our limit-of-detection is just 0.3 TCID50 / mL.

In a clinical comparison study of 95 NPS specimens, the Fluxergy Test Kit Covid-19 was 100% concordant with Cepheid’s Xpert
Xpress SARS-CoV-2 (the gold standard for COVID-19 RT-PCR at the Point-of-Care).

Test TypeDirect RT-PCR
Sample Preparation~3 min. from reagant thaw, No extraction required.
Sample TypeNPS in 3mL VTM
Required Sample Volume14 uL
Storage(Flux Card) 10° to 30°C, (Flux Reaction Mix) -10° to -30°C

Gene Targets 

Orf1ab polyprotein and N gene; Detects B.1.351 and B.1.1.7. variants (does not differentiate)
LOD0.3 TCID50 / mL
Analyzer Size 26.19 cm x 13.13 cm x 25.80 cm 
Analyzer Weight6.8 kg 
Power Input12VDC, 7A
Operating Temperature15° – 30°C 
Storage Temperature15° – 30°C 
Operating Humidity 10% – 85%
Computer Reqs. (Recommended)
OS must be 64-bit, Windows 10+. Intel i5 2.5GHz or equivalent, 8GB DDR4 RAM, HDD: 250 GB, Screen 1080p, USB: 2×2.0 port, Networking: Ethernet port

Ideal for Clinical and Community-Level Testing

doctor child

On-site care creates a high quality, case-by-case testing solution for:

  • Emergency Departments
  • Delivery Wards
  • Outpatient Procedures
  • Surgical Procedures

Setting up multiple Fluxergy analyzers allows for community-level testing in settings such as:

  • Testing Centers 
  • Airports
  • Workplace
  • Screening
  • Travel Certifications
  • In-Person School Testing

Frequently Asked Questions

The Fluxergy Test Kit utilizes state-of-the-art Sample-to-Answer-RT-PCR and microfluidics technology and can identify the SARS-CoV-2 virus in 1 hour.

Fluxergy’s simple workflow and compact analyzer is deal for use in clinics and laboratories. Enable access to point-of-care testing in physician’s offices, hospitals, and community clinics. Fluxergy’s rapid testing can compliment a laboratory’s throughput workflow. 1 hour PCR testing as a service provides valuable time in clinical and retail settings. 

What Experts Say About Fluxergy

“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. It’s really simple.”
Caroline Ignacio​
Caroline Ignacio​Laboratory Manger UCSD Department of Medicine, CFAR Translational Virology Core​
“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.”
Dr. David Smith, MD, MAS, FACP, FIDSA​
Dr. David Smith, MD, MAS, FACP, FIDSA​Professor of Medicine, Head of the UCSD Division of Infectious Diseases And Global Public Health Member of Fluxergy’s Advisory Board
"The Fluxergy platform’s speed, with results in one hour, and accuracy by using qPCR molecular technology are potentially strong benefits for clincal 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."
Lee B. Springer, PhD
Lee B. Springer, PhDLaboratory Director at C3 Clincal Consulting Services
“I learned of Fluxergy’s technology when I was at Boehringer Ingelheim, and I was impressed about the opportunity for this pointof- care testing platform. I am happy to be involved on Fluxergy’s advisory board where I can bring my 20+ years of animal health and R&D experience. One of the big advantages of Fluxergy’s technology is that it is very easy to use. When veterinarians see horses with high fevers, its important that they can understand quickly what is going on.”
Dr. Randolph Seidler, VMD, MBA
Dr. Randolph Seidler, VMD, MBAFormer global head of R&D and business development for Boehringer Ingelheim Animal Health and Member of Fluxergy’s Advisory Board
"Fluxergy's technology has a great potential to start a new era in the diagnostic field. Fluxergy's portable, user-friendly, and cost-effective PCR technology provides highly accurate results in less than an hour, which is needed to control the spread of infectious diseases."
Dr. Lucjan Witkowski, DVM, PhD
Dr. Lucjan Witkowski, DVM, PhDWarsaw University of Life Sciences
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