fluxergy covid test

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.

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.

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

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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

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Download Spec Sheets, Instructions, Troubleshooting Guides, and more. 

Get to know Fluxergy, our vision, mission, and values. Learn more by downloading our Corporate Deck. 

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