Platform for COVID-19 Testing - Medisynt Fluxergy

FAST PCR: DETECT SARS-COV-2

IN ONE HOUR

The Fluxergy Test Kit COVID-19, which utilizes state-of-the-art Sample-to-Answer-RT-PCR and microfluidics technology, has been shown to identify the SARS-CoV-2 virus in one hour. This device is solely intended to be used by healthcare professionals. Results were obtained from internal performance evaluation using clinical samples benchmarked against an FDA-EUA approved method.

Simple Workflow designed for rapid testing

Minimal hands-on time per sample

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

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

Assay Target: SARS-CoV-2 N-gene and orf1 ab gene

Sample: NP swab in VTM.

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.

Place Prepared Sample into Fluxergy Card

Insert Fluxergy Card into Fluxergy Analyzer

Get PCR Results in One Hour

SIMPLE SAMPLE PREPARATION

WITH NO EXTRACTION REQUIRED

Viral Transport Media

Vortexer (Not Included)

Fluxergy Reaction Mix

Mini Centifuge

Fluxergy Card

Fluxergy Analyzer

Fluxergy Works (Computer not included)

RNA extraction is NOT required. The Fluxergy Test Kit COVID-19, which utilizes state-of-the-art Sample-to-Answer-RT-PCR and microfluidics technology for a simplified workflow.*

1. Thaw & spin down Reaction Mix tube with mini centrifuge.

2. Vortex the swab sample in VTM.

3. Pipette sample into the Reaction Mix tube.

4. Gently flick the bottom of the tube 5 times & spin down.

5. Place the Fluxergy Card on a flat surface.

6. Carefully dispense master mix into the Fluxergy Card.

7. Press the plastic cap onto the Fluxergy Card.

8. Insert the Fluxergy Card into Fluxergy Analyzer.

9. Click “OK” on Fluxergy Works to begin the test.

10. The test will be complete in about 1 hour.

*Refer to Instructions for Use for complete user instructions for the Fluxergy Test Kit COVID-19. This device is solely intended to be used by healthcare professionals. Rev. 3-24-21

DETAILED SPECIFICATIONS

FLUXERGY TEST KIT COVID-19

Assay Specifications
Test Type	RT-PCR, Direct
Time to Result	~55 minutes
Sample Preparation	~3 min from reagent thaw, No extraction required
Sample Type	NPS in 3mL VTM, See accepted VTMs*
Required Sample Volume	14µL
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

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: 2x2.0 port (for scanner and mouse) Networking: Ethernet port
Data Analysis Tools	Qualitative Result Interpretation, Manual Amplification Curve Review

*Refer to the Fluxergy Analyzer Instruction Manual for full specifications. This device is solely intended to be used by healthcare professionals. Rev. 3-24-21

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.

COMMITTED TO COMPLIANCE:

CE-IVD, ISO 13485:2016, AND MDSAP

Fluxergy has obtained CE marking for its one-hour COVID-19RT-PCR test, to use by healthcare professionals as an in vitro diagnostics (IVD) for the detection of SARS-CoV-2. The CE-mark will allow Fluxergy’s innovative testing platform to enter the European Union market and any other markets that accept CE-marking as valid regulatory approval.

In December 2020, Fluxergy received dual ISO-1 3485:201 6 and MDSAP certifications. ISO 1 3485:201 6 is the medical device industry’s most widely used international standard for quality management systems to design, develop, produce, and deliver products. MDSAP certification satisfies the quality system requirements of the regulatory authorities participating in the program, including the U.S. Food and Drug Administration (FDA), Health Canada, Brazil’s Agência Nacional de Vigilância Sanitária and Australia’s Therapeutic Goods Administration.

Dr. Ali Tinazli, Chief Commerical Officer

“Fluxergy is dedicated to producing tools that make health information accessible and available to everyone. We are focused on bringing our unique diagnostic products to market rapidly and innovatively, ensuring our end-users always have a product with the latest technology while maintaining the highest level of quality.

We do this through a data-driven process that focuses on continuous improvement.

Fluxergy is seeking commercial partnerships with healthcare providers and potential international go-to-market partners in Europe, Asia, and Australia”

– Dr. Ali Tinazli, Chief Commerical Officer