VF Wellness USA and CUE Health. AMERICA'S ONLY FDA APPROVED 99% accurate molecular test for Covid-19 novel coronavirus with results in less than one hour
ALL TEST TYPES ARE ALSO AVAILABLE INDIVIDUALLY
VF Wellness has actively responded to the global pandemic of COVID-19 through science, software, scale and speed. We have created a solution architecture that is innovative, data-driven and allows for societal re-entry. It consists of three elements: Screen, Treat, Inform.
We employ all four FDA Emergency Use Authorization tests for our clients.
- CUE Health 99% accurate molecular test for Covid-19 novel coronavirus with results in less than an hour.
- Rapid-Result Antigen diagnostic tests with 95+% accuracy delivered in 15 minutes
- 100% accurate Viral Testing (RT-PCR) with 24-48 hour turnaround
- Rapid-Result Antibody (Serology) Testing with results delivered in less than 10 minutes.
Patients testing positive are provided with next-step protocol guidance with medical health professional via telehealth follow-up.
CUE Health: Molecular Testing at the Speed of Life
Cue is a connected, molecular diagnostic system.
The Cue Health Monitoring System is a rapid, compact, highly portable testing platform with no compromise in performance or accuracy. It uses molecular diagnostic technology to deliver reliable results in about 20 minutes. Cue’s rapid, accurate, lab-quality, molecular testing changes how people, organizations, and communities protect human health—where and when it’s needed the most.
- REAL TIME RESULTS: Accurate results delivered in about 20 minutes, empowering you to respond equally as fast.
- ACCURATE DATA: Highly sensitive, specific testing capabilities ensure you always have the most reliable molecular results.
- SEAMLESS IMPLEMENTATION: Fully automated and designed to be easily administered with minimal training in point-of-care settings.
Efficient, accurate results whenever, wherever.
The portable, compact, battery-operated Cue Cartridge Reader activates the Cue Cartridge and communicates results directly to the Cue Health App in about 20 minutes.
VF Wellness provides safe testing platforms for large groups, businesses and organizations.
WE COME TO YOU.
Quidel SOFIA2 Rapid Result Antigen Tests
VF Wellness has been chosen as one of the initial providers of Covid-19 antigen testing. SOFIA2 being used by both MLB and NBA for rapid result platform.
- Accurate results in 15 minutes.
- Uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2.
- Provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
- Employs automated tracking, data capture, government reporting, and exclusive disease mapping.
- Emergency Use Authorization by FDA
- FDA EUA lab approval (April 10, 2020) for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test) under Section 564(c) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3)
- The oral swab method was found to be more accurate than the nasal swab
- Viral testing is 99% accurate in identifying an active infection though extraction of viral RNA from human DNA
- Open testing architecture ramping up to 250,000 daily volume by Mid-June 2020
- Three test & collection capabilities:
- In-home self-collection
- Test-site set-up
- Supply existing test-sites
- 48-hour turnaround
- All results and communication handled through proprietary smartphone app. Access from any smartphone, tablet, computer
- Healgen Antibody Test awarded FDA Emergency Use Authorization (EUA) on May 29, 2020
- Read Results at 10 minutes
- IgG Accuracy: 98.6% (95% Confidence Interval: 92.3%-99.96%)
- IgM Accuracy: 92.9% (95% Confidence Interval: 84.1%-97.6%)
- No special equipment or facilities needed
- High specificity and sensitivity
VF Wellness Provides
Customized collection tools and process.
Return results in 24-48 hours.
US manufacturing decreases supply chain barriers.
Infections tracked and reported via innovative technology; Navigation of patients to quality tele-healthcare after receiving a positive Sars-Cov-2 diagnosis.