Description
Ascencio Healthcare Fact Sheet
AscencioDx Quick Reference Guide
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories. CLIA WAIVED
Contents: (40) Covid Test Kits, that include the following: Sterile, packaged anterior nasal swabs, Buffer Tube Screw-top vial of buffer fluid, Transfer Pipette Self-metering pipette for moving sample from the buffer tube into the reaction tube, Reaction Tube Bag Assembly Foil pouch containing a capped reaction tube containing a dried reagent pellet, along with a disposable desiccant pack, (1) Kit Tray Single-use tray to hold the nasal swab, buffer tube, reaction tube, and transfer pipette during test set-up.
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 59° – 86° F
Processing Time: Varies
CPT Code: 87635
The AscencioDx Molecular Detector is a rapid, highly accurate, easy-to-use medical device for conducting NAAT analysis of samples collected from patients in point-of-care (POC) settings with in vitro diagnostic supplies. It uses The AscencioDx COVID-19 Test. Specifically, the AscencioDx testing system uses reverse transcription loop-mediated isothermal amplification (RT-LAMP) for the qualitative detection of RNA from the COVID-19 virus in samples that are heated and illuminated (via fluorescence signals) in a reaction tube placed within the detector.
This patent pending design has a built-in redundancy where it detects 3 distinct regions of the SARS-CoV-2 viral genome making it robust against mutation. The detector runs an internal RNA control on every test sample to confirm amplification.
Test results are recorded on the detector’s display screen in 30 minutes or less. Test results can be securely transmitted to the Anavasi Diagnostics cloud-based portal via a smartphone or barcode reader through a QR code generated on the detector screen. No patient data is entered or stored on the detector.
PRODUCT HIGHLIGHTS & BENEFITS:
Rapid Results: Delivers test results in as few as 20-minutes, thus expediting decision-making and enhancing patient care. No need to wait for an inconclusive antigen test or wait for a lab test result to come back.
Environmentally Friendly: In line with our commitment to sustainable practices, this device has been designed to minimize environmental impact. This reusable device and its lightweight disposable components substantially decrease biowaste.
Compact Size: Due to its size, this detector is portable and does not monopolize lab counter space.
Easy and Convenient: This CLIA-waived system is incredibly user-friendly and does not require extensive training, making it a suitable choice for all healthcare settings. Transitioning from your current or previous COVID-19 testing platform is easy with minimal cost.
Efficient Reporting: The AscencioDx simplifies test reporting and patient records with its dynamic QR code scanning feature, which allows for effortless logging of test results to our cloud-based Detector Portal. Capturing test results and sharing data just became that much easier.
Quality You Can Rely On: AscencioDx is FDA EUA authorized and we proudly manufacture in the United States to meet our strict quality standards.
Versatile: The AscencioDx is expandable beyond COVID-19, with Influenza A/B, RSV, Streptococcus A, and Sexual Health panels which are currently in development.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
See product links above for additional information or contact your local Stat Technologies sales representative
