AscencioDx Molecular Detector and COVID-19 Test
The AscencioDx® Molecular Detector is a rapid, highly accurate, easy-to-use and affordable clinical diagnostic platform for performing molecular analysis of patient samples in point-of-care (POC) CLIA-waived settings using the AscencioDx COVID-19 Test.
AscencioDx Test Target Technology:
- RT-LAMP molecular analysis
- Real-time SARS-CoV-2 viral RNA detection via fluorescence signals
- Novel enzyme and probe design (patent pending)
- Redundancy: detects 3 distinct regions of the SARS-CoV-2 viral genome, robust against mutation
- RNA internal control in every test flags problems due to sample mishandling
AscencioDx Exclusive Detector Portal:
Results are securely transmitted from the detector to Anavasi’s cloud-based portal via a QR-Code
- No Bluetooth required or app to download
- HIPAA compliant
- Automatically disseminates results to the CDC ReportStream, which in turn reports to in-program State and Local Health Agencies
- Eliminate the hassle of paper or cumbersome spreadsheets while easily and securely managing patient records on your dashboard
- Comprehensive report generation and customizable “Passport” style report templates
with option to upload your own template
AscencioDx Detector Portal Capabilities:
- A click of a button securely emails test results to a patient
- Provide individual portal access to patients so they have a secure record of all their COVID test results
- Results are also exportable in an excel format
- Patient information can be auto-populated by scanning their Driver’s License — reducing data entry errors and saving time
Reimbursement Codes & Documentation:
This information is being provided as a reference, for informational purposes only. It is the sole responsibility of the health care provider to verify reimbursement policies and select the appropriate CPT and ICD-10- CM codes to accurately reflect patient condition(s) and testing procedure(s).
Test Name: The AscencioDx COVID-19 Test
CPT Code: 87635
LOINC Code(s): 95409-9
CPT Code Description: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
(Coronavirus disease [COVID-19]), amplified probe technique
National Limit Medicare Coverage: CCI MUE
Medicare Reimbursement: $51.31
FEATURES & BENEFITS
- Cost-effectivene: Superior functionality and performance at an affordable price.
- Accurate: Highly accurate test results, minimizing chances of errors and enhancing diagnostic confidence. The AscencioDx COVID-19 Test targets three unique locations on the N-gene to minimize the risk of mutation escape.
- Easy & convenient: The CLIA-waived AscencioDx system is incredibly user-friendly and does not require extensive training, making it a suitable choice for all healthcare settings.
- Fast results: Receive actionable positive test results in as little as 20 minutes.
- Re-usable: This reusable device and its lightweight disposable components substantially decrease biowaste. This detector can be used > 4000 times.
- Compact size: Due to its size, this detector is portable and does not monopolize lab counter space.
Less than 2 minutes of hands-on time required to set up test
Uses lower nasal swab samples
Provides excellent variant coverage detecting 99.99% of all currently known variants and Omicron subvariants
Runs an internal RNA control on every test sample to confirm amplification
You may place order by giving us a call
|Catalog Number||Description||Units of Measurements|
|IDADX100000||The AscencioDx Molecular Detector – Individual||1 detector|
|IDADX100200||The AscencioDx Molecular Detector – Case (10 Detectors)||10 detectors|
|IDADX101100||The AscencioDx Molecular Detector – Master Pack (4 Cases)||4 cases|
|IDADX100400||The AscencioDx COVID-19 Test – Master Pack (40 Tests)||40 tests/pack|
|IDADXSTARTER||The AscencioDx COVID-19 Starter Kit – 1 Detector & 1 Test Master Pack||1 detector, 1 test/pack|
DOCUMENTATION AND VIDEOS
Brochure, package inserts and additional literature provided below:
Quick Video Instructions
Full Video Instructions
The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
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)(7) of the Federal Food, Drug, and Cosmetic Act, 27 U.S. C. §360bbb-3(b}(7 ), unless the declaration is terminated or authorization is revoked sooner.