A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Therefore the ORAL RAPID ™ must undergo clinical validation studies individually in high-complexity CLIA certified laboratories. It cannot be designed or manufactured completely, or partly, outside of your laboratory
Since this is an American laboratory validated device, we have taken extensive measures to ensure that this 15 Minute SARs-CoV-2 Oral Rapid ™ Antigen Test Device is fully compliant and can be sold and administered in the USA by high complexity laboratories and their healthcare provider partners.
Summary of Recent Changes
Revisions were made on December 5, 2020 including:
Our pricing schedule for healthcare providers, distributors, and other high complexity laboratories allows for low MOQs, large bulk or monthly volume pricings, and most importantly stability during a very volatile environment..
For your clients, we handle regulatory compliance aspects on your behalf:
1. Ensuring contract for HIPAA compliance is conducted and on file
2. Ensuring that the staffing agreement tying the test centers into our high complexity laboratory is conducted and on file
3. Ensuring streamlined ordering process for all different client basis; including, but not limited to Healthcare providers, Distributors and high complexity laboratories complete with individual logins
4. Ensuring Training for software training and documentation with the high complexity laboratory and ongoing support
Possessing a proprietary software for the testing sites, ensuring the distributor, laboratory and the testing center remain fully compliant with LDT & HHS/CMS regulations:
1. Every single test picture is uploaded, and our laboratory director (and his team) reviews every test result and formally provides a test result diagnosis.
2. Our Staffing agreement provides the framework to allow for your staff to become an extension of our High Complexity Laboratory enabling the staff to collect samples on the behalf of the lab.
3. Staff and sales representatives will be trained by our high complexity laboratory ensuring the appropriate use of this device.
By virtue of this complete package each testing site will be an authorized extension of a high complexity laboratory(s).
Our proprietary software will do the following for YOU:
A. Automatically report all applicable results to local and federal authorities.
B. All patients can be easily scheduled and load balanced based on the number of providers and number of patients or employees saving countless needless scheduling hours.
C. Critical data can be transferred to local healthcare departments in order to initiate Contact Tracing.
D. Positive or inconclusive tests can easily be scheduled for PCR testing
E. All CPTS codes are present, and insurance can be billed in conjunction with the laboratory
F. Future developments entail Vaccine results with Antibody and Antigen systems.
Physician of Record Service
As an add-on service, we also offer a physician of record service for insurance billing requirements. We also offer this service for test centers, employer staffing agencies or other licensed entities who require a medical doctor for speciality regulatory aspects on a multi-state level.
We have contracts with some of the largest and most reputable medical staffing agencies in the world who are well versed with our device and are available to provide licensed medical professionals for employer organizations or testing sites who require additional services at a nominal fee included in the purchase of the device.
If you would like to read up on additional information on the Laboratory Developed Test pathway (LDT) please refer to the following links provided by the FDA.
You can find formal acceptance by the FDA & CDC for Laboratory Developed Tests here https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
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