Frequently Asked Questions
Devon COVID-19 Testing Solution Questions
The tests we offer are currently approved by the FDA under its Emergency Use Authorization (EUA) or awaiting FDA EUA approval. Tests awaiting approval under EUA are submitted to FDA from the company and are currently under an examination process with the FDA. According to FDA guidelines, testing awaiting EUA approval can be sold and utilized throughout the U.S. under the supervision of a highly complex CLIA accredited laboratory. Devon Testing has partnered with many CLIA laboratories to conduct any tests that require this supervision.
The access Bio CareStart COVID-19 Fast Antigen Test FDA EUA approved to be used in point-of-care locations under a CLIA waiver certificate. In addition, the Bowditc COVID-19 Rapid Antibody Test is currently pending FDA EUA approval.
Our antigen test for rapidity has the sensitivity (actual positive rates) of 88.3 per cent and sensitivity (actual positive rate) of 100 per cent. The point-of-care test for antibodies can determine the positive or negative result with 96-97 per cent precision.
There is no universal method of testing. The testing strategies and frequency depend on the particular nature of the different sections of your workforce or community and industry/sector. Based on Devon’s expert medical advisory staff, We’ll assist you in determining the most effective testing strategy tailored to your particular needs and limitations and the most effective methods suggested by our experts.
The price of the program can differ based on the testing method and frequency. The program, however, can be designed to fit your budget goals.
We have formed an agreement with the manufacturer of our point-of-care test kits order to guarantee the availability of testing kits that satisfy the needs of our customers. Therefore, we are not anticipating any shortages.
Devon Testing has only saliva-based test kits for convenience and ease of use, requiring test subjects to give the sputum into a collection tube. However, the procedure is simple to explain, use, and support by teachers, parents, and even administrators.
As a test for point-of-care, We expect an FDA Emergency Use Authorization will allow the test to be administered by companies that are certified or exempted from the CLIA (Clinical Laboratory Improvement Amendments) regulations that the Federal government has enforced, and specifically those of the Centers for Medicare and Medicaid Services (CMS). Therefore, this Devon Community Health Testing program will be managed by technicians who have the necessary state and federal accreditations.
Test results will be sent to the healthcare professional using Our Devon Community Health cloud-based application. Test results may also be directly delivered to every test subject through this platform using a HIPAA-compliant mobile application. In addition, test results can be “pushed” electronically to other platforms when needed.
Our system is fully HIPAA-compliant so that you can be sure of the privacy of employees’ test results.
Based on your particular requirements depending on your specific requirements, we can offer customized COVID-19 testing solutions which include any of the following elements such as rapid COVID-19 test kits and, if needed, analyzers and PCR testing service to confirm tests cloud-based test management system to make it easier for large-scale deployments, a mobile application for self-service access to test reports and scheduling of tests as well as a turnkey mobile on-site test service, and for integration of the application with your business management system.
No. The tests we offer in rapid succession are designed for use in point-of-care environments. This means that testing procedures and collection of specimens are easy to perform and are easily performed by in-house medical personnel, such as School Nurses or Company on-site Medical Resources.
In addition to the cost, Devon testing will staff large testing groups when needed. e.g. Back to School scenarios.