What is the accuracy of the tests and are they FDA authorized?
The PCR test kits that Visit utilizes average almost 98% specificity and 95% sensitivity based on manufacturers' published literature with aftermarket studies even more impressive - finding that specificity and sensitivity approach 99-100% in those analyses. The antibody tests we use have demonstrated a sensitivity of 88.6% and specificity approaching 98% in the manufacturer's published literature. Due to the rapid emergence of the coronavirus epidemic, no test for COVID-19 has gone through the multi-year process to gain full FDA authorization, but dozens have now received Emergency Use Authorization (EUA) Including our PCR test. Our antibody test is registered with the FDA and has been validated by our CLIA-certified for High Complexity Laboratories pending application to FDA for EUA.
How will you guarantee materials and staffing availability?
Because our team has decades of experience staffing some of the largest hospital systems in the country, meeting the needs of our clients will not be a logistical or staffing issue for us. Because of our relationships with the larger medical supply companies, we do not anticipate having issues with PPE or obtaining reagents, viral transport media, and swabs (even if there is another shortage in the US).
How will the testing data be handled? Who is responsible for reporting results?
The participants sign a consent form, which waives their HIPAA privacy rights only for the results of the test to be shared with the organization for which the participants are associated as well as local and State Public Health Officials. Each participant is given a unique test ID, which is what is used on sample collection materials. Otherwise, any patient information and results are only on our lab's HIPAA compliant web portal. All test results will be reported to local and State Health Departments in the manner described by your home state guidance and requirements - this is typically managed by our laboratories.