Q: Do I need a CLIA Certificate of Waiver to offer a Covid test?
A: Yes, anyone administering any Covid test to any person, including employees, must have a CLIA Certificate of Waiver.
Q: What does CLIA stand for?
A: A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a facility to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment.
Q: Where do I apply for a CLIA Certificate of Waiver?
A: Visit cms.gov, complete form CMS-116 to apply for a CLIA Certificate of Waiver, and contact your local state agency for further details. You can also click here for directions to apply for CLIA Certificate of Waiver and for helpful information. Once the form is completed, submit to your local state agency.
Q: How long does it take to get a CLIA Certificate of Waiver?
A: It depends upon your state health department, it may take up to 10 days or longer.
Q: For how long is the CLIA Certificate of Waiver valid?
A: 2 years.
Q: When can an office start performing testing?
A: After you apply for your certificate, you will receive a fee coupon. Follow the instructions on the fee coupon for payment. After your payment is received, your certificate will be mailed to you. You generally may begin testing once you have received your CLIA certificate, but you also need to check with your State Agency, since some states have additional state-law requirements.
Q: Where are Covid test results reported to?
A: All Covid test results are reported to state agencies, contact your local state agency for more details.
Q: Are there different types of Covid tests?
A: Yes, diagnostic testing (which include Molecular/PCR and Antigen) testing and Antibody testing.
Q: What is a diagnostic Molecular/PCR test?
A: Diagnostic test looks for an active virus infection, the Molecular/PCR detects genetic material and is a complex test.
Q: What is an Antigen test?
A: Antigen test is a simple non-complex test.
Q: What is an antibodies test?
A: An antibodies test looks for antibodies that are made by your immune system in response to a previous virus.
Q: What is average cost of an Antigen test?
A: The average cost of an antigen test is $10-$50.
Q: How quickly are results given for Antigen test?
A: Results are given in 10-15 minutes on average.
Q: Where can Antigen tests be completed?
A: Point of care facilities, dental offices, doctor offices, hospital or clinics.
Q: What is the average cost of a PCR/Molecular test?
A: $100 or more per test.
Q: How quickly are results given for a PCR/Molecular test?
A: 2-3 days, sometimes longer up to 7 days.
Q: How can I determine if a Covid test is reliable?
A: Check to see if the Covid test has an Emergency-Use Authorization by the FDA. Visit: FDA – EUA Covid Tests
Q: What are the different specimen collection types?
A: Nasopharyngeal (deep nasal) swab, nasal swab, saliva, and blood sample.
Q: What is the accuracy of these tests?
A: Percentages vary by test, look for Sensitivity and Specificity ratings. The higher the percentage the better the test.
Q: What does Clinical Sensitivity mean?
A: The sensitivity of a clinical test refers to the ability of the test to correctly identify those patients with the disease. A test with 100% sensitivity correctly identifies all patients with the disease, low probability of false positives.
Q: What does Clinical Specificity mean?
A: The specificity of a clinical test refers to the ability of the test to correctly identify those patients without the disease. Therefore, a test with 100% specificity correctly identifies all patients without the disease, low probability of false negatives.
Q: Are Covid tests returnable?
A: No, Covid tests are not returnable.
Q: Can a dental office submit a Covid test charge to insurance companies?
A: Yes, starting January 1, 2021, use procedure code D0604 Antigen test for public health– related pathogen, including coronavirus; D0605 Antibodies testing for public health–related pathogen including coronavirus.
Q: What should a dental office do if an employee or patient tests positive?
A: They should isolate and inform a healthcare provider and follow the CDC guidelines.
Q: Are there any sales restrictions on Covid tests?
A: Yes, the tests are regulated medical devices for use by a healthcare professional only and flagged as RX. These kits are not available for retail, cash or employee sales.