Updated May 18, 2022
Information on COVID-19 testing requirements and availability changes frequently. Clinicians are encouraged to review CDC and CMS resources along with the local public health and health system guidance for the most current information. Currently, with the surge in cases due to the Omicron variant, testing and contact tracing may be limited or unavailable.
Free COVID-19 Tests: U.S. households can order eight additional free at-home tests at COVIDTests.gov to slow the spread of COVID-19 variants.
The CDC has provided guidance on testing for clinicians. This guidance also provides information on the use of tests for surveillance as well as diagnosis. In general, diagnostic testing should be used for:
People who have tested positive for COVID-19 within the past three months and who do not have new symptoms don't need to be tested per CDC.
The number and types of available tests vary by geographic region and health care facility. Currently, testing sites include physician offices, local public health offices, healthcare systems, pharmacies, and community testing sites. Clinicians should be aware of the options available in their area.
The Federal Trade Commission has issued a warning about fake testing kits and fake testing sites. Get more information on how to check that a testing site is legitimate.
Three different types of testing are currently available:
Three CLIA certification complexity classifications can be given to a diagnostic test that is EUA designated.
To use for testing patients, you must have a valid CLIA certificate for your practice that matches your normal testing practices. Review a complete list of FDA authorized EUA tests as well as their CLIA classification.
The FDA has authorized the first non-presecription COVID-19 test that also detects the flu and RSV. Patients can take their own nasal sample without a prescription and send to Labcorp for results. The test can identify and differentiate multiple respiratory viruses at the same time.
On April 14, the FDA issued an EUA for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. Effectiveness was validated in a large study of 2,409 individuals, including those with and without symptoms.
Tests used for diagnostic purposes; use reverse transcriptase to create and amplify DNA from SARS-CoV-2 RNA.
Tests detect the presence of IgM and IgG antibodies against SARS-CoV-2, the virus that causes COVID-19.
IgM antibodies are the first to appear and are indicative of a new infection. But it can take days to weeks for these to appear; false negatives can be an issue. False positives are also a concern as there may be cross-reactivity with other coronaviruses. IgG antibodies usually takes at least 4 weeks to appear. These usually show if someone had a past infection but may not be a confirmation of immunity, as they do not measure the effectiveness of a memory response to reinfection. Scientists do not know how SARS-CoV-2 antibodies stay within the body after the infection has cleared.
Rapid COVID-19 tests and those that can provide results for patients in the physician’s office (point of care or POC) are appearing on the market. The AAFP supports POC testing that is accurate and reliable, and encourages physicians to stay informed about the tests offered for COVID-19 as the accuracy and reliability varies.
There are multiple tests that have been granted EUA for use in CLIA-specified laboratories. Three tests are now available for use in family physician offices as outlined above. Additionally, the CDC has provided guidance for POC testing.
To date, there are several home tests given emergency use authorization by the FDA. Please note that the sensitivity of these tests will vary based on the ability of patients to obtain optimal samples. Tests can be purchased at pharmacies or online although availability and prices will vary. Additionally, the federal government is providing free COVID-19 antigen tests (4 per household); consumers can order test online.
As noted above, rapid antigen tests can produce false negatives, so it will be important to obtain a PCR diagnostic test to confirm infection, particularly if prescribing therapeutics.
SARS-CoV2 Viral Detection: Compatible with molecular methods
SARS-CoV2 Antigen Detection
SARS-CoV2 Serology Antibody Detection: IgM and IgG antibodies for SARS-CoV2
Laboratories need a CLIA certificate to perform COVID-19 testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. To become CLIA-certified, laboratories must comply with the accuracy, quality, and reliability requirements as dictated by the statute.
The CDC has provided more specific information on laboratory testing, interpretation of tests, and FAQs .
The Centers for Medicare & Medicaid Services and the American Medical Association’s Current Procedural Terminology Editorial Panel are creating relevant codes to keep up with the evolving coronavirus testing environment.
The COVID-19 codes are generalized to capture any technique or target. However, determining the correct code for test procedures can be confusing. This quick reference guide can help you determine the correct code for the test procedure. You can also use the AMA CPT Guidance.