Information on COVID-19 testing options and availability is changing frequently. To date, no tests have been approved by the Food & Drug Administration (FDA). But tests are available under Emergency Use Authorization (EUA), which means the FDA has not thoroughly vetted these tests to grant full approval. There is limited information on the efficacy (sensitivity and specificity); a low threshold of detection studies is needed to achieve FDA EUA status. Laboratories developing COVID-19 tests may begin patient testing while their assays are under FDA review. Additionally, there are tests being marketed to physicians that do not have EUA status.
Family physicians should use their best clinical judgement to determine who should be tested. 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:
Fully vaccinated people and people who have tested positive for COVID-19 within the past three months with symptoms don't need to be tested.
The number and types of available tests vary by geographic region and health care facility. Clinicians should be aware of the options available in their area.
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.
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.
Tests used for diagnostic purposes; use reverse transcriptase to create and amplify DNA from SARS-CoV-2 RNA.
NOTE: The FDA has issued an alert that some molecular tests may be impacted by the new variant of SARS-CoV-2, B.1.1.7. View more information.
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. View more information on sample collection and test results.
In March 2021, the FDA authorized the first at home test available without a prescription. This test can be purchased in many areas, though costs may vary.
SARS-CoV2 Viral Detection: Compatible with molecular methods
SARS-CoV2 Antigen Detection
SARS-CoV2 Serology Antibody Detection: IgM and IgG antibodies for SARS-CoV2
ALERT: Becton Dickinson (BD) Max System has found to produce false positive SARS-CoV2 results. View the FDA's statement to health care professionals. (7/10/20)
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 purpose of these requirements is to ensure that the information that patients or their clinicians receive from a clinical laboratory is accurate and reliable test results. No requirements are being waived in response to COVID-19. However, to expedite access to testing CLIA is allowing for testing to begin once a CLIA number has been assigned as opposed to laboratories waiting for a hard copy paper certificate to come in the mail.
CMS has provided updated guidance on available tests and the level of lab required for testing.
On June 4, 2020, the U.S. Department of Health and Human Services (HHS) announced new guidance for reporting COVID-19 testing. This guidance is pursuant to the CARES Act and impacts all laboratories that are performing or analyzing tests intended to detect SARS-CoV-2 or diagnose possible cases of COVID-19. The goal of this new guidance is to standardize the required reporting information to better monitor disease incidence and trends. Laboratories are now required to report the results from each test to the HHS Secretary of the via existing public health channels to ensure rapid initiation of case investigations.
For detailed information, see Data Reporting Deadline side bar or the following resources:
CDC and FDA release Lab Alert: PrimeStore® Molecular Transport Medium (MTM) – an approved transport media for COVID-19 diagnostic swab samples – contains guanidine thiocyanate, which produces a chemical reaction releasing cyanide gas when exposed to bleach (sodium hypochlorite).
The PrimeStore MTM transport media being provided by state health departments is labeled at the bulk box level, but individual vials lack labels and therefore should be handled with caution. Do not use PrimeStore MTM with platforms that include a disinfecting step that uses bleach
For detailed information, see the side bar or the following resources:
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.