Information on coronavirus testing options and availability is changing rapidly. Tests and specimen collection components remain in short supply and are being directed to areas of greatest need.
To date, no coronavirus tests have been approved by the 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 are needed to achieve FDA EUA status. Laboratories developing coronavirus 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 recommends giving testing priority to:
Persons identified by public health officials or clinicians as high priority include:
The number and types of available tests vary widely based on geographic region and health care facility. If a patient is suspected of having COVID-19 and tests aren't available, clinicians should work with local and state public health offices to determine where and how patients can access coronavirus tests in the community.
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 point of care 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 two at home tests given emergency use authorization by the FDA. The first test is a molecular test that received EUA in April 2020 and requires samples to be mailed back to the lab to undergo RT-PCR analysis. The second test is also a molecular test but one that can use real-time loop mediated amplification reaction to provide results to the patient following appropriate sample collection and use of testing kit. It received EUA on November 17, 2020.
Both tests require a prescription from a clinician. Please note that the sensitivity and specificity of these tests will vary based on the ability of patients to obtain optimal samples.
SARS-CoV2 Viral Detection: Compatible with molecular methods
SARS-CoV2 Antigen Detection
SARS-CoV2 Serology Antibody Detection: IgM and IgG antibodies for SARS-CoV2
Proper collection of specimens is the most important step in the laboratory diagnosis of infectious disease. A specimen that is not collected correctly may lead to false negative test results. The CDC listed the following specimens acceptable for diagnostic testing for SARS-CoV-2.
All swab specimens should be placed immediately in a sterile transport tube containing viral transport medium, Amies transport medium or sterile saline, unless using a POC test system which analyzes specimen directly.
For handling and testing clinical specimens, use standard precautions to provide a barrier between the specimen and HCP during specimen manipulation. Required PPE includes:
Employers should select appropriate PPE and provide it to HCP in accordance with OSHA PPE standards (29 CFR 1910 Subpart I). HCP must receive training on and demonstrate an understanding of:
Any reusable PPE must be properly cleaned, decontaminated, and maintained after and between uses. Facilities should have policies and procedures describing a recommended sequence for safely donning and doffing PPE.
If you are sending specimens directly to CDC or state health laboratory, check with your local health department for guidance on transporting and shipping of infectious substances. Most health departments have processes established to ship specimens to state labs or CDC. Suspected COVID-19 specimens must be transported according to International Air Transport Association (IATA) guidelines for infectious substances, category B.
Packaging must contain three components
Click on “Infectious substances” and download packing instructions. The Requisition for submitting specimens to CDC for lab testing form must be completed electronically to use the drop downs. Review guidance for completing the form.
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.