Last Updated July 5, 2020
Molecular testing is the gold standard of diagnostic testing for COVID-19. This highly accurate testing method uses “PCR” (polymerase chain reaction) to detect the presence of a virus. For COVID-19 testing, this method typically uses upper and lower respiratory specimens.
Molecular testing was the first kind of testing for COVID-19 available in the United States. A dozen ACLA member laboratories currently perform molecular testing for COVID-19. Since February 29, when FDA guidance first allowed high-complexity laboratories, including academic, hospital and commercial labs, to step forward with novel tests for COVID-19, ACLA members have performed millions of these diagnostic tests. For the latest number of tests performed, including daily totals, click here.
Serologic testing, also referred to as antibody testing, is used to analyze blood specimens for the presence of proteins, called antibodies, made in response to an infection. The presence of specific antibodies indicates that an individual has been infected by that specific pathogen. When used appropriately, high-quality serologic testing may help determine the number of individuals who have been infected with SARS-CoV-2 and inform public health strategies.
Serologic testing should not be used as a primary method of diagnosing COVID-19 in an acutely ill patient. However, accurate and reliable serologic testing is a valuable tool in a comprehensive response to the COVID-19 pandemic. Several ACLA member laboratories are currently performing serologic testing and continue to scale up capacity nationwide. To read more about ACLA’s position on the role of serologic testing, view our recent white paper on the subject.
The presence of antibodies in a patient’s blood demonstrates an immune response to infection – no one is debating that point. What we don’t know yet is the level or the duration of immunity against reinfection that these antibodies provide. The science and research continues to progress each day, and clinical laboratories are working closely with researchers and public health experts to piece together the complete picture of this evolving virus.
The value of antibody tests for COVID-19 is significant. High-quality serologic testing can help determine the number of individuals who have been infected with SARS-CoV-2 and inform broader public health strategies.
Antibody testing also has a vital role in supporting ongoing development of vital COVID-19 treatments and vaccines, and preliminary reports indicate that convalescent plasma transfusions from patients who have tested positive for these antibodies are providing relief to some of the sickest patients.
Patients may be most familiar with antigen testing as an initial diagnostic tool used at a hospital or doctor’s office to deliver rapid results for flu or strep throat. This test typically is performed at the point-of-care.
Antigen testing for COVID-19 can be used to quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity. While antigen tests deliver rapid results, these tests are not as sensitive as molecular PCR tests, and as a result, the FDA has cautioned that “negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.”
Rapid or point-of-care testing refers to testing that is done at or near where patients receive care, such as physician offices and ambulatory care centers. Point-of-care testing plays a vital role in our nation’s response to the pandemic, but this type of testing does have limitations. In general, point-of-care testing is less accurate than molecular PCR testing performed in laboratories. Another difference between point-of-care platforms and instruments that ACLA members typically use is volume; laboratory-based testing utilizes high-throughput platforms that process several thousand specimens a day.
Molecular PCR tests are both the most accurate and the most widely available diagnostic tests for COVID-19 in the United States. In physician offices, hospital settings and drive through sites, patient specimens are collected and sent to a laboratory where highly accurate results are typically reported within a few days. Rapid point-of-care tests also can be available in many of these settings. In addition, the FDA has authorized several at-home specimen collection kits for laboratory-based molecular tests. This method allows patients to collect their own nasal specimens, which then are sent to a laboratory for testing. At-home specimen collection is not currently available in all states due to local restrictions.
Currently, the FDA has not approved at-home specimen collection for serologic (antibody) testing or for antigen testing. Antibody testing, which requires a blood sample, is offered through many patient service centers, physician offices and other health care settings. The first antigen test was recently approved by the FDA. In addition, ACLA members are also working on innovative approaches to assist employers with return to work strategies, including on site specimen collection support.
Guidelines communicated to clinicians about who should be tested vary state to state. ACLA members are working closely with governors to deliver accurate, highly scalable testing through our 24/7 national network. ACLA members do not reserve testing capacity by state or region, but direct available capacity based on need so we can remain flexible to respond to outbreaks and hotspots.
Yes. Medicare Part B covers molecular and serologic COVID-19 tests with no cost sharing for beneficiaries. Medicaid programs are required to cover COVID-19 testing for beneficiaries, though some state programs have taken concerning actions to restrict coverage for certain tests.
All comprehensive health insurance plans must cover molecular and serologic testing, as well as any visit to the emergency room, doctor’s office or urgent care center that may have led to that testing.
Congress recognized the clear public health interest in broad access to accurate and reliable COVID-19 testing – that’s why lawmakers explicitly mandated that all health plans cover necessary COVID-19 tests with no cost-sharing, prior authorization or other medical management requirements.
Still, patients face barriers to access – and these barriers are compounded by a patchwork of vague testing guidelines, which vary by state. We’re also concerned that some plans may move to restrict coverage to these vital tests and deny coverage for individuals in certain circumstances – even those presenting with symptoms.
The continued inconsistency of COVID-19 testing coverage and reimbursement across private and public payers poses a direct threat to patient access to testing and undermines clinical labs’ ability to provide high-quality, reliable testing to each and every American who needs it, particularly the most vulnerable and high-risk members of our communities. HHS and CMS must ensure that coverage policies adhere to the requirements under law and that patients are not blocked from receiving necessary testing.
Fixing this patchwork system will require strong federal coordination and leadership, and ACLA is committed to being part of the solution.
As a result of the Families First Act, coronavirus testing and care is available without cost sharing to all patients, regardless of insurance status or economic circumstance.
ACLA is aware of concerning reports of patients receiving surprise bills after a non-COVID-19 test was used to rule out other conditions prior to a COVID-19 test being administered. Under current CDC guidelines, “clinicians are strongly encouraged to test for other causes of respiratory illness, for example influenza, in addition to testing for SARS-CoV-2.” As ACLA raised in our letter to the CDC in April, more information is needed to help providers understand what factors should be weighed when ordering these tests. Such clarification is essential to help protect patients from out-of-pocket costs associated with COVID-19 related care.
Guidelines communicated to clinicians about who should be tested is determined at the state-level and therefore varies state-to-state. The CDC recommends that clinicians use their judgment to determine whether a patient should be tested for COVID-19. The agency has also released guidelines to help inform these decisions and prioritize testing for patients who need it most.
12. What are labs doing to minimize disruption to non-COVID testing?
ACLA members are committed to providing patients with the essential tools they rely on to identify, manage and treat a range of health conditions. Laboratories are making adjustments to maintain predictable access to laboratory services for patients, and many ACLA member laboratories with patient service centers are designating special hours for routine testing for high-risk populations, such as seniors and those living with chronic health conditions.