At-home SARS-CoV-2 diagnostic tests could be a breakthrough with possible limitations

May 13, 2020

The first SARS-CoV-2 diagnostic test with a home collection option by LabCorp received emergency use authorization (EUA) from the Food and Drug Administration (FDA) on April 21, 2020. LabCorp is initially prioritizing healthcare workers and first responders and then expects to make the tests available more broadly according to an article in by Brittni Frederiksen, Ivette Gomez, and Alina Salganicoff from the Henry J. Kaiser Family Foundation.

On May 8, 2020 the FDA granted a second EUA to Rutgers’ RUCDR Infinite Biologics for an at-home test using a saliva-based specimen. At-home tests may be a promising avenue to get more people tested in a timely manner and also reduce the risk of exposure in healthcare settings. An at-home SARS-CoV-2 test would not be the first at-home test for an infectious disease. For several years now, Americans have been able to purchase at-home sexually transmitted infection (STI) tests from online sellers, and experiences with these tests can offer some lessons on the challenges that we might anticipate with the widespread adoption of at-home SARS-CoV-2 testing.

Before the FDA authorized any at-home tests for SARS-CoV-2, several companies began development of at-home diagnostic tests. A few of the companies that were already offering at-home tests for STIs and other conditions (e.g. Nurx and Everylywell), jumped on the opportunity to develop and distribute at-home diagnostic tests soon after the FDA issued a policy to accelerate approval of diagnostic tests for COVID-19 in the early days of the outbreak.

However, on March 20, 2020 the FDA clarified that test self-collection and at-home tests were not authorized under the initial policy, so these companies subsequently discontinued the distribution of at-home tests, with some redirecting their tests to hospitals and healthcare providers or providing them though clinics.

Among the issues that have arisen are state level restrictions on at-home tests, accurate reporting of results to public health authorities, the ability of individuals to safely and correctly collect their own samples, as well as affordability and coverage. Lessons learned from at-home STI testing products highlight other logistical hurdles that could make the mass distribution of an at-home SARS-CoV-2 test challenging.

State policies blocking at-home testing: Existing state direct-to-consumer testing laws currently limit at-home testing in New York, New Jersey, and Rhode Island (which has been a barrier to the availability of STI at-home STI testing in those states). Many of these laws only allow tests to be ordered by licensed physicians and not consumers. LabCorp states that their new FDA-authorized at-home SARS-CoV-2 diagnostic test is not available in Maryland, New Jersey, New York, or Rhode Island, states with large numbers of COVID-19 cases and deaths.

·       Public health surveillance: The Coronavirus Aid, Relief, and Economic Security (CARES) Act requires every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 to report the test results to HHS. COVID-19 was also added to the Centers for Disease Control and Prevention’s (CDC) list of national notifiable diseases on April 5, 2020, which often prompts states or local jurisdictions to mandate reporting through law or regulation. Syphilis, chlamydia, gonorrhea, and chancroid are also national notifiable diseases. Most STI home-testing companies have individuals send in their samples, the lab reports the results of the test back to the individual, and the companies report the results to public health agencies that report to the CDC. OraSure Technologies, a company that is currently working on an at-home rapid diagnostic test for SARS-CoV-2 with federal support, has been offering a rapid at-home HIV test that provides the results to individuals without the need to send back a specimen to the lab. It has been up to the individual to contact a provider to confirm the HIV test results and that provider then reports the confirmatory results to the CDC. To keep track of how many people have been tested for SARS-CoV-2 and the prevalence of the virus in the community, at-home testing companies that run the results will need to be required by law to report the test results to public health agencies. However, if a test is developed and approved that provides results at home, unless there is a system of consumers to easily report the test results to public health agencies, we won’t get a full picture of test results and the number of community infections.

·        Home specimen collection: Many at-home STI tests are FDA-approved laboratory tests and are often sent to labs accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA). The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the CLIA. While there is concern that self-collected specimens may be more prone to variability and error in the collection (leading to inaccurate results), a systematic review and meta-analysis of self-collected vs. clinician-collected vaginal swabs and urine samples for chlamydia and gonorrhea found self-collected samples to be similarly accurate and a good option for those that otherwise might not be tested. Nasal swabs, particularly of the nasopharynx, the hard to reach cavity between the nose and the throat, may be more challenging to self-collect than those collected by a health care provider. Some companies are proposing saliva tests, which may make self-collection easier. Some companies proposing saliva tests, like the newly approved test from Rutgers’ RUCDR Infinite Biologics, may make self-collection easier.

·        Cost and Coverage: Historically, few at-home STI tests few accept private insurance or Medicaid. However, the Families First Coronavirus Response Act (P.L. 116-127), and the CARES Act require private insurance, Medicare, Medicare Advantage plans, Medicaid, and the Children’s Health Insurance Program to cover (without cost-sharing or other cost-containment measures) a SARS-CoV-2 test if the test has received an EUA from the FDA or if it is FDA-approved. LabCorp’s test received an EUA from the FDA on April 21, 2020. However, in addition to the costs of STI test kits ($24-$522), some companies charge a consultation fee that ranges from $10-$99 that is not covered by insurance. A few companies like Nurx accept private insurance in 28 states and DC and Medicaid in California, Illinois, and Texas, but consumers with insurance must still pay $75 for the kit contents and the processing. The FDA-approved LabCorp SARS-CoV-2 test costs $119 and as of April 30, 2020, they say they can file your insurance or utilize federal funds to cover the upfront cost of this test. Home-testing companies, however, historically have not accepted insurance for their other diagnostic tests, so a mechanism to charge insurers would need to be developed and implemented to make these tests more widely accessible once they are approved, particularly to low-income individuals.

Using platforms with these ready at-home tests is an attractive avenue to ramp up testing and reduce exposure of health care workers and individuals in the community. Because asymptomatic people may need diagnostic testing multiple times after potential exposure, an at-home test would be a convenient way to do broad scale testing. However, in addition to the many concerns about the accuracy of the tests, there are still challenges in assuring that individuals can easily and accurately collect their own specimens, and receive the financial protections that federal law now provides. Finally, there are not yet systems in place to assure that if rapid result at-home tests are approved, the results can be reported to public health agencies to be included in surveillance statistics and allow for contact tracing for people who test positive.

KFF has the report.

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