FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
FDA News Release
To facilitate the development of at-home, self-collection COVID-19 tests, the Food and Drug Administration (FDA) added a voluntary emergency use authorization (EUA) template to its website. This template indicates FDA's current view on the data and information that developers should submit to streamline the EUA process, as explained in FDA's guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised). This template includes recommendations for use by laboratories and commercial manufacturers that may use it to fast-track the preparation and submission of an EUA request. Developers can offer a COVID-19 test for at-home self-collection under EUA, and COVID-19 tests for at-home self-collection may also be used as part of an Institutional Review Board (IRB)-approved study. Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health, says: "Home collection raises unique concerns about safety and accuracy ... which is why these tests require FDA review, to ensure they work as they should and are safe for all involved." For at-home collection of samples, developers are generally required to submit a request for an EUA prior to distribution and use of such test. In cases where the developer has not obtained an EUA, these tests may be used as part of a research study in compliance with FDA's regulatory requirements for device investigations, including applicable requirements for an IRB review.
Preliminary Results to Nationwide SARS-CoV-2 Molecular Testing Survey Molecular Testing Survey
The April 2020 SARS-CoV-2 Testing Survey for clinical laboratories was created and administered anonymously by the Association for Molecular Pathology (AMP) to document the efforts and experiences of clinical laboratories. The survey consisted of 67 questions addressing such issues as methodology, performance, capacity, supply chain, regulatory, and reporting requirements. Of 118 representatives from U.S.-based academic medical centers, commercial reference laboratories, and community hospitals, 85 percent said they are currently offering SARS-CoV-2 testing to patients, while 10 percent said they are in the test validation phase. The survey also found that 90 percent of the laboratories recognize the need to further expand diagnostic testing capacity, and are working diligently to achieve this in the next few months. However, more than 70% of these laboratories said they have experienced supply chain interruptions ranging from a lack of RNA extraction kits, primers, probes, and enzymes to physical sample collection materials like swabs and containers. Some laboratories are being compelled to validate at least three different diagnostic testing methods at the same time in case supplies of reagents or materials are exhausted. AMP believes federal, state, and local governments should reassess where and what type of testing is needed, and ensure access to real-time resource availability and reagent and supply quantities. The organization also supports standardizing agency reporting formats and processes.
Antibody Tests for COVID-19 Wrong Up to Half the Time, CDC Says
Antibody tests used to determine if people have been infected in the past with COVID-19 might be wrong up to one-half of the time, the Centers for Disease Control and Prevention (CDC) said in new guidance. The tests are not accurate enough to use to make important policy decisions, according to CDC. Health officials or health care providers who are using antibody tests need to use the most accurate test they can find and might need to test people twice, CDC said in the guidance. "In most of the country, including areas that have been heavily impacted, the prevalence of SARS-CoV-2 antibody is expected to be low, ranging from less than 5 percent to 25 percent, so that testing at this point might result in relatively more false positive results and fewer false-negative results," CDC said. The higher the sensitivity, the fewer false negatives a test will give. The higher the specificity, the fewer false positives. Across populations, tests give more accurate results if the disease being tested for is common in the population. There is little evidence now about whether having been infected gives people immunity to later infection, but doctors worry that people will behave as if they are immune if they get a positive antibody test. "It cannot be assumed that individuals with truly positive antibody test results are protected from future infection," CDC said in the updated guidelines.