Testing for the novel coronavirus in the United States has sparked confusion, controversy, and division. Testing inaccuracies, strict regulatory processes, supply shortages, and lack of federal guidance have stalled the nation’s adoption of a cohesive testing plan. In spite of these challenges, testing capabilities have gradually increased over the past month, following temporary, federal deregulation efforts and the expansion of testing options.
The United States lagged behind the rest of the world in both its acknowledgment of the coronavirus pandemic and its response efforts. Regulatory processes and FDA approval initially allowed for diagnostic test kits to be produced only by the CDC, resulting in massive test shortages across the nation. To preserve valuable supplies, decision-makers implemented strict requirements for testing — both for laboratories developing the tests and for patients requiring the tests — which further slowed the nation’s response to the rapidly intensifying pandemic. In February, the FDA responded to concerns about test shortages by relaxing certain regulations for the development of SARS-CoV-2 tests.
Polymerase chain reaction (PCR) tests for SARS-CoV-2 are currently the most common type of test used to identify the active infection of symptomatic individuals. PCR tests identify an antigen, utilizing an advanced laboratory technique called amplification to determine the presence of genetic material in a sample taken from the patient’s nose or mouth. Since antigens are present in the body before an individual presents symptoms, these tests are invaluable for their ability to provide very early disease detection.
However, PCR tests are not without faults. Incredibly labor-intensive, PCR tests require certified laboratories with specific PCR capabilities and highly-skilled technicians. According to an article published by Verdict:
False negatives can occur up to 30% of the time with different PCR tests, meaning they’re more useful for confirming the presence of infection than giving a patient the all-clear.
Additionally, these tests only provide accurate results for individuals with active infections and do not indicate immunity for patients.
The second most common form of testing for the novel coronavirus is serologic testing. These blood tests identify specific antibodies, providing valuable population health insights about herd immunity. Since antibodies are produced several days after initial infection, typically present once the body clears itself of the virus, some serologic testing cannot be used for early diagnosis. It is important to note that the presence of SARS-CoV-2 antibodies does not indicate guaranteed immunity nor does it promise that an individual is no longer contagious.
Various types of rapid tests are currently being evaluated. Both PCR and serologic tests require complex processes and specialized laboratory equipment, impeding testing capabilities. Lateral flow assay (LFA) tests and rapid, point-of-care antigen tests appear promising. LFAs are simple, inexpensive, and can test multiple sample types for the presence of a specific biological marker. Their durability makes them an appropriate choice for home-use. Rapid, point-of-care antigen tests would allow physicians to quickly intervene when an individual tests positive for COVID-19.
On April 1st, the FDA authorized the first SARS-CoV-2 rapid antibody LFA test for immediate use. The test is produced by Cellex and provides results in approximately 15 minutes. Early detection and intervention are imperative for successful containment, though it is not yet known if production capabilities can sustain the nation’s need. There are currently over 30 clinical tests that have received emergency use authorization (EUA). A number of these are being curated on our platform.
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