COVID-19 Requires a Complementary Testing Approach

August 17, 2020

While scientists are working at breakneck speed to develop effective vaccines and treatments, diagnostic testing — along with mask wearing, social distancing and contract tracing — remains one of the first lines of defense against COVID-19.

The scale and speed at which tests to detect COVID-19 have been produced is greater than any other test in the history of modern medicine. Since Roche began shipping tests on March 13, we have increased our capacity three-fold. Collectively, the diagnostic industry provided the U.S over 20 million diagnostic tests in July1. This is an impressive number, especially considering that during the ENTIRE 2019-2020 flu season, U.S clinical laboratories reported just 1.5 million lab tests to the CDC.2 The amount of tests produced represents an unprecedented industry response, but – similar to our approach to annual flu season testing ­– it should not be the only response.

 

Testing is not “one-size-fits-all”

High-volume molecular diagnostic testing is and will remain the backbone of the country’s COVID-19 testing response, but it cannot be the only option. There are several complementary testing solutions needed to address unique applications and environments.

  • Point of care molecular testing solutions leverage the same technology as in the lab, but can be conducted at clinician offices, Urgent Care settings, Emergency Departments, and community pharmacies — providing healthcare providers with fast answers that can help determine a course of action or treatment for a patient very quickly. While the availability of rapid testing solutions for COVID-19 is currently limited, the arrival of new types of these tests is expected.
  • Antigen-based viral tests are another type of rapid test that can be conducted both in a lab or at the point of care. Antigen tests quickly detect fragments of proteins found on or within the virus using a nasal or throat swab. Similar to rapid strep or flu tests that are administered in the clinician’s office, antigen tests can provide results within minutes. While antigen tests don’t provide the same level of accuracy as PCR testing, they are a good tool in settings where PCR may not be readily available and can be used in conjunction with reflex testing. There are two antigen tests that have already received Emergency Use Authorization from the FDA, and as more become available this type of testing can provide a first line of defense to COVID-19.
  • Antibody tests, which are more readily available than diagnostic tests and can be performed both in the lab and at the point of care, can be a powerful tool for understanding past exposure. While antibody tests do not detect current infections, and evidence of antibodies to SARS-CoV-2 is no guarantee that COVID-19 will not recur in an individual, such tests can provide at least some reassurance to people previously exposed to the virus, and insights to employers on the aggregate exposure of their teams. It is important to stress that antibody test results should not be used as a tool for determining whether immunity exists for individual people. New research is surfacing almost daily from the scientific community to better understand the role of antibodies in providing protective immunity to SARS-CoV-2.
  • Multiplex tests can simultaneously tell if a patient has more than one disease and will become more important with the looming flu season. COVID-19 and the seasonal flu present similarly and may be difficult to identify based on symptoms alone. A test that can tell if a patient has the flu — or if it is indeed COVID-19 — will help physicians determine the most appropriate treatment, whether that is an antiviral prescription in the case of flu or isolation practices for COVID-19.
  • Specimen pooling is a process that combines respiratory samples from several people and conducts a single test on the combined pool. If a pooled test result is negative, then all the samples can be presumed negative. If the pooled test result is positive, each of the samples in the pool would be tested individually to determine which samples are positive. Pooling allows laboratories to test more samples with fewer testing materials, which could be useful in scenarios like returning groups of workers to a workplace.

 

There is no question that the diagnostics industry will continue to bring innovation to COVID-19 testing. Working together with a shared purpose that is led by science and public health, we will do everything we can to make sure people have access to the tests they need.