COVID-19 Testing (GAO-20-584SP)

Summary

A GAO Science & Tech Spotlight on COVID-19 testing, GAO-20-584SP, dated May 2020, from GAO's Science, Technology Assessment, and Analytics team. It describes the three types of COVID-19 tests: molecular and antigen tests, which help diagnose active infections, and serology tests, which help determine whether someone was previously exposed to the virus. It states that all three kinds are commercially available under the Food and Drug Administration's emergency use authorization. As of May 13, 2020, FDA had authorized at least 56 molecular tests, which generally rely on PCR technology. It notes challenges with the use, availability and accuracy of tests.

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Science, Technology Assessment,
MAY 2020
and Analytics
WHY THIS MATTERS
As the nation works to save lives and flatten the curve
of COVID-19 cases, widespread testing could help
SCIENCE & TECH SPOTLIGHT: reduce the death rate, help identify those who should

COVID-19 TESTING
self-isolate, and help businesses recover. There are
challenges, however, associated with the use and
availability of tests, as well as with determining their
accuracy.

/// THE TECHNOLOGY How mature is it? All three kinds of COVID-19 tests are commercially
available under the Food and Drug Administration’s (FDA’s) emergency
What is it? There are currently three types of tests for COVID-19: use authorization (EUA), which allows for the use of certain unapproved
molecular, antigen, and serology. Molecular tests and a new antigen medical products or unapproved uses of approved medical products
test help diagnose active COVID-19 infections, and serology tests under certain circumstances during a public health emergency. As of May
help determine whether someone was previously exposed to the novel 13, 2020, FDA has authorized at least 56 molecular tests for COVID-19
coronavirus, which causes COVID-19. via EUA; these tests generally rely on PCR technology. Devices used
for administering molecular tests range in size from larger equipment to
How does it work? While each kind of test takes a different approach, smaller, portable devices that can be used on-site near the patient.
they all collect vital information about exposure to the virus.
On May 8, 2020, FDA authorized the first antigen test for COVID-19 via
Molecular tests amplify and detect genetic material from novel coronavirus EUA. According to FDA, antigen tests, which can be run in minutes, have
in a sample taken from a patient’s saliva, nose, or throat to determine a higher chance of false negatives compared to molecular tests. FDA
whether there is an active infection (fig. 1). For example, molecular tests states that negative antigen test results may need to be confirmed with a
based on the polymerase chain reaction (PCR) use a genetic photocopier, molecular test before making treatment decisions.
copying a unique portion of the coronavirus genetic material, if present,
until there are enough copies to detect. As of May 13, 2020, FDA has authorized at least 12 serology tests for
COVID-19 via EUA. For COVID-19, serology tests were first authorized by
Antigen tests can detect the virus by binding parts of the virus, called FDA about a month after molecular tests were authorized. Devices used to
antigens, to a membrane. Antibodies that can fluoresce are also added to administer serology tests also range in size, with some about the size of an
the membrane. If enough antigen is present to bind to the antibodies, the over-the-counter pregnancy test.
total fluorescence from the antibodies becomes high enough to indicate a
positive result. /// OPPORTUNITIES
Serology tests, which typically require a sample of blood from a patient, Testing provides critical information for a variety of purposes, including
can detect the presence of antibodies produced by a patient’s immune medical care, policymaking, and business. For example:
system in response to the coronavirus (fig. 1). Such antibodies can persist
in the blood after a patient recovers from an infection. Thus, a positive ■ Determining risk. Serology tests can help establish the percentage
serology test result indicates prior exposure to the novel coronavirus but of the population previously exposed to the virus. Such information
does not necessarily mean that the patient is still infected. can help improve the accuracy of statistics on infection rates, among
other things.

■ Understanding disease impact. Testing can help establish the
impact of the disease, including identifying those who may have
been exposed to the virus but did not show symptoms and those
who recovered. This is important for characterizing the risk of the
disease to the elderly and other subpopulations.

■ Guiding treatment and resource allocation. Molecular and antigen
tests can provide information on the rate and geographic location of
active infections. This can help guide patient treatment and inform
decisions about the distribution of medical supplies and equipment.

■ Informing responses. Testing is also important for informing
decisions on quarantine and isolation, including decisions related
to health care workers. Additionally, testing can help inform public
Figure 1. Most Common COVID-19 Test Types. Molecular tests detect viral genetic
responses such as school closures and reopenings.
material. Serology tests detect antibodies against the virus.

GAO-20-584SP COVID-19 Testing
Science, Technology Assessment,
and Analytics

/// CHALLENGES at-home sample collection kits. Allowing consumers to take their
own samples, however, could result in reduced test accuracy, due to
Although widespread testing offers a number of opportunities, there are sample contamination or other issues.
also challenges in implementation. For example:
/// POLICY CONTEXT AND QUESTIONS
■ Limited information on test accuracy. The performance
characteristics of some COVID-19 tests have raised concerns about There are a number of important policy issues related to COVID-19
test accuracy. In particular, available data suggest variability in the testing. For example:
rates of false positive and false negative results. This uncertainty can
■ What are the barriers, if any, to FDA’s and CDC’s ability to help
complicate patient treatment and public health decisions.
facilitate the development and use of tests during an early stage of
■ Number and timing of test results. Centralized laboratories an outbreak, and how could any barriers be addressed?
generally have higher reported testing throughput, but may take
days to report test results. Point-of-care testing conducted on-site ■ What actions could help the general public and health care workers
can return results more quickly, sometimes within an hour. However, understand and assess the accuracy and reliability of different tests?
the throughput of these tests can be lower than that of central
■ What information could help decision-makers determine the number
laboratories. It may be challenging to balance the need for fast
and distribution of tests to most effectively respond to outbreaks
results and the need for large numbers of tests (fig. 2).
such as the COVID-19 pandemic?

■ How can federal, state, and local health departments coordinate to
facilitate accurate and timely testing and reporting of test results?

/// SELECTED GAO WORK
In addition to ongoing work that will provide additional details on this topic,
GAO has previously issued the following products related to infectious
disease testing and COVID-19:

■ Science & Tech Spotlight: Social Distancing During Pandemics,
GAO-20-545SP.
■ Science & Tech Spotlight: Coronaviruses, GAO-20-472SP.

■ Medical Devices: Capabilities and challenges of technologies to
enable rapid diagnoses of infectious diseases, GAO-17-347.

■ Emerging Infectious Diseases: Actions Needed to Address the
Challenges of Responding to Zika Virus Disease Outbreaks,
Figure 2. Types of test processing based on site location. Decentralized testing, GAO-17-445.
including testing at the point-of-care, reduces the time to obtain test results but can have
limited throughput and other challenges. Centralized testing can have higher throughput, but /// SELECTED REFERENCES
may take longer to provide test results.
Library of Congress. Congressional Research Service. COVID-19 Testing: Key Issues.
■ Scalability. Expanding testing to reach more people would require IF11516. Washington, D.C.: Apr. 23, 2020.
greater availability of resources such as personal protective
equipment needed by health care workers. Another option for Sharfstein, Joshua M., Scott J. Becker, and Michelle M. Mello. “Diagnostic Testing for the
expanding testing may be for FDA to authorize the use of additional Novel Coronavirus,” Journal of the American Medical Association, vol. 323, no. 15 (2020):
pp. 1437-1438.

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Timothy M. Persons, PhD, Chief Scientist, personst@gao.gov the United States. The published product may be reproduced and distributed in its
entirety without further permission from GAO. However, because this work may
Staff Acknowledgments: Karen Howard, PhD (Director); Sushil Sharma, PhD,
contain copyrighted images or other material, permission from the copyright holder
DrPH (Assistant Director); Laura Holliday (Assistant Director); Chi Mai, PhD
may be necessary if you wish to reproduce this material separately.
(Analyst-in-Charge); Louise Fickel; Eliot Fletcher, PhD; Hayden Huang, PhD;
Anika McMillon, and Cindy Korir-Morrison, PhD.

GAO-20-584SP COVID-19 Testing

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