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April 23, 2020

COVID-19 Testing: Key Issues

The COVID-19 pandemic is affecting communities
throughout the United States, with the country reporting the
highest number of cases and deaths from the disease
globally. Containment and mitigation efforts by federal,
state, and local governments have been undertaken to
flatten the curve-that is, to slow widespread
transmission that could overwhelm the nation's health care

Diagnostic testing is a critical part of the clinical
management of COVID-19, caused by the SARS-CoV-2
virus. In addition, both diagnostic and serology testing at
scale may be a key component of efforts to ease mitigation
measures prior to the development, manufacture, and broad
distribution of a vaccine or effective therapeutic. Efforts in
the United States to rapidly develop, scale up, and
disseminate testing for COVID-19 have faced challenges,
including supply chain issues; a shifting regulatory
landscape; a lack of consensus around federal coordination
of or strategy for testing; concerns with the accuracy of
both molecular and serology tests; an early lack of data on
test results and capacity; and a delayed ramp-up by
commercial laboratories and test manufacturers of both
centralized and point-of-care testing. In addition,
manufacturing and quality issues with the nation's initial
test-developed by the Centers for Disease Control and
Prevention (CDC)-resulted in significant delay in early
access to testing throughout the country. For more
information, see CRS Report R46261, Development and
Regulation of Domestic Diagnostic Testing for Novel
Coronavirus (CO VID-19): Frequently Asked Questions.

Public health testing may be used to help identify and
contain the spread of a novel pathogen early in its
introduction into the country, as well as to detect and
monitor ongoing outbreaks. This testing relies on the CDC
and the U.S. network of state and local public health
laboratories, including some Department of Defense and
international laboratories. In contrast, clinical diagnostic
testing is carried out by a number of facilities, including
private commercial laboratories (e.g., LabCorp); hospital
and other clinical laboratories; and laboratories in academic
medical centers and universities. These two systems, while
overlapping and connected, have distinct purposes. Clinical
testing may be centralized-a sample is collected and sent
to a central laboratory for testing-or decentralized, or
occurring at or near the patient or point of care, commonly
referred to as point-of-care testing.

Diagnostic testing for COVID-19, in part because it is
caused by a novel pathogen, was initially carried out by the
country's network of public health laboratories. However, it
is generally not the role of the public health laboratories to

carry out the large-scale clinical diagnostic testing needed
during a pandemic response, and demand outstripped
supply quickly as the country transitioned to community
spread. The commercial sector-including commercial
laboratories and commercial test kit manufacturers-as well
as clinical laboratories in hospitals and at universities are
seen as critical to achieving the scope of testing needed
during the COVID-19 public health emergency. Despite
ramping up capacity across U.S. laboratories of all types,
the country's network of laboratories continues to face
challenges meeting the unprecedented demand for testing,
in terms of volume, speed, and accuracy. Currently the
country performs approximately 150,000 tests per day, and
a significant increase in capacity would likely require
additional infrastructure (more testing platforms, standing
up additional laboratory facilities), in addition to
maintaining testing at full current capacity.

Testing for COVID-19 currently involves both molecular
tests and immunoassays. Diagnostic testing for COVID-19
generally relies on molecular tests that use nucleic acid
amplification techniques such as polymerase chain reaction
(PCR) to detect viral genetic material. These tests identify
viral nucleic acid in samples taken from individuals' noses
or throats using swabs. This type of test is technically
complex but well-characterized, generally requiring both
specific instruments and highly trained laboratory
personnel. PCR tests may be high-throughput, so many
samples may be run simultaneously, but the run time is
generally several hours. PCR tests may be laboratory-
developed tests (LDTs), test kits, or point-of-care tests.
Point-of-care tests are usually faster and simpler to run, but
often only run a single or a few samples at one time.

COVID-19 testing may also be carried out using
immunoassays. This type of test detects immune system
proteins made by the host (antibodies) or viral components
that stimulate the host's immune response (antigens). Tests
that detect antibodies in the blood are called serology tests,
and they generally indicate either late active infection or
exposure to and recovery from prior infection. Serology
tests are not generally used alone for diagnosis of disease;
rather, they may sometimes be used in combination with a
molecular test for diagnosis. Serology testing also may be
used to identify individuals who can donate convalescent
plasma as a possible therapeutic; to help guide development
of a vaccine; and to determine the extent and spread of
COVID-19 in the general population, as well as the
infection fatality rate. Rapid antigen tests-which have not
yet been authorized for use in the United States for COVID-
19-can detect viral antigens, generally in a throat or nose
swab. These tests are usually point-of-care, low-cost, easy
to use, and used for diagnostic purposes. However, these

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