COVID-19 Testing Supply Chain

COVID-19 Testing Supply Chain

February 25, 2021
COVID-19 Testing Supply Chain
Introduction
specialized equipment and trained personnel, and involve
COVID-19 testing—including for diagnosis, screening, and
numerous steps. Steps include sample collection, storage,
surveillance—is a critical component of responding to the
and transport; sample preparation, including extraction of
COVID-19 pandemic, and its implementation has posed
nucleic acid; and sample analysis and processing. These
numerous challenges. Issues have included those related to
steps are described in further detail below.
Food and Drug Administration (FDA) regulation of tests,
reimbursement and coverage for testing, equitable access to
Point-of-care and nonlaboratory tests are generally less
testing, and infrastructure and supply chain stressors,
complex. While they require fewer steps, they sometimes
among others. In particular, the diagnostic testing supply
rely on specialized equipment for processing, but are often
chain has shown evidence of significant and ongoing stress
able to be read visually. These tests are simpler to
since early in the pandemic, and problems persist with
manufacture and have a less intricate supply chain;
ascertainment, production, and distribution of almost all
however, this type of test was authorized for clinical use by
testing supply chain components.
the FDA later in the pandemic, and so supply chain issues
have manifested more recently. Shortages have included
COVID-19 tests include molecular (e.g., polymerase chain
foam swabs, nitrocellulose paper, and machinery needed to
reaction, PCR), antigen, and serology tests. Molecular and
manufacture the tests.
antigen tests are used for diagnosis, screening, and
surveillance, while serology tests are currently used only
In order to support the manufacturing and procurement of
for surveillance. Tests may be available in different settings
medical countermeasures to COVID-19, the Trump
based on their Emergency Use Authorization (EUA).
Administration developed Operation Warp Speed (OWS),
Specifically, they may require a central laboratory for
an interagency effort involving the Department of Defense
processing; may be available at the point-of-care in a
(DOD), the Department of Health and Human Services
Clinical Laboratory Improvement Amendments (CLIA)-
(HHS), and public-private partnerships between these
regulated environment; or may be nonlaboratory tests, able
agencies and the biomedical industry. Under the Biden
to be carried out in any setting, including the home. Tests
Administration, OWS is being modified and renamed.
with EUA may be commercially manufactured test kits,
Acting through OWS, DOD, and HHS invested to increase
which include all required test reagents in a single unit, or a
the manufacturing of COVID-19 diagnostics and procured
laboratory-developed test (LDT), which are tests developed
diagnostics and ancillary supplies (e.g., pipette tips) for use
by and carried out in specific clinical laboratories. Although
in responding domestically to the pandemic. For example,
commercial test kits and the platforms to run them may be
DOD recently awarded $231.8 million to Ellume to
in short supply, LDTs rely on numerous reagents and
increase production of its at-home over-the-counter test and
components, most of which have been variably in shortage.
procure 8.5 million tests.
Private efforts, spearheaded by the American Society for
Sample Collection
Microbiology (ASM) and the Association for Supply Chain
Individually wrapped, sterile, single-use swabs are the
Management (ASCM), nationally monitor and publicly
preferred tool to collect upper respiratory samples. Some
report on inventory and supply shortages experienced by
tests may allow patients to swab themselves, while others
clinical laboratories. Recent data from these efforts indicate
require a health care professional to perform the sampling.
that clinical laboratories are operating at 40% of their
Swabs used specifically for testing are FDA-regulated
capacity, that key supply shortages continue (e.g., test kits,
products constructed with a flexible stem and a bud made of
consumables), and that supplies for non-COVID-19 testing
synthetic materials that do not contaminate or interact with
are being affected. The Biden Administration’s “National
the patient sample. These are not substitutable with other
Strategy for the COVID-19 Response and Pandemic
cotton swabs or buds. Reports of swab shortages have been
Preparedness” notes that in an end-to-end manner the
ongoing throughout the pandemic, representing a limiting
“federal government will identify, inventory, and monitor
factor in achieving adequate levels of testing nationwide.
the need, availability, and manufacturing capacity of critical
supplies,” including for testing and Personal Protective
Sample Storage and Transport
Equipment (PPE).
Swab samples must be placed in a preserving chemical
solution while in transport to a lab for analysis. Point-of-
Testing Supply Chain
care and nonlaboratory tests, in which evaluation of the
To date, testing supply chain issues have largely arisen with
sample is conducted almost immediately after it is taken, do
molecular tests and specifically real-time RT (reverse
not require sterile transport. The most common preserving
transcriptase)-PCR tests that are carried out in central
transport solution is Viral Transport Medium (VTM), which
laboratories. These tests are highly complex, require
https://crsreports.congress.gov

COVID-19 Testing Supply Chain
maintains the integrity of the respiratory sample and
up the testing process, as skilled personnel to operate the
prevents contamination and degradation.
equipment are also required and may be unavailable.
There are a number of consumables (single-use products)
Ancillary Supplies and Resources
associated with sample storage and transport, as well as
PPE is a critical component of testing. A lack of PPE—
with the subsequent steps of extraction and analysis. These
items such as gowns, masks, gloves, face shields, and
include, for example, the plastic vials (with caps) used to
goggles—and limited visibility into the PPE supply chain
receive and contain samples while in route to a laboratory
have been persistent concerns throughout the pandemic.
for analysis. Delay in production of these consumables or
This has been the result of both materials shortage and lack
general shortages place an additional constraint on
of specialized production equipment. OWS has invested in
nationwide testing capabilities.
increasing manufacturing capabilities in an attempt to
resolve these issues.
Sample Preparation (Nucleic Acid Extraction)
A precursor to sample analysis is sample extraction, in
In addition to material shortages, there have been reports of
which the organic or genetic material is isolated and
personnel shortages. Conducting complex tests requires
prepared for examination and identification. This process
trained personnel capable of operating test machinery. This
involves the use of complex and highly specific reagents
particular supply chain issue is not only the result of a lack
that maintain sample integrity through the isolation process.
of trained individuals with the necessary skill set, but also a
Extraction reagents are available prepackaged and
consequence of the nature of the pandemic, which affects
premeasured in commercial kits. The speed at which these
test kit manufacturers as well as laboratory specialists. A
kits can be produced and used represents a rate-limiting
shortage in trained personnel represents another bottleneck
step in testing. A shortage in a particular reagent may also
in the return of test results.

delay the production of kits in general, regardless of the
supply of other co-packaged materials. In addition, clinical
Another consideration is that testing for other purposes
laboratories carrying out LDTs often make their own
(e.g., sexually transmitted diseases) cannot be put on hold
extraction solutions using the component reagents; this
to devote all resources to COVID-19 testing. Laboratories
ability is affected by the availability of the raw chemicals.
and testing facilities continue to carry out COVID-19 test
Extraction may be performed on individual samples or on
analysis simultaneously with other testing.
multiple samples at once using high-throughput extraction
instrumentation. This machinery increases the speed at
Recent Federal Activity
which multiple tests can be processed, but a shortage of
The Biden Administration’s COVID-19 national strategy
these complex instruments has meant that such time-saving
highlights efforts to increase testing capacity in both the
extraction is not always available.
long and short term. The strategy identifies several actions
to alleviate infrastructure and supply issues: (1) make a
Sample Processing
commitment toward investment in onshore manufacturing
Sample analysis varies based on which type of test is used.
of tests and test supplies; (2) invest in laboratory capacity;
In general, however, reagents used to test for the presence
(3) exercise legal authorities ( e.g., the Defense Production
of virus or antibodies are highly specific and not
Act (DPA)) to expand manufacturing capacity of tests and
substitutable with other test reagents. Any shortage in
test supplies; and (4) promote predictable and robust federal
reagent thus acts as a limiting factor in the number of tests
purchasing of test supplies. Executive Order “A Sustainable
that can be performed. Materials of note include DNA
Public Health Supply Chain” directs agencies to fill supply
primers and probes used in real-time RT-PCR tests.
shortfalls “using all available legal authorities,” including
Commercial kits also exist to test patient samples. These
shortfalls for supplies such as test reagents, pipette tips,
prepackaged, premeasured kits are generally separate from
high absorbency foam swabs, nitrocellulose material for
extraction kits, and instead contain all the reagents
rapid antigen tests, and rapid test kits. Certain DPA-based
necessary to perform sample analysis. The speed at which
action has been announced with respect to rapid at-home
these kits can be produced, and potential shortages of
and point-of-care COVID-19 tests. In addition, the Biden
reagents, represent limiting steps in test kit manufacturing.
Administration announced it will invest $815 million in the
domestic manufacturing of test supplies, including pipette
The machinery used to perform sample analysis may also
tips and nitrocellulose paper for rapid antigen tests.
be highly complex, and can be very costly to procure and
operate. Acquisition of these instruments may thus
Congress may consider retrospectively evaluating testing
represent a limiting factor in the number of tests a
supply chain issues that have occurred during the COVID-
laboratory can analyze at once. In addition, the speed at
19 pandemic to help identify key issues, challenges, and
which the analytic machinery operates is relatively
possible best practices moving forward. Congress may
inflexible, representing a fixed delay in providing test
additionally consider actions aimed at further improving
results. Further, testing platforms are not always
supply chain visibility so any potential shortage may be
interoperable; that is, specific platforms are able only to run
addressed at the earliest junction possible.
specific tests, and the FDA EUA process, which designates
the components that must be used with a particular EUA
Amanda K. Sarata, Specialist in Health Policy
authorized test, further restricts interchangeability.
Simi V. Siddalingaiah, Analyst in Health Economics
Increasing the number of machines may not always speed
IF11774
https://crsreports.congress.gov

COVID-19 Testing Supply Chain

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to
congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress.
Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has
been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the
United States Government, are not subject to copyright protection in the United States. Any CRS Report may be
reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include
copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you
wish to copy or otherwise use copyrighted material.

https://crsreports.congress.gov | IF11774 · VERSION 1 · NEW