Medical Manufacturing & Outsourcing - Version A. April 2021 - 15

Diagnosing COVID-19:
ANATOMY OF AN LFI TEST DEVICE

E

million individuals, can be tested daily.1
How will the country close this gap?
Multiple COVID-19 test types will
contribute to the increased capacity.
As of this writing, the U.S. Food
and Drug Administration (FDA) had
issued Emer-gency Use Authorizations
(EUA) for well over 100 molecular
tests, two antigen tests, and almost
40 antibody tests. Below is a brief
explanation of the test types.
Diagnostic Tests. Within this
test category, there are two
primary types of tests including:
*M
 olecular tests. The most common
mo-lec-ular test is the reverse
transcription--polymerase chain
reaction (RT-PCR) test, which
detects the COVID-19 virus' genetic
material. The sample is a nasal
or throat swab. This test requires
processing in a specialized laboratory,
and it usually takes a few hours
to one week to obtain results,
although some testing locations
can offer same-day turnaround.2
* Antigen tests. This type of test is
de-signed to recognize proteins on
the surface of the virus.2 The sample
COVID-19 Testing Overview
is a nasal or throat swab. Antigen
As of July 2020, the COVID-19
tests can be administered and read
diagnostic testing capacity in the
close to the point of care (POC),
United States was estimated at
which is why they are also called
between 520,000 and 823,000 tests
rapid diagnostic tests. Results are
daily. One U.S. government initiative
available within 15-30 minutes.
aims to expand testing capacity so
Antibody Tests. Also known as
that by December 2020, approximately
serology tests, these tests identify
2 percent of the U.S. population, or 6
antibodies that the
body's immune
system has generated
in response to
COVID-19 infection. A
Sample Pad Conjugated Pad
Membrane
Absorbent Pad
sample of the patient's
blood is typically
taken through a
finger stick or blood
Backing
Test Line
Control Line
draw. Results can
be provided sameday or within one
to three days. These
tests show whether
Figure 1 - This is a diagram of a lateral flow immunoassay (LFI) test
a person has been
device, similar to one that might be used to diagnose COVID-19. The
infected in the past
device contains layers of flexible materials treated with specialized
chemistries. (Credit: Web Industries Inc.)
but cannot diagnose
very minute matters when an
individual needs to know
whe-ther he or she has con-
tract-ed COVID-19. Beyond
social distancing and masks, COVID-19
testing solutions have an important
role in preventing virus spread. By
offering some certainty about the
presence or absence of infection,
diagnostic testing helps public
health efforts to control the virus.
But at what levels will tests be
needed? How can the medical
device industry scale up test
manufacturing capacity and ensure
a stable supply to the U.S. market?
With their rapid diagnostic
capabilities, lateral flow immunoassay
(LFI) antigen tests are among the
technologies that healthcare providers
and public health organizations are
adding to their testing inventories.
Following is a discussion of these
LFI diagnostic devices and the
manufacturing operations needed to
produce them in large volumes. But
first, a look at the broader picture.

MEDICAL MANUFACTURING AND OUTSOURCING SPECIAL REPORT

an active COVID-19 infection. It
takes the body several days to
weeks to build up antibodies.2

Paths to Scale Production

Regardless of the test type, many of
the same scalability considerations will
apply as the U.S. medical device industry
expands its domestic manufacturing
infrastructure. There are several paths to
secure the needed additional production
capacity. A device original equipment
manufacturer (OEM) might choose to
expand its operations or build a new
manufacturing facility. Some may expand
through acquisition. Others will look to
partner with contract manufacturing
organizations (CMOs) to accelerate test
production, especially for the U.S. market.
By working with contract manu-
facturing partners, OEMs can avoid timeintensive and costly expenditures re-
quired to build their own manufacturing
operations. Starting up a greenfield
diagnostic test manufacturing facility
would take at least one year, especially
when hiring and training are factored
into the timetable. By comparison, a
CMO with market experience often
can get a new product into production
within a matter of months. Even if a
CMO needs to bring a new production
line up, this can usually be accomplished
in six to nine months or sooner if the
necessary equipment is readily available.

Inside a COVID-19 Antigen
Test Kit

While there can be different
configurations, a COVID-19 antigen
test kit typically includes these
items and functions as follows:
* The LFI test strip, usually housed in
a plastic cartridge (see Figure 1)
* Sample collection swab
* A tube filled with an
extraction reagent fluid
* A dropper (if one is not
integrated into test tube)
The healthcare provider inserts the
sample into the tube to mix it with the
reagent solution. Then fluid from the
tube is dispensed via a dropper into
a designated well on the test device.
APRIL 2021 15



Medical Manufacturing & Outsourcing - Version A. April 2021

Table of Contents for the Digital Edition of Medical Manufacturing & Outsourcing - Version A. April 2021

Medical Manufacturing & Outsourcing - Version A. April 2021 - Cov1
Medical Manufacturing & Outsourcing - Version A. April 2021 - Cov2
Medical Manufacturing & Outsourcing - Version A. April 2021 - 1
Medical Manufacturing & Outsourcing - Version A. April 2021 - 2
Medical Manufacturing & Outsourcing - Version A. April 2021 - 3
Medical Manufacturing & Outsourcing - Version A. April 2021 - 4
Medical Manufacturing & Outsourcing - Version A. April 2021 - 5
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Medical Manufacturing & Outsourcing - Version A. April 2021 - 7
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