Medical Design Briefs - June 2021 - 14

NEXT GEN
POC Diagnostics:
Electronic Measurement
Technology Driven
by Global Demand
for COVID-19 Testing
he in-vitro diagnostic (IVD)
home point-of-care (POC)
product landscape will look
very different over the coming
years as new products to detect
the COVID-19 virus are launched. It is
driven in part by FDA's Emergency Use
Authorization (EUA), which fast-tracks
the traditional 510(k) process so that
COVID testing can be as ubiquitous as
measuring your temperature.
And $157 million has already been distributed
by the Biomedical Advanced
Research Development Agency (BARDA)
to support the development of more than
40 COVID-19 diagnostic products. Some
of those products are targeted for POC
use cases versus laboratory testing. Many
new companies entering the market are
planning a diagnostic roadmap of capabilities
beyond their entry point of
COVID-19 testing.
T
IVD and POC Defined
" In vitro diagnostic products are those
reagents, instruments, and systems
intended for use in the diagnosis of disease
or other conditions, including a
determination of the state of health, in
order to cure, mitigate, treat, or prevent
disease or its sequelae. Such products
are intended for use in the collection,
preparation, and examination of speci14
Cov
mens
taken from the human body " compared
with in-vivo products, which perform
the same but within the human
body as defined by the FDA. According
to FDA, " POC testing means that results
are delivered to patients in the patient
care settings, like hospitals, urgent care
centers, and emergency rooms, instead
of samples being sent to a laboratory. "
Optical vs. Electrochemical Test
Techniques
IVD POC products available today like
glucose meters or pregnancy test kits will
soon share " shelf space " with start-ups
offering novel sensors and meters using
nasal swabs, saliva, urine, sweat, and
blood. These new IVD products will use
the latest in sensor technologies, ultra
low power analog, precision mixedsignal,
and digital processing, and they
will be highly portable, including using
biocompatible enclosures for wearable
applications. They will also harness the
enormous computing power of smartphones
and the cloud.
The two basic measurement techniques
for IVD POC home testing are optical and
electrochemical (EC). Pregnancy test kits,
for example, detect human chorionic
gonadotropin (hCG) in urine. Urine is
placed on the end of the nitrocellulose
strip and flows; hCG binds with dyed
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ToC
mobile antibodies and is captured using
fixed antibodies to produce a color line
that LEDs and photodiodes will detect.
Glucose test strips require a very small
drop of blood at the tip of the strip where
the chemical enzymes are stored.
An electrical connection is made from
the meter to the test zone on the strip to
allow a voltage stimulus and measurement,
whereas a system using nitrocellulose
strips only requires a simple me -
chanical interface like a light pipe to
focus the LED signal on the strip and
capture the reflected signal on the photodiode.
This article focuses on the
more widely used POC electrochemical
measurement technique. Future articles
will address optical techniques.
EC Measurement Background
In every household, two-terminal batteries
are the most common example of
a dc power supply. They are used for
flashlights, mobile phones, clocks, etc. A
well-known EC application is the electrolysis
of compounds. A common in -
dustrial example is the chlor-alkali
process where the salt (NaCl) and water
(H2O) in saltwater are split into chlorine
(Cl2), hydrogen (H2), and sodium hy -
droxide (NaOH).
The disadvantage of two-terminal EC
applications is that it is not possible to
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Medical Design Briefs - June 2021

Table of Contents for the Digital Edition of Medical Design Briefs - June 2021

Medical Design Briefs - June 2021 - Intro
Medical Design Briefs - June 2021 - Cov4
Medical Design Briefs - June 2021 - Cov1a
Medical Design Briefs - June 2021 - Cov1b
Medical Design Briefs - June 2021 - Cov1
Medical Design Briefs - June 2021 - Cov2
Medical Design Briefs - June 2021 - 1
Medical Design Briefs - June 2021 - 2
Medical Design Briefs - June 2021 - 3
Medical Design Briefs - June 2021 - 4
Medical Design Briefs - June 2021 - 5
Medical Design Briefs - June 2021 - 6
Medical Design Briefs - June 2021 - 7
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Medical Design Briefs - June 2021 - 13
Medical Design Briefs - June 2021 - 14
Medical Design Briefs - June 2021 - 15
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Medical Design Briefs - June 2021 - Cov3
Medical Design Briefs - June 2021 - CovIV
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