The MCL Bio-Disc technology is a
miniaturized, self-contained, microfluidic
cartridge that can rapidly and
simultaneously identify all three cardiac
markers with ultra high sensitivity and
specificity.
The MCL-disc employs the chemiluminescence
method, one of the most sensitive and
established optical detection principles
used in main laboratory immunoassay systems.
MSI's proprietary 3D self-contained
microfluidic Bio-Disc technology automates
the assay process in a small, low-cost
platform.
Time-sensitive,
cardiac critical care testing is
a primary need in today's
medical arena
Heart disease remains the leading cause of
morbidity and mortality in the western
world. In the U.S. alone, about 8 million
patients present to the emergency department
(ED) each year with acute chest pain.
Approximately 2 million patients will be
diagnosed with acute coronary syndromes,
i.e., acute myocardial infarction (AMI) or
unstable angina.
Managing patients with chest pain is one of
the most difficult challenges ED physicians
confront. Most patients are placed in
critical care units for a two-day stay to
rule out an acute myocardial infarction.
However, admission of patients with a low
probability of acute coronary
artery disease can lead to excessive
hospital costs. As a result, there is a
growing demand for products that can provide
rapid, quantitative, and cost effective
diagnostic tests in virtually all patient
care settings including critical and
intensive care units, operating rooms,
emergency rooms, physician’s offices,
clinics, and even at the patient bedside.
MSI’s Immunoassay Platform for Cardiac
Marker Test provides a superior alternative
to current point-of-care diagnostic methods.
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Cardiac
Markers Testing Requirements |
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The cardiac marker
testing arena has
stringent requirements.
1. The American Heart
Association (AHA)
recommends a turn-around
time (TAT) of 60
minutes, but states that
a 30–minute TAT is
preferable. Most
central laboratories
cannot consistently
deliver TATs for cardiac
markers within the
recommended 30- to
60-minute time frame,
even if the laboratory
is connected to the ED
by a pneumatic tube
system. Point-of-care
testing (POCT) for
cardiac markers is a
more realistic option
for timely TATs.
2. Cardiologists
typically trend results
of cardiac markers
beginning with the ED
sample. However, it
is difficult, and in
some cases impossible,
to compare results of
tests performed at the
POC versus the central
laboratory. The
POCT and central
laboratory system use
very different assay
protocols;
standardization between
assays is difficult if
not impossible. To date
there is no single assay
standard for cardiac
markers.
3. New National
Committee on Clinical
Laboratory Standards (NCCLS)
Guidelines for Troponin
assays require
improvement in
analytical sensitivity
(> 99th
percentile) and
precision (< 10% CV).
This will pose a
significant challenge
for current POCT testing
devices. While
membrane or strip-based
POCT immunoassay tests
have proven useful in
obtaining qualitative or
“yes/no” results, they
are not very useful for
making quantitative
measurements. Even using
basic instrument- based
readers, test
sensitivity is limited
and the typical CV is
large.
4. Because the interval
between the onset of
pain and ED presentation
is variable from patient
to patient, two or
three markers are needed
to enable
detection in patients
who present either early
or late. At present,
physicians prefer to
monitor Troponin I,
CK-MB, and Myoglobin
simultaneously. Serial
testing (2 to 3 samples
beginning at patient
presentation and at
intervals of up to 6 to
8 hours) is the standard
for diagnosis of AMI
under international
criteria.
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MCL
Technology Features |
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Greater Potential Sensitivity with
Chemiluminescence Format
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Provides access to ultra sensitive assays
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Provides potential to run assays faster
(10-25 min.)
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Results can be directly correlated with
reference methods and existing main lab
systems
Reagent Disc cartridge
design allows for lower cost instrument
designs to be utilized
· Cost-efficient
- low cost instrument and consumables
· Easy
to use design that requires minimal training
and servicing
Easy and rapid adoption of new chemistries
to system
· Partners
with chemiluminescence business can utilize
existing menu development assets and
personnel to introduce new tests.
Multiplexed assays
·
A
panel of appropriate diseases related tests
can be simultaneously tested on the MCL
platform.
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Multiple-step bio-processes
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The MCL Microfluidic platform offers
versatility for a variety of applications in
a single disc format.
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Provides doctors and patients immediate
access to high-value clinical data.
