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Immunoassay Platform for Cardiac Marker Test
(Under Development)
 

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.

 

   ►   Cardiac Markers Testing Requirements

 

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.

 

   ►   MCL Technology Features

 

Greater Potential Sensitivity with Chemiluminescence Format

·       Provides access to ultra sensitive assays

·       Provides potential to run assays faster (10-25 min.)

·     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. 

·        Multiple-step bio-processes

·        The MCL Microfluidic platform offers versatility for a variety of applications in a single disc format.

·        Provides doctors and patients immediate access to high-value clinical data.

 

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