Field Serum Cardiac Protein Study in San Diego???

rev.01-22-98

Why???

"Chest Pain management!"

Because every minute is a measure of myocardium.

Why? As an aid in determining an A.M.I. in a patient with "chest discomfort" of suspecting cardiac origin or a suspicion of a cardiac patient with atypical symptoms. A qualitative determining test for positive CK-MB and myoglobin in whole blood as an aid in the diagnosing of myocardial infarction can be accomplished in less than 20 minutes. Just as with the 12 Lead E.C.G. studies, a serial Serum study should be preformed. The test can detect A.M.I. and also confirm reperfusion.

This program is being done at various South Florida Cities by paramedic providers to include Pompano Beach, Boynton Beach, Margate, Hollywood and Pembroke Pines Florida as well as other cities in the U.S. The preliminary data comming out of the initial phase of the programs are promissing and has proven to be effective in evaluating true Acute Myocardial Infarct patients.

Kinetics

Serum Enzyme Marker studies are sophisticated and studies can reveal Myoglobin increases one hour after the onset of an A.M.I. The Myoglobin test is very sensitive but not specific. Myoglobin is an oxygen binding heme protein normally found in both cardiac and skelital muscle. Cell injury durring acute cardiac infarction (AMI) has been shown to release myoglobin into the blood. The time needed for myglobin to reach the upper limit of normal is approximately 2-3 hours after onset of symptoms. Maximum concentrations are generally recorded after 9-12 hours.

Another cytoplasmic protein, creatine kinase (ATP:creatine N-phosphotransferase, E.C. No. 2.7.3.2.) (CK), also has a significant role in the diagnosis of AMI. CK catalyzes the reversable phosphorylation reaction of creatine with ATP. In humans, isoenzymes of CK have been identified in both the cytosol and mitochondria of cells for a variety of tissue. Cytosolic CK exist as a dimeric molecule formed from twp types of single-polypeptide subunits, designated "M" and "B." These two subunits combine to form three different isoenzymes of CK: CK-MM, CK-BB, CK-MB. CK-MM isoenyme is predomininately found in skeletal muscle. While the CK-MB isoenzymes is most predominent in cardiac muscle tissue. The time required for blood CK-MB levels reach a level that indicates an infarct appears at 4-5 hours after onset of symptoms with maximum concentrations being reached after 12-24 hours. CK-MB levels generally return to normal within 72 hours.

The troponin compex is formed of three subunits, troponin T (TnT), troponin C (TnC) and troponin I (TnI). Different isoforms of TnI exist in skeletal muscle and cardiac muscle (sTnI and cTnI). Detection of cTni in the serum was reported by several clinical reports that have demontrated the diagnostic value of determing the serum level of cTnI in identifying patients with AMI. Temporal relation of release of cTnI into the serum has been investigated and compared to the other established cardiac markers such as CK-MB, myoglobin. Cumulative data from several reports documented that in patients with AMI, cTnI is released into the circulation with levels exceding the upper reference limit of normal 4-6 hours after onset of symptoms and peaked levels are reached after 12-24 hours. Levels of Troponin I remain elevated for 5-7 days.

With this data and serial studies, a detailed time frame of the cardiac event can be obtained with the onset of symptoms as a guage. This data with 12 lead E.C.G serial records can accurately diagnose an AMI.

Myoglobin is more sensative but not as specific. Enzime levels increase quicker than Troponin I.

However, Troponin I is more specific. Troponin is a definative marker at six hours form onset of symptoms.

The Equipment:

The Spectral Cardiac STATus CK-MB/Myoglobin and Troponin I Test Kits provide a preliminary analytical and simultaneous cardiac marker test result at "the point of care" (at scene or en-route). These unit are disposable and about the size of a credit card. It is a rapid , in vitro diagnostic kit for the simultaneous, qualitive determination of CK-MB and myoglobin and Troponin I in human whole blood as an aid in the diagnosis of acute myocardial infarction.

In mid 1998, a new triple kit will be introduced for consumers to use that will evaluate all three enzimes in one kit. This should make the test not only easier but it will save time.

The procedure: (summary)

Place seven drops of whole blood from a venous draw in the sample area. Blood is then filtered through a patented separation/collection membrane assembly. Plasma with cardiac proteins is isolated within 3 minutes. Place four drops of the developer into the sample area and wait 15 minutes. The developer initiates the plasma migration through the pad impregnation with dye-linked antibodies. Antibodies specifically bind to each of the cardiac proteins (CK-MB/Myoglobin) forming antibody/protein complexes. Antibody protein complexes bind to matching immobilized antibodies on the test strip

.a) CK-MB

b) Myoglobin

c) Control

"This bonding forms pinkish-purple, horizontal bands visible through the results windows indicating a positive test result." A visible control band verifies that the test procedure has been preformed accurately.

The test for troponin I is similar.

In Conclusion:

Afterwards, when at the E.D. and the initial field 12 Lead E.C.G. study, a serial E.C.G. is preformed by cardiology, "laboratory blood work" has been preformed by a Lab Technician, and the entire clinical picture, including patient history applied with professional judgement, an informed and accurate diagnosis can be made.

Can it happen??? Yes!!!

Will it happen???

Stand by for further...

For product information:

Contact Spectral Diagnostics INC.® Tm

The Spectral Cardiac STATus CK-MB / Myoglobin and Troponoin I Test Kits provides preliminary analytical test results; a quantitative alternative method must be used in order to obtain a confirmed analytical results. The entire clinical picture, including patient hystory, ECG, and professional judgement should be applied when assessing any cardiac marker test results.

This kit should be used by professional health care professionals under the guidance of a physicain.

Spectral Cardiac STATus® is a registered trademark of Spectral Diagnostic Inc. ©Copyright 1995. All rights reserved.

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