Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

This device is intended to be used for the in vitro quantitative determination of Cardiac Troponin I (cTnI), Myoglobin (MYO) and Creatine kinase isoenzyme (CM-MB) in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

Troponin is composed of three subunits of troponin I, T, and C, which together with tropomyosin to regulate the interaction between actin and myosin by regulating the activity of Ca2+ on striated actin ATPase. After myocardial injury, cardiac troponin complexes are released into the blood. After 4 to 6 hours, the increase can be detected in the blood, and the elevated troponin I can remain in the blood for 6 to 10 days, providing longer detection period. Cardiac troponin I (cTnI) has high myocardial specificity and sensitivity, so it has become an ideal marker of myocardial infarction.

Myoglobin (Mb) is a hemoglobin that was first found in striated muscle cells (skeletal and cardiac muscle). Myoglobin binds to oxygen in a reversible form, which can enhance the transport of oxygen in mitochondria and plays an important role in the process of cellular aerobic metabolism. When myocardial cells die (eg, in a myocardial infarction), myoglobin and other proteins are released into the peripheral blood circulation due to damage to the cell membrane and can be detected in the blood. The myoglobin level can rise as early as 2 hours after the onset of chest pain; it also increases due to myocardial damage in patients with severe congestive heart failure and cardiac surgery, blood. Myoglobin is a sensitive indicator for the diagnosis of acute myocardial infarction and one of the markers of myocardial infarction. It is currently recognized as one of the the best early indicator for the diagnosis of acute myocardial infarction (AMI).

Creatine Kinase (CK) is a dimeric enzyme with four isoenzyme forms: muscle type (MM), brain type (BB), hybrid type (MB) and mitochondrial type (MiMi), Among them, MB type mainly exists in cardiomyocytes. During myocardial infarction, creatine kinase increases within 6 hours of onset, peaks within 24 hours, and returns to normal within 3 to 4 days. Among them, creatine kinase isoenzyme MB has a high diagnostic specificity, so CK-MB is the current marker of myocardial infarction. It is of significance to clinical for the diagnosis of acute myocardial infarction. If AMI recurs, CK-MB has been declined will rise again. CK-MB measurement can also be used as a non-invasive assessment of myocardial reperfusion after thrombolytic therapy.

MYO is a good early indicator for the diagnosis of acute myocardial infarction, and cTnI is an indicator with high specificity for the diagnosis of AMI. Although CK-MB is not as early as MYO and not as sensitive as cTnI, it has certain value in the diagnosis of early reinfarction after AMI.

It has been clinically proved that any single test result may be misdiagnosed and missed, and the combined test is more helpful for early and accurate diagnosis of AMI.

The current clinical methods include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® Cardiac Markers
Format	Cassette	Reaction Time	10min
Linearity	cTnI: 50～20000pg/mL MYO: 10～400ng/mL CK-MB:1.5～100ng/mL	Reference Interval	cTnI ≤150pg/mL MYO ≤140ng/mL CK-MB ≤4.9ng/mL
Sample	WB / S / P	Certificate	CE / NMPA

ORDERING
Cat. No.	LMCMCM25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LACMCM25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T