Multiple Cardiac Marker (8 in 1) Kit

Intended use

This device is intended to be used for the in vitro quantitative determination of 8 items in human whole blood or plasma related to the heart and lungs, including high sensitive cardiac troponin I (hs-cTnI), myoglobin (MYO), creatine kinase isoenzyme (CK-MB), d-dimer (D-Dimer), N-terminal proBNP (NT-proBNP), B-type natriuretic protein (BNP), myeloperoxidase (MPO), heart-type fatty acid-binding protein (H-FABP). 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. This kit adopts a highly sensitive method to measure cTnI, namely high sensitive cardiac troponin I (hs-cTnI), which can detect the increase of cTnI in the blood at the early stage of myocardial injury (1-2 hours), and can detect cTnI in more than 50% of healthy population samples, and the coefficient of variation of the 99th percentile value is ≤10%.

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 alsoSummary

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. This kit adopts a highly sensitive method to measure cTnI, namely high sensitive cardiac troponin I (hs-cTnI), which can detect the increase of cTnI in the blood at the early stage of myocardial injury (1-2 hours), and can detect cTnI in more than 50% of healthy population samples, and the coefficient of variation of the 99th percentile value is ≤10%.

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.

D-dimer is a specific degradation product produced by plasmin hydrolysis after fibrin monomer is cross-linked by activating factor XIII, which can reflect the coagulation function and fibrinolytic activity in the body. It is an indicator of the body's hypercoagulable state, thrombosis, and secondary hyperfibrinolysis. The level of D-dimer is increased during deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, severe hepatitis and other diseases, and after thrombolytic therapy, which can be used as an effective observation indicator for thrombolytic therapy. Due to its extremely high sensitivity and negative predictive value, D-dimer negativity has been clinically used as an important basis for excluding pulmonary embolism (PE) and deep venous thrombosis (DVT). A variety of clinical diseases can cause increased D-dimer concentration. Non-disease states such as long-distance travel or sedentary conditions can also increase the concentration of D-dimer in the body.

N-terminal proBNP (NT-proBNP) and B-type natriuretic protein (BNP) are obtained by cleavage of proBNP. The 134-amino acid pre-proBNP produced after stimulation of cardiomyocytes is further converted into a 108-amino acid proBNP. The latter is cleaved under the action of endoproteinase into N-terminal proBNP (NT-proBNP) containing 76 amino acids, which is biologically inactive, and B-type natriuretic peptide (BNP) containing 32 amino acids, which is active. NT-proBNP and BNP are mainly synthesized by left ventricular cardiomyocytes and secreted into the blood. Therefore, NT-proBNP and BNP, as effective markers of heart failure, can independently predict the increased ventricular pressure. They are of great value in the auxiliary diagnosis, treatment evaluation and monitoring for congestive heart failure, dyspnea complications caused by congestive heart failure, the essential hypertension, left ventricular dysfunction and other cardiovascular-related diseases.

Myeloperoxidase (MPO) mainly exists in the azurophilic granules of neutrophils or monocytes. During inflammation, neutrophils degranulate and release MPO. It can lead to instability or even rupture of coronary atherosclerotic lesions, to make exposure of subendothelial collagen tissue, followed by platelet adhesion and aggregation and thrombosis, resulting in acute coronary syndrome (ACS) and severe myocardial irreversible ischemic damage. The pathogenic mechanism of MPO includes oxidizing low-density lipoprotein, enhancing the pathogenic effect of low-density lipoprotein, accelerating the formation of atherosclerotic plaques; generating free radicals and various reactive substances to promote coronary atherosclerotic plaques instability and rupture; oxidizing high-density lipoprotein to make apolipoprotein A1 lose the function of reverse cholesterol transport, resulting in intracellular deposition of cholesterol; promoting the formation of atherosclerotic plaques and plaque instability, causing ACS . A large number of clinical studies have shown that the changes of MPO levels are closely related to the onset of acute myocardial infarction (AMI), and serum MPO levels in ACS patients are significantly increased, so MPO can be used as a new predictor of cardiovascular adverse events in ACS patients, especially in the presence of low troponin levels, MPO is able to identify those high-risk patients who will develop MACE.

Heart type-fatty acid binding protein (H-FABP) is a novel small cytoplasmic protein abundant in the heart. It is mainly expressed in cardiac tissue with high cardiac specificity. H-FABP can be found in the blood 0.5~3h after myocardial ischemic injury, peak at 6~8h, and return to normal within 24~30h. The early diagnostic significance of H-FABP for myocardial injury is mainly based on its following characteristics: a. high concentration in the myocardium; b. low molecular weight; c. relative tissue specificity; d. its distribution is similar to that of CK-MB in tissues other than the heart; (5) is rapidly released into plasma following myocardial injury. Compared with myoglobin (MYO), the concentration of H-FABP in the heart is 2-10 times higher than that in skeletal muscle, while the concentration of MYO in cardiac cells is 1/2 that of skeletal muscle, although elevated plasma MYO levels are now widely accepted. an early marker of myocardial injury, but HFABP is more cardiac-specific. Clinical studies have shown that H-FABP in the cytoplasm is rapidly released into the blood at the very early stage of the onset of AMI, so H-FABP can be used as a marker for early diagnosis of AMI.

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.

Ischemic heart disease (ACS), fatal non-myocardial ischemia (AAD, PE) and other diseases are the main causes of acute and fatal chest pain. Reasonable combined detection of cardiac troponin I (cTnI), myoglobin (MYO), creatine kinase isoenzyme (CK-MB), D-dimer, N-terminal proBNP (NT-ProBNP) can provide a better objective basis for the diagnosis and treatment of patients with acute chest pain.

Recent studies have found that MPO and H-FABP are closely related to coronary inflammation and the pathogenesis of AMI, and these two indicators can be used as biomarkers for early warning and diagnosis of AMI. As a biomarker of atherosclerotic vulnerable plaque, MPO is associated with the diagnosis of ACS and patient prognosis, and can predict the risk of major adverse cardiac events (MACE) in the absence of myocardial necrosis. H-FABP is a cardiac marker reflecting myocardial cell injury, with strong cardiac specificity, which can be used for early warning and diagnosis of AMI within 1-3 hours of AMI. Cardiac troponin I (cTnI) exists in cardiomyocytes in different forms. After myocardial injury, cTnI in peripheral blood generally increases at 5-8 hours, reaches the highest value at 12-24 hours, and can be maintained at a high level for 7-20 days. It can be seen that compared with the detection of cardiac troponin alone, the combined detection of MPO, H-FABP and cTnI can be used for monitoring the first stage of AMI (vulnerable plaque), the early stage of AMI and the entire AMI process, which is helpful to avoid missed diagnosis events before the onset of AMI and in the early stage of AMI due to no obvious changes in ECG and undetectable cardiac troponin (cTn). It can also be used to assess the risk of MACE after thrombolytic therapy for AMI or PCI, and to determine the risk of MACE in cTn-negative ACS patients.

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

APPLICATION SCENARIOS

Hospitals

Laboratory

Clinics

Ambulance

Cardiology

Pediatrics

Emergency

CSC

FAQ

Q: Is it possible to OEM?

A: Yes. Clients need to authorize brands and provide design solutions.

Q: How long is the usual delivery time?

A: The regular delivery time is about 2 weeks. If you need to do new packaging (OEM), the delivery time for the first order is 25-30 days, and the second order starts and the regular delivery time is the same.

Q: Are there any requirements for reagent storage? 

A: The storage temperature of our reagents is room temperature, 2-30℃

Q: Reagent expiration date?

A: 12 months.

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