IVD
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Scope of Application

 

· Selective angiography

· Deliver embolic agents (such as embolic coil) and vascular stents into artery vessels.

· The Emergency Department , the Laboratory Department , the Internal Cardiology

· Department, the Department of Cadiac Surgery , the community medical institution, and on-site emergency treatment.

· Clinical symptom : Chest pain, sense of suppression in the chest, difficulty in breathing etc.

· Blood samples: Venous blood (whole blood, serum, plasma) or fingertip blood.

· Easy to store : at 4 to 30o C for a period of 24 months 

 

 





Features

Fast

Adopt the Colloid gold immunochromatography, only requires 15 minutes for the whole test process.

Convenient

Only need 2-3 drops of blood samples, no need for additional equipment and explanation.

Accurate
High stability , accuracy is more than 98%

 

 





Markers 

 

Biomarker of myocardial damage 




Heart-type Fatty Acid Binding Protein (h-FABP) 

Cardiac Troponin I (cTnI) Combination Test

Best Combination Test for Diagnosis and Prognosis of Acute Coronary Syndrome (ACS) and Acute Myocardial Infarction (AMI) 



Combination test vs. single parameter test

· h-FABP released to the circulation fast. Early diagnosis, early treatment

· cTnI as the ‘Gold Standard’ of AMI, assuring the accuracy of diagnosis

· h-FABP has high sensitivity and high specificity as the biomarker of early MI

· Combination test widens the diagnostic time window to as early as 2 hours after the MI

· Combination test have higher diagnostic value than single parameter test




Cardiac Troponin I (cTnI) 
Myoglobin (Myo) 
Creatine Kinase MB (CK-MB) Combination Test

Most common combination test for diagnosis of Acute Coronary Syndrome (ACS) and Acute Myocardial Infarction (AMI) 


· Early diagnosis for AMI

· Early diagnosis and risk assessment for ACS

· Monitor the myocardial surgery injury

· Identify the cause of thoracodynia

· Myoglobin and CK-MB can be eliminated by kidney rapidly. Therefore, monitoring these parameters can foresee the relapse or development of MI

 
Combination test vs. single parameter test

· Cover a wide diagnostic time window 

· Lessen missed diagnosis and misdiagnosis 

· High positive forecast value 

· Improve the accuracy of diagnosis



Biomarker of myocardial failure



Marker forecasting heart disease



 





 





Parameters

 

Biomarker

Corresponding symptom

Detection range

Diagnostic threshold

h-FABP

Myocardial infarction

2.5-50ng/mL

7.0ng/mL

cTnI

Myocardial infarction

0.1-25ng/mL

0.5ng/mL

NT-proBNP

Heart failure

100-10000pg/mL

cTnI: 0.1-25ng/mL

Low:300pg/mL

High:1800pg/ mL

cTnI/ h-FABP

Myocardial infarction

cTnI: 0.1-25ng/mL

h-FABP: 2.5-50ng/mL

cTnI: 0.5ng/mL

h-FABP: 7.0ng/mL

cTnI/ Myo/CK-MB

Myocardial infarction

Myo:25-500 ng/mL

CK-MB:2.5-50ng/ mL

cTnI: 0.5ng/mL

Myo:50 ng/mL

CK-MB:5.0ng/ mL

D-Dimer

Myocarditis

200-5000ng/mL

500ng/mL

Hs-CRP

Myocarditis

0.5-50ug/ml

1ug/ml

PCT

Myocarditis

2.5-25ng/mL

0.5ng/mL

[1] Alhadi HA etal. Q J Med. 97(2004):187-98

[2] R.Body et al. Resuscitation 82(2011):1041-1046

[3] Common understanding on clinical use of NT-proBNP by Chinese experts(2011)

[4] Baldus S et al. Circulation 2003;108:1440-1445

 

 





Ordering Information
 


·  cTnI one step test cassette
·  h-FABP one step test cassette
·  D-Dimer one step test cassette
·  NT-proBNP one step test cassette
·  hs-CRP one step test cassette
·  PCT quantitative cassette
·  cTnI/h-FABP one step test cassette
·  cTnI/Myo/CK-MB one step test cassette




 





Contact Us



If you have any query about the product information, please contact our International Sales & Marketing Department: international@lepumedical.com

 

SOURCE: Lepu Medical International Sales & Marketing Department



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