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cTnI Quantitative Test Kit(TRFIA)
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cTnI Test is used as an aid in differential diagnosis of troponin elevation in acute myocardial infarction, severe pulmonary embolism causing acute right heart overload, heart failure, and myocarditis.
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Product Description
产品详细右侧内容:

cTnI Test is used as an aid in differential diagnosis of troponin elevation in acute myocardial infarction, severe pulmonary embolism causing acute right heart overload, heart failure, and myocarditis.

Intended Use

The Cardiac Troponin I (cTnI) Test Kit is suitable for use in vitro with Time-Resolved Fluorescence Immunoanalyzer reader to rapidly quantify the concentration of cTnI in human serum and heparin anticoagulated whole blood or plasma specimens at a point of care site. The test is intended to be used as an aid in diagnosis of acute myocardial infarction (AMI), risk stratification of acute coronary syndrome (ACS), and monitoring of myocardial damage .

 

Product Information

 

Production name

Test samples

Specifications

cTnI Quantitative Test Kit (TRFIA)

serum/plasma/whole blood 

20T/Kit, 50T/Kit

 

Storage Conditions and Expiry Date

The validity of test kit sealed in an aluminum foil pouch is 18 months under condition of 2-8℃. The sealed test kit is stable for up to 30 days under room temperature (2-30℃) within validity period. Temperature change (< 37℃) during shipment has no effect on quality of the test kit. The unsealed kit is stable within 1 hour under ambient condition.

 

Product Performance

Low limit of detection: cTnI:< 0.05 ng/mL

Accuracy: <15%

Measuring range: cTnI:< 0.1-20 ng/mL

Within-batch variation: CV≤15%

Batch-to-batch variation: CV≤15%

Cut-off: cTnI:< 0.2 ng/m

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