Cardiac Maker Rapid Test
ALLTEST Cardiac Troponin I Rapid Test Cassette
MDA Reg No.: IVDC6364820-42427
Alltest cTNI is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human whole blood, serum or plasma at a level equal to or greater than 0.5 ng/mL.
Any use or interpretation of this preliminary test result must also rely on patient's symptoms and the professional judgement of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device.
Accuracy : 99.1%
Sensitivity : 97.6%
Specificity : 99.4%
Detection : => 0.5ng/mL
ALLTEST Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette
MDA Reg No.: IVDC660020-42428
The Myoglobin/CK-MB/Troponin I Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin, CK-MB and cardiac Troponin I (cTnI) in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Any use or interpretation of this preliminary test result must also rely on patient's symptoms and the professional judgement of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device.
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Sensitivity: 99.4%(Cardiac Troponin I) / >99.9%(Myoglobin) / >99.9%(CK-MB)
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Specificity: 99.0%(Cardiac Troponin I) / 97.2%(Myoglobin) / 99.4%(CK-MB)
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Accuracy: 99.1%(Cardiac Troponin I) / 97.5%(Myoglobin) / 99.4%(CK-MB)
