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.
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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).
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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)
