INTENDED USE

The Troponin I (cTnI) Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of cardiac Troponin I in human whole blood, serum or plasma specimens. It is intended for use as an aid in the diagnosis of myocardial infarction (MI).

INTRODUCTION

Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa. After cardiac injury occurs, Troponin I is released into the blood 4 - 6 hours after the onset of pain. The release pattern of cTnI is similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 6 - 10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery.

MAIN CONTENTS

Test Cassette

Disposable Pipettes

Buffer

Instructions for use

STORAGE AND STABILITY

Store at 2 ~ 30 º C in the sealed pouch for 24 months.

Keep away from direct sunlight, moisture and heat.

Do not freeze.

TEST PROCEDURE
1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 3 drops of the specimen (approximately 75 µL) to each specimen well (S) of the device, then add one drop of buffer and start the timer.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

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