15 Mins Troponin I Rapid Test Kit For Cardiac Injury CTnI Fast Check Cassette

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.Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C.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. Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.

MAIN CONTENTS

• Rapid test cassette with desiccant
• Disposable pipettes
• Buffer
• Package insert

DETAILED PHOTO

DIRECTION OF USE

Bring tests, specimens, buffer, and/or controls to room temperature (15-30°C) before used.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 2 drops of serum or plasma to the specimen well of the device with the provided disposable pipette, and then start the timer.
OR
Transfer 1 drop of whole blood specimen to the specimen well of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
OR
Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the device, then add 1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate acrossthe membrane.
3. Wait for the colored band(s) to appear. The result should be read within 10 to 15 minutes. Do not interpret the result after 20 minutes.

♦ RESULT READING

POSITIVE:The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE: : The presence of only control line (C) within the result window indicates

INVALID: The control line (C) is not visible within the result window after performing the test.

QUALITY CONTROL

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.