INTENDED USE

The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma 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.¹ Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with tropomyosin, this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle.² 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.³ 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.⁴ Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction.⁵

The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of anti cTnI antibody coated particles and capture reagent to selectively detect cTnI in whole blood, serum or plasma. The minimum detection level is 0.5 ng/mL.

KIT COMPONENTS

The test device contains anti cTnI antibody coated particles and capture reagent coated on the membrane.

Materials Provided

1.Test devices

a.Droppers

b.Buffer

2.Package insert

PROCEDURE

Allow test device, specimen, buffer and/or controls to reach room temperature (15~30°C) prior to testing.

1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

2.Place the test device on a clean and level surface.

FOr Serum or Plasma specimens:

HoLd the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 mL) to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.

For Venipuncture Whole Blood specimens:

Hold the dropper vertically and transfer 2 drops of venipuncture whole blood (approximately 50 mL) to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.

For Fingerstick Whole Blood specimens:

• To use a capillary tube: Fill the capillary tube and transfer approximately 50 mL of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.
• To use hanging drops: Allow 2 hanging drops of fingerstick whole blood specimen (approximately 50 mL) to fall into the center of the specimen well (S) on the test device, then add 1 drop of buffer and start the timer.

3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Myoglobin present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.