Accurate Troponin I diagnostic test - INC-420

Accurate Troponin I diagnostic test

NTENDED USE

ONE STEP TROPONIN I TEST IS AN IMMUNOCHROMATOGRAPHY BASED ONE STEP IN VITRO TEST. IT IS DESIGNED FOR QUALITATIVE DETERMINATION OF CARDIAC TROPONIN I (CTNL) IN HUMAN WHOLE BLOOD, SERUM OR PLASMA AS AN AID IN THE DIAGNOSIS OF MYOCARDIAL INFARCTION.

STORAGE AND STABILITY

1. Store as packaged in the sealed pouch at 2-30°C

2. The test device must remain in the sealed pouch until use.

3. DO NOT FREEZE.

4. Do not use beyond the expiration date.

SPECIMEN COLLECTION

1. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C.

2. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

ASSAY PROCEDURE

1. Read package insert carefully before testing. Allow the test devices, whole blood, serum or plasma to equilibrate to room temperature (15-30°C) prior to testing. Do not open pouches until ready to perform the assay.

2. Remove the test device from the foil pouch and use it as soon as possible.

3. Place the test device on a clean and level surface. Hold the dropper provided vertically and transfer 3 drops of specimen (100µl) to the specimen well (S) in the test device.

4. Wait for the red line(s) to appear. The result should be read between 10 to 15 minutes.

INTERPRETATION OF RESULTS

1. Positive

Two colored lines should be observed in the viewing window. The line in the test region (T) is the probe line; the line in the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test line may be weaker or stronger than that of the control line.

2. Negative

The control line appears in the test window, but the test line is not visible.

3. Invalid No line appears in the control region. Under no circumstances should a positive sample be identified until the control line forms in the viewing area. If the control line does not form, the test result is inconclusive and the assay should be repeated.

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