Troponin Rapid Test Accuracy

Specimen : WB/S/P Format : Strip/Cassette/Uncut Sheet High accuracy

INTENDED 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.

MATERIALS PROVIDED

 1. Test cards  individually foil pouched with a desiccant 

 2. Plastic dropper

3. Package insert 

 MATERIALS REQUIRED BUT NOT PROVIDED

 1. Timer/clock

 2. Pipette

 3. Controls 

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.

 Accuracy

Cut off	Special
0.5ng/ml	99.9%
0.2ng/ml	97%
0.1ng/ml	93%

Interference testing

The following substances were added to the negative control and 0.5ng/ml Troponin I spiked serum samples. No interference was found with any of the substances at the following concentrations:

substance	concentration
Bilirubin	10 mg/ml
Cholesterol	800 mg/ml
Hemoglobin	250 mg/ml
Triglyceride	250 mg/ml
sTnI	1000ng/ml
cTnT	1000ng/ml
cTnC	1000ng/ml

Troponin Rapid Test Accuracy