Troponin Ⅰ 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.
Troponin Ⅰ SUMMARY
Cardiac Troponin I (cTnI) is a cardiac muscle protein with a molecular weight of 22.5
kilodaltons. Together with troponin T (TnT) and troponin C (TnC),
TnI forms a troponin complex in heart to play a fundamental role in
the transmission of intracellular calcium signal actin-myosin
interaction. Although troponin I is also found in skeletal muscle,
cardiac troponin I (cTnI) has an additional amino acid residues on
its N-terminal which distinguishes it from its skeletal muscle form
making cTnI a specific marker for indicating cardiac infarction.
cTnI is released rapidly into blood stream soon after the onset of
acute myocardial infarction (AMI). Its release pattern is similar
to CK-MB (4-6 hours after the onset of AMI). However, CK-MB level
returns to normal after 36-48 hours, when levels of cTnI remains
elevated for up to 6-10 days. The level of cTnI is below 0.06ng/ml
in average in healthy people, and also not detected in the patients
with skeletal muscle injury. Therefore, cTnI is a specific marker
for diagnosis of AMI patients. The level of cTnI may reach
100-1300ng/ml in some AMI patients.
Troponin Ⅰ PRINCIPLE OF THE ASSAY
The One-Step Troponin I Test is a chromatographic immunoassay for the qualitative
determination of cTnI in human whole blood, serum or plasma. When
specimen is added to sample pad, it moves through the conjugate pad
and mobilizes gold anti-cTnI conjugate that is coated on the
conjugate pad. The mixture moves along the membrane by capillary
action and reacts with anti-cTnI antibody that is coated on the
test region. If cTnI is present, the result is the formation of a
colored band in the test region. If there is no cTnI in the sample
the area will remain colorless. The sample continues to move to the
control area and forms a pink color, indicating the test is working
and the result is valid.
Troponin Ⅰ 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.
Troponin Ⅰ PRECAUTIONS
1. For professional and IN VITRO diagnostic use only.
2. The test device should remain in the sealed pouch until use. Do
not use after the expiration date.
3. All serum or plasma specimens should be considered potentially
hazardous and handled in the same manner as an infectious agent.
4. The test device should be discarded in a proper biohazard
container after testing.
5. Avoid cross-contamination of serum samples by changing a new
specimen pipette for each sample.
Troponin Ⅰ 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.
Troponin Ⅰ MATERIALS PROVIDED
1. Test cards individually foil pouched with a desiccant
2. Plastic dropper
3. Package insert
Troponin Ⅰ MATERIALS REQUIRED BUT NOT PROVIDED
Troponin Ⅰ 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
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
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
LIMITATIONS OF PROCEDURE
1. The test result should be used in conjunction with other
clinical information such as clinical signs/symptoms and other test
results to diagnose AMI. A negative result obtained from a patient
whose sample was taken at 2-16 hours after the onset of chest pain
may help in ruling out AMI.A positive result from a patient
suspected of AMI may be used as a rule-in diagnosis and requires
further confirmation. Serial sampling of patients suspected of AMI
is also recommended due to the delay between the onset of symptoms
and the release of the cTnI into the blood stream.
2. The Troponin I test only provides qualitative result. A
quantitative method must be used to determine the cTnI
3. As with all diagnostic tests, a definitive clinical diagnosis
should not be based on the result of a single test, but should only
be made by the physician after all clinical and laboratory findings
have been evaluated.
The One-Step Troponin I Test designed to yield a positive result
for cTnI concentrations at 0.5 ng/ml or greater. The time required
for blood cTnI level to reach the upper limit of normal has been
found to be 4-6 hours after the onset of symptoms. CTnI level
reaches the maximum concentration after 12-24 hours of the onset,
and then remains elevated for 6-10 days in some cases. Therefore, a
negative result within the first hours of the onset of symptoms
does not rule out AMI with certainty. If suspected, repeat the test
at appropriate intervals.
Contact Rebecca Yan