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Troponin-I
Rapid test for the qualitative detection of Cardiac Troponin-I in human serum / plasma
INTENDED USE:

Troponin-I is an in vitro diagnostic test based on immunochromatographic assay. It is designed for qualitative determination of Cardiac Troponin-I (cTnI) in human serum / plasma as an aid in the diagnosis of acute myocardial infarction (AMI).

SUMMARY AND EXAMPLE

Cardiac Troponin-l (cTnl) is a cardiac muscle protein with a molecular weight of 22.5 kilodaltons. Together with Cardiac Troponin T(cTn-T) and cardiac Troponin C(cTn-C), cTnl forms a Troponin complex in heart to play a pivotal role in the transmission of intracellular calcium signal actin-myosin interaction. There are some advantages that cTn-l has more specificity and sensitivity to AMI than cTn-T. The human cTn-l has an additional amino acid residues on its N-terminal that do not exist on the skeletal forms thus making cTn-l a specific marker for indicating cardiac infarction. cTn-l is released into blood after the onset of AMl. However, CK-MB level returns to normal after 36-48 hours, while level of cTn-l remains elevated for up to 6-10 days. The level of cTn-l is very low in normal healthy people, and not detected in patients with skeletal muscle injury. Therefore, cTn-l is a specific marker for diagnosis of AMI. cTn-l level may be falsely increased when the specimen is collected from renal failure patient.

PRINCIPLE OF THE TEST:

Troponin-l is an immunochromatographic assay. When serum / plasma is added to sample well (S), it moves through the conjugate pad and mobilizes gold anti-cTn-l conjugate that is coated on the conjugate pad. The mixture moves along to the membrane by capillary action and reacts with anti-cTn-l antibody that is coated on the test region (T) of the nitrocellulose membrane. If cTn-l is present in the serum / plasma at levels of 0.5 ng/mL or greater, a color pink / purple line appears in the test region (T). If cTn-l is present at a lower levels, or not present in the specimen, NO pink / purple line appear at the test region and one pink / purple line will appear at control line region (C). The sample continues to move to the control region and forms a colored line, indicating the test is working and the result is valid.

KIT COMPONENTS:

1. Test device pouches : Each pouch contains a plastic device, disposable dropper and piece of desiccant pouch. Each device has a strip containing anti cTn-I and rabbit IgG conjugated with colloidal gold, nitrocellulose membrane coated with anti cTn-I at test line region T and Goat anti rabbit IgG at control line region C.

2. Product insert

STOREGE AND SELF LIFE:

Store the test device packaged in a sealed foil pouch at 2 to 30C. Do not freeze. Shelf-life is 24 months from date of manufacturing if stored at recommended storage conditions.

PRECAUTIONS:

1. For in vitro diagnostic use only.
2. Do not use the test device after expiry date.
3. Handle all specimens as potentially infectious.

SPECIMENS COLLECTION AND STORAGE:

1. The serum/plasma specimen may be used as samples and should be collected under standard laboratory conditions.
2. Since cTnl is relatively unstable, it is recommended that fresh samples should be used as soon as possible, Plasma or serum samples may be refrigerated for 24 hours at 2-8C. If plasma or serum samples must be stored for more than 24 hours, they should be frozen at -20C or below.
3. Heat inactivation of specimens, may cause hemolysis and protein denaturation.

TEST PROCEDURE:

1. Bring all materials and specimens to room temperature if stored at 2-8C.
2. Just before use, open the foil pouch by tearing from the V notch provided.
Note: Once the foil pouch is opened, the device should be used as soon as possible.
3. Place the device on a clean, dry and level surface.
Mention the specimen ID on the test device.
4. Add 2-3 drops of serum / plasma into the sample well (S) using provided disposable sample dropper.
5. Read result between 5-20 minutes.
6. Do not interpret result after 20 minutes and after that discard the device in to a biomedical waste container.

INTERPRETAIONS OF RESULTS:

1. Negative:
Appearance of only one pink / purple line at control line region C and NO pink / purple line at test line region T of the result window, indicates that specimen has no cTn-I and result is negative.

2. Positive: Appearance of two pink / purple lines, one at test region T and other at control line region C of the result window, indicates that specimen has cTn-I and result is positive.

3. Invalid If there is no pink / purple line in the control line region C of the result window, the result is invalid. This is due to deterioration of the test device or improper test procedure. Repeat the test with a new test device.

QUALITY COINTORL:

The control line is an internal control of the test reagents and procedure. It will appear if the test has been performed correctly and the reagents are reactive.

LIMITATIONS OF THE TEST:

1. The test result should be used in conjunction with other clinical information such as clinical signs and symptoms and other test results to diagnosis 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 cTnl into the bloodstream.
2. Oscar Troponin-l test only provides qualitative result. A quantitative assay method must be used to determine the cTn-l concentration.
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 finding have been evaluated.
4. Although Oscar Troponin-I test is accurate in detecting cTn-l, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained.
5. Some specimens with a high rheumatoid factor concentration may yield a nonspecific positive result.

EXPECTED VALUES:

Troponin-l test is designed to yield a positive result for cTn-l concentration at 0.5 ng/mL or greater. The time required for blood cTn-l level to reach detectable levels has been found to be 4-6 hours after the onset of symptoms. cTn-l level reaches the maximum concentration after 12-24 hours after the onset, and then remains elevated for 6-10 days in some cases. Therefore, a negative result within the first hour of the onset of symptoms does not rule out AMI with certainty. If suspected. repeat the test at appropriate intervals.

FORMANCE CHARACTERISTICS:

1. Detection Limit: Oscar Troponin-l test can detect cTn-l with concentration
of 0.5ng/mL or greater.
2. Clinical Accuracy: Relative Sensitivity :95%
Relative Specificity : 97%
Accuracy : 96%