Cardiac Troponin I (cTnI)One Step Test with CE certificate Test Device
| Product Name | Cardiac Troponin I (cTnI) One Step Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
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).
Sensitivity and Specificity
The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) has
been evaluated with a leading commercial cTnI EIA test using
clinical specimens. The results show that the sensitivity of the
Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is 98.3%
and the specificity is 98.8% relative to the leading EIA test.
Troponin I Rapid Test Device vs. EIA
| Method | EIA Test | Total Results |
| Troponin I Rapid Test Device | Results | Positive | Negative |
| Positive | 113 | 6 | 119 |
| Negative | 2 | 493 | 495 |
| Total Results | 115 | 499 | 614 |
Relative Sensitivity: 98.3%(93.9%-99.8%)* Relative Specificity:
98.8%(97.4%-99.6%)*
Accuracy: 98.7%(97.5%-99.4%)* *95% Confidence Interval
SUMMARY
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.
