High accuracy One Step Troponin I Rapid Diagnostic Test, diagnosis
of myocardial infarction (MI),quickly
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).
Test Principle:
The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is a
qualitative, membrane based immunoassay for the detection of cTnI
in whole blood, serum or plasma. The membrane is pre-coated with
capture reagent on the test line region of the test. During
testing, the whole blood, serum or plasma specimen reacts with the
particle coated with anti-cTnI antibodies. The mixture migrates
upward on the membrane chromatographically by capillary action to
react with capture reagent on the membrane and generate a colored
line. The presence of this colored line in the test line region
indicates a positive result, while its absence indicates a negative
result. To serve as a procedural control, a colored line will
always appear in the control line region indicating that proper
volume of specimen has been added and membrane wicking has
occurred.
TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior
to testing. Do not open the pouch until ready
to begin testing.
2. Remove the device from the sealed pouch and lay it on a flat and
dry surface.
3. Using the provided pipette, add one drop of fresh specimen to
the sample well.
4. Hold the buffer bottle vertically and add 1 drop to the sample
well. /If using a pipette, change a new one to avoid
cross-contamination. Draw and transfer 2-3 drops of buffer to the
sample well.
5. Read the result between 15-20minutes. Do not read results after
20 minutes.
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the control line
region (C) and another apparent colored line should be in the test
line region (T).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of TP antibodies present in the
specimen. Therefore, any shade of color in the test line region (T)
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line
appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.
PERFORMANCE CHARACTERS:
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 98.4% 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: 98.4%(97.4%-99.6%)*
Accuracy: 98.7%(97.5%-99.4%)*
*95% Confidence Interval
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
