Troponin I Rapid Test Device (Serum/Plasma)
KIT COMPONENTS
.Individually packed test devices
.Disposable pipettes
.Buffer
.Package insert
Each device contains a strip with colored conjugates and reactive reagents pre‐spreaded at the corresponding regions，For adding specimens use ，Phosphate buffered saline and preservative For operation instruction.
DIRECTIONS FOR USE
Allow test device, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and level surface.Hold the dropper vertically and transfer 2 drops of specimen (or approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.
Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes
EXPECTED VALUES
The Troponin I Rapid Test Device (Serum/Plasma) has been compared with a leading commercial cTnI EIA test, demonstrating an overall accuracy of 98.7%.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
The Troponin I Rapid Test Device (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 (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 IRapid Test Device | Results | Positive | Negative | |
| Positive | 113 | 6 | 119 | |
| Negative | 2 | 493 | 495 | |
| Total Results | 115 | 499 | 614 | |
Relative Sensitivity: 98.3%(95.9%‐100%)* Relative Specificity: 98.8%(97.8%‐99.8%)* Accuracy: 98.7%(97.8%‐99.6%)* *95% Confidence Interval
