Myoglobin Rapid Test Device
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
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
EXPECTED VALUES
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been compared with a leading commercial Myoglobin EIA test, demonstrating an overall accuracy of 98.1%.
PREFORMANCE CHARACTERISTICS
Sensitivity and Specificity
The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with a leading commercial Myoglobin EIA test using clinical specimens. The results show that the sensitivity of the MYO Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is 100% and the specificity is 97.8% relative to the leading EIA test.
Myoglobin Rapid Test vs. EIA
Method | EIA |
Total Results | ||
Myoglobin Rapid Test | Results | Positive | Negative | |
| Positive | 59 | 8 | 67 | |
| Negative | 0 | 356 | 356 | |
Total Results | 59 | 364 | 423 | |
Relative Sensitivity: 100% (99.7%‐100%)*
Relative Specificity: 97.8% (96.3%‐99.3%)*
Accuracy: 98.1% (96.8%‐99.4%)* 95% Confidence Interval
