·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

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.

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%.

• 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