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Myoglobin Rapid Test Device


Short Description:

The Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).



Product Detail

Product Tags

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

ResultsPositiveNegative
Positive59867
Negative0356356

Total Results

59364423

Relative Sensitivity: 100% (99.7%‐100%)*

Relative Specificity: 97.8% (96.3%‐99.3%)*

Accuracy: 98.1% (96.8%‐99.4%)*  95% Confidence Interval


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