CE Certification β-HCG test Reagent Factories – MYO – Aehealth

Performance Characteristics

Detection Limit:  10.0ng/mL;

Linear Range: 10.0～400ng/mL;

Linear correlation coefficient R ≥ 0.990;

Precision: within batch C.V. is ≤ 15%; between batches C.V. is ≤ 20%;

Accuracy: the relative deviation of the measurement results shall not exceed ± 15% when the accuracy calibrator prepared by Myo national standard or standardized accuracy calibrator are tested.

1. Store the detector buffer at 2～30℃. The buffer is stable up to 18 months.

2. Store Aehealth Ferritin Rapid Quantitative test cassette at 2～30℃, shelf life is up to 18 months.

3. Test cassette should be used within 1 hour after opening the pack.

Myoglobin is a tightly folded, globular heme-protein located in the cytoplasm of both skeletal and cardiac muscle cells. Its function is to store and supply oxygen to muscle cells. The molecular weight of myoglobin is approximately 17,800 daltons. The relatively low molecular weight and the location of storage accounts for the rapid release from damaged muscle cells and earlier rises in concentration measured above baseline in blood as compared to other cardiac markers.

Since myoglobin is present in both cardiac and skeletal muscle, any damage to either of these muscle types results in its release into the blood stream. Serum levels of myoglobin have been shown to elevate under the following conditions: skeletal muscle damage, skeletal muscle or neuromuscular disorders, cardiac bypass surgery, renal failure, strenuous exercise, etc. Therefore, the utilization of an increase in serum myoglobin has to be used in conjunction with other aspects of the patient assessment in order to aid in the diagnosis of an Acute Myocardial Infarction (AMI). Myoglobin may also rise moderately above the reference range in chronic ischemic heart disease (i.e. unstable angina).