CE Certification TES test Reagent Manufacturer – CK-MB/cTnI/MYO – Aehealth

Performance Characteristics

Detection Limit:

CK-MB: 2.0 ng/mL; cTnI: 0.1 ng/mL; Myo: 10.0 ng/mL.

Linear Range:

CK-MB: 2.0-100.0 ng/mL; cTnI:  0.1-50.0 ng/mL; Myo: 10.0-400.0 ng/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 standardized accuracy calibrator is 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.

Troponin I is composed of 205 amino acids with a relative molecular weiaht of about 24KD. It is a protein rich in alpha helix; it forms a complex with cTnT and cTnc, and the three have their own structure and function.After myocardial injury occurs in humans, myocardial cells rupture, and troponin I is released into the blood circulatory system, which increases significantly within 4 to 8 hours, reaches a peak value in 12 to 16 hours after myocardial injury, and maintains a high value for 5 to 9 days

Troponin I has a high degree of myocardial specificity and sensitivity, and is currently the most idea biomarker of myocardial infarction.
Creatine Kinase (CK) has four isoenzyme forms: muscle type (MM), brain type (BB), hybrid type (MB) ano mitochondrial type (MiMi). Creatine kinase is contained in many tissues, but the distribution of each isoenzyme is different. Skeletal muscle is rich in M-type isoenzymes, while brain, stomach, small intestine bladder and lunas mainly contain B-type isoenzymes. MB isoenzymes account for about 15% to 20% of total CK, and they only exist in myocardial tissue. This feature makes it a diagnostic value, making it the most valuable enzyme marker for diagnosing myocardial injury Things. The presence of CK-MB in the blood indicates suspected myocardial damage. CK-MB monitoring is very important for the diagnosis of myocardial ischemia

Myoglobin (Myoglobin, Myo) is a binding protein composed of a peptide chain and a heme prosthetic qroup It is a protein that stores oxygen in the muscle. It has a small molecular weight, about 17,800 Daltons, whicl can be very fast It is released rapidly from the ischemic myocardial tissue, so it is a good early diagnostic indicator of ischemic myocardial injury, and the negative result of this indicator is particularly helpful to rule out myocardial infarction, and its negative predictive value can reach 100%. Myoglobin is the first non enzymatic protein used to diagnose myocardial injury. It is a highly sensitive but not specific diagnostic index tis also a sensitive and rapid marker for re-obstruction after coronary recanalization.