Specimen : WB/S/P
Format : Strip/Cassette/Uncut Sheet
High Accuracy
INTENDED USE One-Step CK-MB test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of CK-MB in human serum, whole blood or plasma specimens as an aid in the diagnosis of myocardial infarction. MATERIAL PROVIDED 1.One-Step CK-MB Test device 2. Instruction for use Sensitivity: CK-MB test can detect CK-MB in serum with concentration of 7.0 ng/ml or greater. Accuracy: | Negative ( 0 ng/ml) | CK-MB ( 0.8 – 6.9 ng/ml) | CK-MB ( ≥ 7.0 ng/ml) | Number of specimen | 43 | 26 | 50 | Negative | 43 | 21 | 0 | Positive | 0 | 5 | 50 | Specificity/Sensitivity | 100% | 19.2% | 100% |
Interference testing: The following substances were added to CK-MB negative and 7.0 ng/ml CK-MB spiked serum samples. No interference was found with any of the substances at the following concentrations: Bilirubin 10 mg/dl Cholesterol 800 mg/dl Hemoglobin 250 mg/dl Triglyceride 500 mg/dl |
CKMB Test Kits
