Performance Characteristics
Detection Limit: 3.0 U/mL;
Linear Range: 3-500 U/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 CA15-3 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.
CA15-3 is a highly polymorphic glycoprotein belonging to the mucin family and is the product of the MUC-1 gene. Elevated CA15-3 test values have been reported in individuals with non-malignant diseases such as ovarian and breast cirrhosis, hepatitis, autoimmune disorders, and benign diseases. The reported non-breast malignant diseases with elevated CA15-3 test values include: lung, colon, pancreas, early hepatitis, ovary, uterus, and endometrium. In the most normal individuals, the CA15-3 test value did not increase.