
Tests for quantitative determination of cancer markers in human specimen by microplate enzyme immunoassay, colorimetric.
Part #: Refer to the IFUs
Manufacturers:
Cancer markers are a group of substances such as proteins, hormones, enzymes, receptors and other cellular products that are produced in higher-than-normal concentrations by tumor cells. These markers may be detected in the blood of individuals with cancer. Specific tumor markers are associated with certain malignancies; for example, alpha-fetoprotein (AFP) is used in the evaluation of liver cancer and germ cell tumors, prostate-specific antigen (PSA) for prostate cancer, CA 15-3 for breast cancer, CA 125 for ovarian cancer, carcinoembryonic antigen (CEA) for colorectal cancer and CA 19-9 for cancers of the pancreas, gallbladder, bile duct and stomach.
When used in conjunction with other diagnostic methods, these tests assist in cancer diagnosis, monitoring treatment response, evaluating the need for surgical intervention and assessing disease recurrence.
Technical specifications
| Analyte | Principle | Calibrator Concentration | Measurement Range | Assay Time |
| AFP | Sandwich assay | 0, 5, 25, 50, 250, 500 ng/mL | 0.44 – 500 ng/mL | 75 minutes |
| AFP (VAST Kit) | Sandwich assay | 0, 5, 25, 100, 250, 500 ng/mL | 0.454 – 500 ng/mL | 75 minutes |
| CEA | Sandwich assay | 0, 5, 10, 25, 50, 250 ng/mL | 0.816 – 250 ng/mL | 75 minutes |
| CEA (VAST) | Sandwich assay | 0, 5, 10, 25, 50, 250 ng/mL | 0.078 – 250 ng/mL | 75 minutes |
| tPSA | Sandwich assay | 0, 5, 10, 25, 50, 100 ng/mL | 0.013 – 100 ng/mL | 45 minutes |
| tPSA (VAST) | Sandwich assay | 0, 2, 5, 10, 25, 50 ng/mL | 0.041 – 50 ng/mL | 75 minutes |
| fPSA | Sandwich assay | 0, 0.5, 1, 2.5, 5, 10 ng/mL | 0.008 – 10 ng/mL | 75 minutes |
| CA 125 | Sandwich assay | 0, 15, 50, 100, 200, 400 U/mL | 1 – 400 U/mL | 75 minutes |
| CA 19-9 | Sandwich assay | 0, 10, 50, 100, 250, 500 U/mL | 1 – 500 U/mL | 135 minutes |
| CA 15-3 | Sandwich assay | 0, 10, 40, 100, 200, 400 U/mL | 0.2 – 400 U/mL | 140 minutes |
Refer to the product Instruction-For-Use (IFU) for complete details.