FEMTELLE™ uPA/PAI-1 ELISA REF: 899
CE Marked
Prospective, randomized multi-center clinical trials as well as retrospective meta-analyzes have shown that measurement of both uPA and PAI-1 levels in extracts of breast cancer tumor tissue can help to assess the risk of disease recurrence. FEMTELLE results are useful for the following indications:1. Prognosis for breast cancer patients who are either at low or high risk for disease recurrence following surgery. A low level of both uPA and PAI-1, below the established cutoff value of 3 ng uPA/mg of total protein and 14 ng of PAI- 1/ mg total protein, places the patient in the low risk category for disease recurrence. A high level of uPA and/or PAI-1, above the respective cut-off values, correlate with a significantly shortened Disease Free Survival (DFS) and reduced Overall Survival (OS) as compared to patients with tumor tissue containing low levels.2. Prediction: It has been proposed that uPA and PAI-1 levels may be used to predict patient response to adjuvant chemotherapy. Clinical trials suggest that breast cancer patients with low uPA and PAI-1 are unlikely to benefit from adjuvant chemotherapy, whereas those patients with high uPA and PAI-1 levels are more likely to benefit from adjuvant chemotherapy.
Results from FEMTELLE should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer disease
| REAGENTS | |
|---|---|
| 96 | Anti-human PAI-1 IgG coated microwells |
| 96 | Anti-human uPA IgG coated microwells |
| 6 | Vials of PAI-1 Standards, 0-10 ng/mL, lyophilized |
| 6 | Vials of uPA Standards, 0-1.0 ng/mL, lyophilized |
| 2 | Vials of Detection Antibody, biotinylated anti-human PAI-1, lyophilized |
| 2 | Vials of Detection Antibody, biotinylated anti-human uPA, lyophilized |
| 1 | Vial of PAI-1 Enzyme Conjugate, Streptavidin-Horseradish Peroxidase, 60 μL |
| 1 | Vial of uPA Enzyme Conjugate, Streptavidin-Horseradish Peroxidase, 60 μL |
| 2 | Vials of Enzyme Conjugate Diluent, 20 mL, lyophilized |
| 2 | Vials of Substrate, TMB, 11 mL |
| 2 | Vials of Detergent, 25% Triton X-100, 12 mL |
| 2 | Packets of TBS Buffer, pH 9.6, powder |
| 4 | Packets of PBS Buffer, pH 7.4, powder |
| SPECIFICATIONS | |
|---|---|
| SAMPLES | Detergent extracts of tumor tissue |
| SAMPLE PREPARATION | 1:20 dilution in sample buffer |
| SAMPLE VOLUME | 100 μL of diluted sample |
| TOTAL ASSAY TIME | 2½ days, including detergent extraction |
| STANDARD RANGE PAI-1 | 0 – 10 ng/mL |
| LOWER LIMIT OF DETECTION, PAI-1 | 0.125 ng/mL |
| PRECISION, PAI-1 | Intra-assay CV = 6.7%Inter-assay CV = 4.7% |
| STANDARD RANGE, UPA | 0 – 1.0 ng/mL |
| LOWER LIMIT OF DETECTION, UPA | 0.025 ng/mL |
| PRECISION | Intra-assay CV <>Inter-assay CV <> |
| NUMBER OF TESTS | 96 |
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