| PRODUCT NAME: |
ST AIA-PACK PSA II |
| INTENDED USE: |
ST AIA-PACK PSA II is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of prostate specific antigen (PSA) in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Prostate Specific Antigen (PSA) is a single chain glycoprotein confined to the cytoplasm of prostatic acinar cells and ductal epithelium. The presence of PSA has been demonstrated in normal, benign hyperplastic and malignant prostatic tissue in metastatic prostatic carcinoma and also in prostatic fluid as well as seminal plasma. Elevated serum PSA levels have been reported in patients with prostate cancer, benign prostatic hypertrophy or inflammatory conditions of their genitourinary tissues. Especially in patients treated with hormone therapy, concurrent serial determinations of PSA and PAP may provide additional clinical value in monitoring patients with prostatic cancer. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 0.2, 2.0, 10.0, 50.0, 110.0 ng/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
0.01 - 100 ng/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK PSA II |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK PSA II CALIBRATOR SET
AIA-PACK PSA II SAMPLE DILUTING SOLUTION
AIA-PACK WASH CONCENTRATE
AIA-PACK DILUENT CONCENTRATE
AIA-PACK DETECTOR STANDARDIZATION TEST CUP
AIA-PACK SAMPLE TREATMENT CUP
SAMPLE CUPS |
*Please refer to the product Instruction-For-Use (IFU) for complete details.