| PRODUCT NAME: |
ST AIA-PACK free PSA |
| INTENDED USE: |
ST AIA-PACK free PSA is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of free prostate specific antigen (free PSA) in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Prostate specific antigen (PSA) is 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. In the blood, PSA, which is immunoreactive, exists in two forms: complex PSA in which PSA is bound plasma proteins and free PSA. In patients with prostate cancer, the ratio of complex PSA is high, so ascertaining free/total PSA (%) (F/T %) is clinically useful in differentiating prostate cancer from benign prostatic hyperplasia. It has been reported that determination of the ratio of free PSA to total PSA, which is lower in the case of prostate cancer than BPH is considered to be an effective tool for discriminating benign prostatic diseases from prostate cancer. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 0.2, 1.0, 5.0, 10.0, 23.0 ng/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
0.02 - 20 ng/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK free PSA |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK free PSAC ALIBRATOR SET
AIA-PACK free PSA 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.