| PRODUCT NAME: |
ST AIA-PACK Testosterone |
| INTENDED USE: |
ST AIA-PACK Testosterone is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of testosterone in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Testosterone is one of the male hormones (androgens) in men. This steroid hormone is secreted by the testes mainly due to LH stimulation. By measuring the level of testosterone together with those of LH and FSH, it is possible to assess the function of the hypothalamus-pituitary-testicular axis. Thus testosterone assay is used for diagnosis of testicular insufficiency. In addition, the level of testosterone is measured to assess male hormone suppression in prostate cancer patients on antiandrogen therapy. In women, testosterone is mainly derived from the adrenal gland and ovary. Abnormal virilism of women can be caused by excessive secretion of adrenal androgens, or masculinizing ovarian tumor or masculinizing adrenal gland tumor and in such a case, it is useful to measure the level of testosterone. Because the level of testosterone is relatively high in polycystic ovary syndrome (PCOS), which can cause infertility, thus testosterone assay is used as an auxiliary diagnostic test. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Competitive enzyme immunoassay |
| Calibrators: |
0, 30, 100, 350, 900, 2200 ng/dL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
7 - 200 ng/dL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK Testosterone |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK Testosterone CALIBRATOR SET
AIA-PACK Testosterone 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.