| PRODUCT NAME: |
ST AIA-PACK FSH |
| INTENDED USE: |
ST AIA-PACK FSH is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of follicle stimulating hormone (FSH) in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
FSH is secreted from the anterior pituitary gland. Secretion of FSH is stimulated by gonadotropin releasing hormone (GnRH) secreted from the hypothalamus. In women, the secretion is subjected to a complicated feedback mechanism involving estrogens (E2 and others) and progesterone. In the ovary, follicular development is mostly under the control of FSH. Ovulation is induced by massive secretion of LH (LH surge), and the LH secretion stimulates the corpora lutea to facilitate the production of progesterone. FSH and LH assays are important when a hypothalamus-pituitary gonadal axis abnormality is suspected. Primary hypogonadism is generally suspected if the baseline values of FSH and LH are high, but that of E2 (testosterone in men) is low, and secondary hypogonadism is suspected if the baseline values of FSH and LH are low, and that of E2 (testosterone in men) is also low. When the value (or level) of FSH is normal and LH is high, polycystic ovary syndrome (PCOS) is suspected. Determination of FSH concentrations is essential in assessment and monitoring of patients with suspected infertility. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 100 mIU/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
1 - 200 mIU/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK FSH |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK FSH CALIBRATOR SET
AIA-PACK FSH 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.