| PRODUCT NAME: |
ST AIA-PACK PROG |
| INTENDED USE: |
ST AIA-PACK PROG is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of progesterone in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Progesterone is a steroid hormone produced mainly by the ovary and adrenal cortex in females. Progesterone is secreted in small amounts by the ovaries during the follicular phase of the menstrual cycle and increases sharply following ovulation and corpus luteum development. Unless pregnancy occurs, a steep decline to follicular levels occur prior to the next menstrual cycle. This pattern makes serum progesterone measurement a reliable method for ovulation detection. Progesterone levels are considered the most accurate means for documenting luteal phase defect. Measurement of progesterone in blood can also be used to detect and evaluate patients at risk for abortion during the early weeks of gestation. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Competitive enzyme immunoassay |
| Calibrators: |
0, 0.5, 1.5, 5.0, 15, 45 ng/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
0.1 - 40 ng/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK PROG |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK PROG CALIBRATOR SET
AIA-PACK PROG 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.