| PRODUCT NAME: |
ST AIA-PACK βHCG |
| INTENDED USE: |
ST AIA-PACK βHCG is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of human chorionic gonadotropin (total βhCG) in human serum or heparinized plasma on Tosoh AIA immunoassay analyzers. |
| SUMMARY AND EXPLANATION OF TEST: |
Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone which is synthesized and secreted on placental villi, and it is considered a good indicator of placental function. Determination of hCG and βhCG is widely used for early diagnosis of pregnancy and along with two-dimensional echography. hCG and βhCG assays are widely performed for diagnosis of abnormal pregnancies such as spontaneous abortions or ectopic pregnancies.
While hCG is generally found in the blood during pregnancy, its level is elevated in chorionic carcinoma and chorionic diseases. hCG is produced by the placenta shortly after implantation and increases at a geometric rate until it reaches a peak near the end of the first trimester. This makes it an excellent marker for the confirmation of pregnancy and/or monitoring its thereafter when necessary. Other conditions associated with elevated serum hCG concentrations are neoplasm's of trophoblastic and non-trophoblastic origin. |
| TECHNICAL SPECIFICATIONS: |
|
Method: |
Enzyme Immunoassay (EIA) |
| Principle: |
Two-site immunoenzymometric assay |
| Calibrators: |
0, 200 ng/mL |
| Assay sample: |
Serum and heparinized plasma |
| Assay range: |
0.5 - 400 mlU/mL |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK βHCG |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK βHCG CALIBRATOR SET
AIA-PACK βHCG 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.