| PRODUCT NAME: |
ST AIA-PACK HCG |
| INTENDED USE: |
ST AIA-PACK HCG is designed for IN-VITRO DIAGNOSTIC USE for the quantitative measurement of human chorionic gonadotropin in human Serum and heparinized plasma or urine 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. Structurally, hCG consists of two subunits; α and β , which are bound by a non-covalent bond. While the amino acid sequence of the α-subunit of hCG is the same as that of the α-subunit of thyroid stimulating hormone (TSH), follicle stimulating hormone (FSH) and luteinizing hormone (LH), which are secreted from the anterior pituitary gland but the β-subunit of these hormones is unique to each. However, the β-subunit of hCG and that of LH have a high degree of homology in amino acid sequence, and the distinct difference between these two hormones is in C-terminal 30 amino acids (CTP). 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 and urine |
| Assay range: |
Serum and heparinized plasma: 0.5 - 400 mIU/mL
Urine: 2.5 - 2000 mIU/mL (5 times dilution case) |
| Reaction time: |
10 minutes |
| Storage: |
2 - 8 ºC |
| Kit Contents: |
ST AIA-PACK HCG |
| Consumables: |
AIA-PACK SUBSTRATE SET II
AIA-PACK HCG CALIBRATOR SET
AIA-PACK HCG SAMPLE DILUTING SOLUTION
AIA-PACK WASH CONCENTRATE
AIA-PACK DILUENT CONCENTRATE
SAMPLE CUPS
AIA-PACK SAMPLE TREATMENT CUP
AIA-PACK DETECTOR STANDARDIZATION TEST CUP |
*Please refer to the product Instruction-For-Use (IFU) for complete details.