Regulatory status: For research use only, not for use in diagnostic procedures.

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serum, plasma
Species Reactivity
Intended Use
The HCG ELISA Kit is an enzyme immunoassay for the measurement of intact human chorionic gonadotropin (hCG) in serum or plasma. In the United States, this kit is intended for Research Use Only.
Contents of Kit
1. Microtiterwells, 12 x 8 (break apart) strips, 96 wells
2. Standard (Standard 1-5), 5 vials (lyophilized), 1.0 mL;
3. Sample Diluent, 1 vial, 10 mL
4. Enzyme Conjugate, 1 vial, 11 mL
5. Substrate Solution, 1 vial, 14 mL
6. Stop Solution, 1 vial, 14 mL
2°C to 8°C
Performance Characteristics
The range of the assay is between 5 – 1000 mIU/mL.

The following substances were tested for cross reactivity of the assay:
General Description
Chorionic Gonadotropin (hCG) is a glycoprotein hormone which is normally produced by the placenta during pregnancy. After conception, the hCG concentration increases rapidly to reach a peak near the end of the first trimester. High concentrations are observed throughout pregnancy. After delivery, hCG levels fall rapidly and become undetectable after a few days. Structurally intact hCG molecules are composed of an alpha and a beta subunit with a molecular weight of 38.4 kDa. The alpha subunit is nearly identical to the alpha subunits of other glycoprotein hormones, such as Thyroid Stimulating Hormone (TSH), Luteinizing Hormone (LH), and Follicle Stimulating Hormone (FSH): The differences in the beta subunit of the respective hormones account for their biological specificity and immunochemical distinctiveness. Monoclonal antibodies recognizing unique sites on the beta chain of the hCG molecule are essential for differentiation between hCG and LH, FSH and TSH.
HCG Assays are used for the early detection of pregnancy.
1. In addition to the elevated hCG levels during pregnancy, high concentrations of hCG may be associated with neoplasms of trophoblastic and nontrophoblastic origin such as hydatiform mole, chorionepithelioma, embryonal cell carcinoma, and many others.
2. HCG is commonly elevated in different testicular tumors and is thus used as a tumor marker for testicular tumors in combination with AFP. There is a good correlation between changes in hCG levels and response to therapy.
3. Extragonadal germ-cell cancers in the absence of clinically or ultrasonographically detectable testicular abnormalities have beein observed as well. Over 50% of patients with malignant insulinomas have elevated hCG levels: the hormone is not detected in association with benign adenomas. Ectopic secretion of hCG also have been found in a small percentage of patients with adenocarcinoma of the ovary, pancreas and stomach, hepatomas, and islet-cell carcinomas.
Standard Curve
Standard Optical Units (450 nm)
Standard 1 (5 mIU/mL) 0.05
Standard 2 (50 mIU/mL) 0.14
Standard 3 (200 mIU/mL) 0.43
Standard 4 (500 mIU/mL) 0.94
Standard 5 (1000 mIU/mL) 1.54
Reconstitution And Storage
When stored at 2°C - 8°C unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date. Opened reagents must be stored at 2°C - 8°C. Microtiter wells must be stored at 2°C - 8°C. Once the foil bag has been opened, care should be taken to close it tightly again.


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