- Analytical Sensitivity: 10 mIU/mL at 2-SD
- Specificity: No cross-reactivity or interference with 1000 mIU/mL TSH, 10,000 mIU/mL FSH, 1,000 mIU/mL LH, 5,000 ng/mL PRL, 1 mM/mL Bilirubin, 10 µg/mL Hemoglobin, 10 µg/mL Lipids
- Accuracy: correlation coefficient 0.979 at normal range or 0.960 during early pregnancy with a reference method
- Intra Assay Precision: CV ≤ 6.5%
- Inter Assay Precision: CV ≤ 10.5%
- Hook Effect: no hook effect up to 50,000 mIU/mL
hCG ELISA CE
A solid-phase enzyme-linked immunosorbent assay based on the principle of the double antibody sandwich technique for quantitative determination of human chorionic gonadotropin (hCG) in human serum.
The three main kit components are:
1) Solid microwells pre-coated with streptavidin,
2) hCG Calibrators,
3) Liquid hCG Enzyme Conjugate Mixture comprised of two individual antibody conjugates: an anti-human hCG antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human hCG antibody labelled with biotin (Bio-Ab).
The CTK hCG ELISA is intended to be used only by professionals only. Any interpretation or use of this test result must also integrate other clinical findings as well as on the professional judgment of health care providers.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone that plays an important role in the female reproductive system. hCG is involved in maintenance of the corpus luteum and progesterone production, as well as various other functions, such as development of the umbilical cord, development of fetal organs, angiogenesis, suppression of uterine contractions, immunosuppression and protection from invading cells.
hCG is detectable in the blood and urine. Abnormally low levels of hCG during pregnancy may indicate issues such as a failing pregnancy, placental insufficiency, ectopic pregnancy, fetal death, preeclampsia, and pre-term delivery. High levels of hCG during pregnancy may indicate multiple pregnancies, molar pregnancy, or gestational miscalculation. Accurate quantification of hCG levels is very important for diagnosis and monitoring of pregnancy. Immunoassays utilizing hCG-specific antibodies to detect and quantify hCG are a first-line approach that provide accurate and reliable results. The CTK hCG ELISA can be used for diagnosis and monitoring of pregnancy.
- Streptavidin Coated Microwells
- hCG Calibrators:
- C1 (0 mIU/mL)
- C2 (5 mIU/mL)
- C3 (10 mIU/mL)
- C4 (25 mIU/mL)
- C5 (50 mIU/mL)
- C6 (100 mIU/mL)
- hCG Assay Control
- hCG Enzyme Conjugate Mixture
- Wash Buffer (40X Concentrate)
- TMB Substrate
- Stop Solution
- Product Insert
- ELISA Working Sheet
- 2 x Microplate Sealers and 1 x Resealable Plastic Bag
FOR EXPORT ONLY