The CTK FSH ELISA is a solid-phase enzyme-linked immunosorbent assay. The three main kit components are:
1) Solid Micro Wells pre-coated with streptavidin,
2) FSH Calibrators,
3) Liquid FSH Enzyme Conjugate Mixture comprised of two individual antibody conjugates: an anti-human FSH antibody labelled with horseradish peroxidase (HRP-Ab) and an anti-human FSH antibody labelled with biotin (Bio-Ab).
This test is intended for the quantitative determination of follicle stimulating hormone (FSH) level in human serum. It is intended to be used by professionals only. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers.
FSH is a glycoprotein polypeptide hormone in the gonadotropin family that plays an important role in the regulation of normal growth, sexual development, and reproductive function. Abnormal FSH levels have been found during aging, pregnancy, precocious puberty, menopause, castration, throughout hormone therapy, and in a variety of other medical conditions. Understanding optimal levels and accurate measurement of FSH and related hormones, therefore, is very important for both females and males. Immunoassay measurement of FSH in human serum is a first-line approach in assessing FSH levels, providing important information for diagnostic and monitoring purposes.
Analytical Sensitivity: 11 mIU/mL at 2-SD
Specificity: No cross-reactivity with TSH, hCG, LH and PRL
Accuracy: correlation coefficient 0.965 with a reference method
Intra Assay Precision: CV ≤ 4.9%
Inter Assay Precision: CV ≤ 8.6%
Hook Effect: no hook effect up to 1000 mIU/mL