Testosterone Saliva ELISA

Enzyme immunoassay for the quantitative determination of Testosterone in human saliva.

INTENDED USE:For the quantitative measurement of Testosterone in human saliva by an ELISA (Enzyme-Linked Immunosorbent Assay). This kit is intended for professional use only and is for laboratory use only. For in vitro diagnostic use only. Intended to be used manually but may be adaptable to open automated analyzers. The user is responsible for validating the performance of this kit with any automated analyzers.

GENERAL INFORMATION:Testosterone is a C-19 steroid secreted from the testis and the adrenal cortex in men and from the adrenal cortex and ovaries in women. Testosterone is also produced by peripheral tissues from androstenedione, which is of little physiological significance in men. However, in women about half of the circulating testosterone is derived from this origin. The action of testosterone is both androgenic and anabolic. Testosterone measurements are used mainly for clinical evaluation of hypogonadism in males and hyperandrogenic states in females. Most of the circulating testosterone is bound to three proteins: sex hormone binding globulin (44–78%), albumin (20–54%) and cortisol binding globulin (small amount). Only about 2–3% of the total circulating testosterone remains unbound or in the free form. Only the free portion (or the non-SHBG bound fraction) of the circulating testosterone is thought to be available to tissues where it exerts its biological actions. The salivary hormone assays are advocated for their non-invasive sample collection method. Salivary testosterone is of great clinical value as it represents a filtered fraction of plasma testosterone and is independent of salivary flow rate. Many studies have suggested that salivary testosterone correlates well with either free or non-SHBG bound testosterone.

KIT CHARACTERISTICS:
- Method: ELISA
- Tests: 96
- Incubation Time / Conditions: 1 h, 30 min (RT/shaker)
- Standard Range: 10 - 1,000 pg/ml
- Sensitivity analytical: LoD: 6.75 pg/ml
- Final Sample Volume: 100 µl
- Sample Type: saliva
- Sample Pretreatment: freeze-thaw-cyclus
- Isotope / Substrate: TMB 450 nm
- Internal Controls: 2
- Regulatory Status: CE