Diagnostic Salivary Estradiol,17ß EIA, IVD

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Diagnostic Direct Salivary Estradiol, 17ß Enzyme Immunoassay

Quantitative measurement of salivary Estradiol 17ß

IVD, FDA Registered

674

Enzyme Immunoassay (EIA), Colormetric

1 pg/mL – 32 pg/mL

0.5 pg/mL

100 µL

2hr @ Room Temperature

96 wells

450 nm

2° - 8°C

9 months

Summary and Assay Principle:

17 ß-Estradiol (E2) is a steroid hormone produced mainly by the Graafian follicle of the ovary in female and in small amounts by the testes in male subjects. E2 is biologically the most active of naturally produced human estrogens. The majority of E2 (98%) is bound to sex hormone binding globulin (SHBH) and to a lesser extent to other serum proteins such as albumin. Only a small fraction circulates in the free form or conjugated to sulfates and glucuronides (2,3). In non-pregnant women there is a cyclic variation in the concentration of E2, the highest values being measured usually the day before ovulation (4,5). Positive feedback influence of this peak value is considered essential for occurrence of the mid cycle luteinizing hormone (hLH) peak and consequently, for ovulation (6). During pregnancy the E2 concentration

increases considerably and remains high throughout pregnancy (7).

The assay of E2 is a valuable tool for assessing the etiology of amenorrhea and/or infertility in female subjects. It is also a useful aid in monitoring ovulation induction treatment with clomiphene citrate, LH-RH (LH-releasing hormone) or exogenous gonadotropins (8,9). In male subjects, serum E2 measurements are used for investigating feminizing syndromes (10).

Assay Principles:

The Pantex Direct Salivary 17β-Estradiol EIA Kit, Cat #674, is based on the
competition principal and microplate separation. An unknown amount of estradiol present in a saliva sample and a fixed amount of estradiol conjugated to horse radish peroxidase (E2- HRP) compete for binding sites with a rabbit monoclonal estradiol antiserum bound to GARGG (goat anti-rabbit gamma globulin) coated wells of a microplate. After incubation, unbound components are washed away. Enzyme substrate solution is then added and a
blue color formed. This reaction is stopped with an acid solution to produce a yellow
color. The optical density is then read at 450 nm. The amount of E2-HRP detected is inversely proportional to the amount of estradiol in a sample.