Progesterone Saliva ELISA

Intended Use
Enzyme immunoassay for the quantitative determination of progesterone in human saliva.

Intended Purpose
The Progesterone Saliva ELISA is intended for the quantitative determination of Progesterone in human saliva in adults and for use as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.

The information in addition to other clinical observations and diagnostic test is useful in assessing the level of progesterone as a determination of physiological status in adults. Changes in progesterone level demonstrates abnormal hormone productions and can be indicative for disorders of the ovaries or placenta. The Progesterone Saliva ELISA is NOT appropriate for use in the diagnosis and treatment of abnormalities of pregnancy.

The Progesterone Saliva ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. The assay is adaptable by laboratory personnel to automate on open ELISA based liquid handler platforms; however, the programming of the steps and timing required by the manual kit assay test instructions must be strictly adhered to and verified by the laboratory.
Test results may be calculated manually from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges). The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use. The device is not intended for point-of-care settings.

Summary and Explanation
Progesterone derives from the precursor cholesterol,[1] belongs to the group of steroid hormones called progestins [2] and is the major progestogen in the body involving different functions within the human physiology throughout life.[3] Progesterone is produced both in men and in women by the adrenal cortex and gonads. In women progesterone is synthesized in different tissues from pregnenolone: in the adrenal cortex, corpus luteum of the ovaries, during pregnancy by the placenta [3] and in small amounts in the adrenal cortex.

As a metabolic intermediate it serves in the production of steroids like aldosterone, cortisol, testosterone and 17-â-estradiol having a variety of crucial functions in the body.[4] Although progesterone is found in women and men, the role in men is less intensive studied,[5] however, it is involved in spermiogenesis, sperm capacitation-acrosome reaction and androgen biosynthesis in Leydig cells.[6] The role of progesterone in women involves the function in ovulation, pregnancy, menstrual cycle and menopause and in this regard the function of ovaries and placenta.[7-10]

The main part of progesterone can be found as bound to globulin (CBG-corticosteroid binding globulin, Transcortin), to the sex hormone binding globulin (SHBG) and albumin. Only 1 - 2 % of progesterone circulates freely available and presents the active part in plasma. “Thus, salivary steroids are thought to reflect the concentration of unbound serum steroids. In this respect the salivary concentrations may be a better measure of the exposure of target organs to the steroids than the serum concentrations are […]”.[11] Therefore, the measurement of progesterone in saliva is very attractive for clinicians due to its manifold advantages over venipuncture e.g. easy collection, non-invasive, less painful and stressful for the patient and multiple sampling possible

Benefit of Standardized reagents
Our Saliva ELISA product line has been revised so that the main steroids (cortisol, testosterone, progesterone, DHEA) may be processed in a similar way:

• The TMB, stop solution and wash solution have the same design within Cortisol, Testosterone and DHEA saliva ELISA (RE52611, RE52631 and RE52651)*
• The enzyme conjugate, the substrate and stop solutions are uniformly pipetted with 100 µL;
• The kits contain 6 standards and 2 controls;
• 2 Only 50 µL sample volume is required;
• All kits use the same sample diluent buffer.

Pulsatile dynamics
Due to the pulsatile dynamics of steroid secretion repeated saliva sampling is recommended. IBL recommends collecting 3 to 5 saliva samples within 2 hours. In the laboratory, equal volumes of the individual saliva samples can be mixed. This mixed sample results in a mean free Progesterone value, which represents the active hormone concentration in a reproducible way.

For concrete data please consult the Instruction for Use in the download box on the top right side.