IVD Reagents

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The Eclectica Progestesterone assay for the Eclectica analyzers has been designed for the quantitative determination of Progesterone in human serum and heparinized plasma. The method can be used to measure Progesterone concentrations over the range of 0.2 to 40 ng/ml (0.64 – 128 nmol/l).

Progesterone is the first biologically active compound in the steroid biosynthetic pathway, formed in the adrenal cortex, the testes in males and the ovaries and feto-placental unit in females (1). The major metabolite of progesterone is pregnanediol-3-glucuronide (2). LH regulates the synthesis and secretion of progesterone from the corpus luteum. Following the mid-cycle LH surge, corpus luteum development begins, with progesterone levels increasing (3). Maximal levels are reached 5-8 days post ovulation, decreasing to follicular phase levels prior to menstruation if implantation does not occur. If implantation occurs progesterone levels remain elevated and increase progressively throughout the ensuing pregnancy (1).

Approximately 1% of the total progesterone circulation in blood is not bound to proteins. A further 1% is bound to amino globulin. Approximately 48% is bound to albumin, with a higher affinity (ka = 1 x 104 l/mol) than other steroid hormones. The remaining 48% is bound to cortisol binding globulin with high affinity (ka = 1 x 103 l/mol) (4).

The major role of progesterone is to prepare the uterus for implantation, and for the early maintenance of pregnancy. It also acts in conjunction with prolactin to prepare the breast for lactation (5). Clinically progesterone measurement is of use to monitor ovarian function, confirm ovulation, assess luteal phase defects, and to check the effectiveness of procedures for induction of ovulation (6, 7, 8).

The use of integrated luteal progesterone measurements have been suggested to be an accurate assessment of luteal function in addition to, or in place of, endometrial biopsy (9). Progesterone levels are elevated in both normal and ectopic pregnancy (10, 11, 12, 13, 14). Serum progesterone measurements have also been used to monitor replacement therapy (15), and to evaluate patients at risk from spontaneous abortion in early pregnancy (15, 16, 11).

The Eclectica assays for the Eclectica analyzers consists of:

1. Eclectica Progesterone Reagent Kit: specific reagents of Eclectica Progesterone kit to execute the test and to verify the standardization.
2. Eclectica Progesterone Calibration Kit: for standardization.
3. Eclectica Immunoassay Common Reagents Kit: for general chemistry reaction.
4. Eclectica Immunoassay Wash Solution: Wash Solution specific for Immunological reaction.
5. Eclectica Systemic Wash Solution: Wash Solution of Eclectica system.

In the Eclectica Progesterone assay, a mouse monoclonal anti-progesterone antibody is used in an enzyme immunoassay system which incorporates magnetic solid phase separation. All incubation times and reagent volumes are determined by an assay specific software protocol.

Fixed amounts of fluorescein-conjugated anti-Progesterone monoclonal antibody and a progesterone derivative conjugated to alkaline phosphatase are added to a sample, control, or standard. The reactants are incubated at 37°C. During the incubation progesterone in the sample,control or calibrators competes with the derivative for binding to the anti-progesterone antibody.

At the end of the incubation period anti-fluorescein coupled to a magnetic solid phase is added in excess. This rapidly and specifically binds to the progesterone - monoclonal antibody complex and is sedimented in a magnetic field.

After aspirating the liquid phase and washing the solid phase, a solution of the enzyme substrate, phenolphthalein monophosphate is added to the incubation cell and the each cell incubated at 37°C. After incubation the enzyme reaction is stopped by the addition of a stop reagent and the intensity of the color developed is measured photometrically. The intensity of the color developed is inversely proportional, within the working range of the assay, to the concentration of Progesterone in the sample. The concentration of Progesterone in a patient sample or control is then determined by interpolation from a stored standard curve.

Eclectica Progesterone Reagent Kit

Eclectica Progesterone Calibration Kit

Eclectica Immunoassay Common Reagents Kit

Eclectica Immunoassay Wash Solution

Eclectica Systemic Wash Solution

1700006 Eclectica Cleaning Kit