Direct solid-phase chemiluminescence immunoassay for salivary progesterone

Area of Science:

• Biochemistry
• Immunology
• Analytical Chemistry

Background:

• Salivary progesterone measurement offers a non-invasive alternative to serum analysis.
• Accurate and reliable assays are needed for monitoring hormonal fluctuations.

Purpose of the Study:

• To develop and validate a simple, direct chemiluminescence immunoassay (CLIA) for quantifying progesterone in mixed, unstimulated saliva.

Main Methods:

• Utilized purified polyclonal anti-progesterone antibodies coupled to polyacrylamide beads.
• Employed progesterone-11 alpha-hemisuccinyl-aminobutylethyl isoluminol as the chemiluminescent marker.
• Separated bound and free ligand via centrifugation.

Main Results:

• Achieved a detection limit of 1.5 pg/tube (38 pmol/L).
• Demonstrated low intra- and interassay coefficients of variation (e.g., 6.8% and 6.9% for medium concentrations).
• Reported high analytical recovery (99.6%) and good correlation with serum progesterone (r=0.88).

Conclusions:

• The developed chemiluminescence immunoassay is simple, fast, and reliable for salivary progesterone determination.
• Salivary progesterone levels varied significantly across menstrual cycle phases.
• This assay provides a valuable tool for non-invasive hormonal monitoring.