Rapid, automated assay for progesterone on the Abbott AxSYM analyzer

Area of Science:

• Clinical Chemistry
• Immunoassay Development
• Biomarker Analysis

Background:

• Progesterone (P4) is a critical hormone in reproductive health and pregnancy.
• Accurate and efficient measurement of P4 is essential for clinical diagnosis.
• Existing methods for P4 analysis may have limitations in throughput or automation.

Purpose of the Study:

• To develop and validate an automated, one-step competitive immunoassay for progesterone (P4) determination.
• To evaluate the performance characteristics of the new assay using the Abbott AxSYM analyzer.
• To assess the assay's suitability for routine clinical laboratory use.

Main Methods:

• A one-step competitive immunoassay format was employed.
• Progesterone (P4) was immobilized on latex microparticles.
• Alkaline phosphatase (AP)-conjugated anti-P4 antibody was used as the detection system.
• Assay performance was evaluated using NCCLS EP5-T protocols and multisite correlation studies.

Main Results:

• The assay demonstrated high precision with total CVs ranging from 3.4% to 8.2%.
• The detection limit was 0.10 microg/L, with excellent recovery (83-116%) and accuracy (92-115%).
• Minimal cross-reactivity (<6.3%) and interference from common biological substances were observed.
• Strong correlation (r=0.976) was found with a commercial RIA method.
• High throughput achieved: >80 tests/hour (batch) and 60 tests/hour (mixed load).

Conclusions:

• The automated Abbott AxSYM P4 assay is precise, accurate, and robust.
• The assay shows minimal interference and cross-reactivity, ensuring reliable results.
• Its high throughput and strong correlation with RIA make it suitable for routine clinical use.