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Clinical Chemistry 44: 86-91, 1998;
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Right arrow Endocrinology and Metabolism
Right arrow Automation and Analytical Techniques
(Clinical Chemistry. 1998;44:86-91.)
© 1998 American Association for Clinical Chemistry, Inc.

Endocrinology and Metabolism

Rapid, automated assay for progesterone on the Abbott AxSYM(TM) analyzer

David H. Wilsona, William Groskopf, Stephen Hsu, Diane Caplan, Tom Langner, Michael Baumann, Deborah DeManno, Gregg Williams, Don Payette, Cheryl Dagel, Don Lynch, and George Manderino

Department of Fertility, Pregnancy, and Neurodiagnostics, AxSYM R&D, Abbott Diagnostics Division, Abbott Laboratories, Abbott Park, IL 60064.
a Author for correspondence. Fax (847) 938-7920; e-mail wilson{at}apmac.abbott.com.

We describe an automated assay for progesterone (P4) in human serum and plasma with the Abbott AxSYMTM random-access immunoassay analyzer. In this one-step competitive assay, P4 immobilized onto latex microparticles competes with sample P4 for binding to a conjugate of alkaline phosphatase (AP) and anti-P4 antibody. Total CVs ranged from 3.4% to 8.2% in multiple precision studies conducted according to the 20-day NCCLS EP5-T protocol. The detection limit (zero calibrator + 2 SD) was 0.10 µg/L across 36 experiments. Values for diluted samples were 83–116% of expected. Recovery of P4 added to serum specimens was 92–115%. Cross-reactivities with 43 natural and synthetic steroids were 0–6.3%. No significant interference was detected from bilirubin, protein, erythrocytes, hemoglobin, triglycerides, or cholesterol. In a multisite correlation study, AxSYM P4 results compared well with results from a commercial RIA method (n = 1156; r = 0.976; slope = 1.03; y-intercept = 0.04). Assay throughput is >80 tests per hour in batch mode, 60 tests per hour with mixed load list configurations.




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