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Comparison of three methods for 17 alpha-hydroxyprogesterone

V D Castracane1, T Gimpel

  • 1Texas Tech University Health Sciences Center, Department of Obstetrics and Gynecology, Amarillo, USA.

Journal of Clinical Laboratory Analysis
|January 1, 1997
PubMed
Summary

This study compared three 17 alpha-hydroxyprogesterone (17 alpha-OHP) assay kits. Diagnostic Systems Laboratories (DSL) kits showed similar performance and are recommended for measuring 17 alpha-OHP during pregnancy.

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Area of Science:

  • Endocrinology
  • Clinical Chemistry
  • Assay Development

Background:

  • Accurate measurement of 17 alpha-hydroxyprogesterone (17 alpha-OHP) is crucial for diagnosing various endocrine disorders.
  • Existing immunoassay kits vary in performance, necessitating comparative studies.

Purpose of the Study:

  • To compare the performance of three commercially available 17 alpha-hydroxyprogesterone (17 alpha-OHP) assay kits.
  • To evaluate the suitability of these kits for different populations, including pregnant women.

Main Methods:

  • Comparative analysis of two Diagnostic Systems Laboratories (DSL) kits (double antibody and coated tube) and one Diagnostic Products Corporation (DPC) coated tube kit.
  • Assay validation included sensitivity, precision, linearity, recovery, and specificity.

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  • Analysis of 190 human samples from diverse groups: prepubertal, adult males, cycling females, oral contraceptive users, post-menopausal women, and pregnant women.

    • Main Results:

    • The two DSL kits demonstrated similar performance across all validation parameters.
    • 17 alpha-OHP levels correlated reasonably well between DSL and DPC kits in most populations.
    • The DPC kit showed significantly higher 17 alpha-OHP values in the 2nd and 3rd trimesters of pregnancy, suggesting potential interference.

    Conclusions:

    • The DSL assay kits exhibit consistent performance and may be more suitable for accurate 17 alpha-OHP measurement during pregnancy.
    • Potential interference in the DPC assay during pregnancy warrants caution when interpreting results from this kit.