title: Performance of the fully automated progesterone assays on the Abbott AxSYM and the Technicon Immuno 1 analyser compared with the radioimmunoassay Progesterone MAIA.
abstract: OBJECTIVE
  Test performance of two automated progesterone assays available on the immunoassay analysers Abbott AxSYM and Technicon immuno 1, respectively, was evaluated in comparison with the radioimmunoassay Progesterone MAIA.
  
  
  METHODS
  For assessment of test performance imprecision, functional sensitivity and linearity of dilution was examined. Correlation with the manual radioimmunoassay was assessed using 122 serum samples over the range 0-110 nmol/L.
  
  
  RESULTS
  Imprecision studies revealed for the AxSYM Progesterone within-run CV's of 1.8-6.4% and day-to-day CV's of 3.5-9.7% (concentration range 2.3-75 nmol/L); Immuno 1 Progesterone: within-run CV's 1.0-7.3%, day-to-day CV's 2.3-7.7% (concentration range 1.2-60 nmol/L). The functional sensitivity was < 1.7 nmol/L for the AxSYM Progesterone and < 1.1 nmol/L for the Immuno 1 Progesterone. With the AxSYM Progesterone the mean recovery after dilution from five samples was 102% (89-107%), from one sample only 69-80% was recovered; with the Immuno 1 Progesterone the mean recovery was 95% (80-105%). Despite of a quite good overall correlation (coefficients 0.972 and 0.981) the relationship of both assays to the Progesterone MAIA significantly deviate from linearity with a considerably higher slope within the lower concentration range. The relationship between the automated assays was linear over the entire concentration range (Immuno = 1.207 * AxSYM + 1; r = 0.986). The time to first result was 20 min for the AxSYM Progesterone, 45 min for the Immuno 1 Progesterone and 90 min for the Progesterone MAIA.
  
  
  CONCLUSIONS
  The evaluated progesterone assays both exhibit an excellent precision and a high degree of sensitivity. They offer a rapid and flexible method for progesterone determination which may be especially useful for the monitoring of ovarian stimulation during in-vitro fertilization.
authors.affiliation: Zentrum für Frauenheilkunde und Geburtshilfe, Universität Bonn, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Reinsberg
authors.forename: E
authors.initials: E
authors.lastname: Jost
authors.forename: H
authors.initials: H
authors.lastname: van der Ven
mesh_terms: D001331:Automation; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D011374:Progesterone / Q000097:blood*; D011863:Radioimmunoassay / Q000295:instrumentation*; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D011374:Progesterone