PERFORMANCE OF THE FULLY AUTOMATED PROGESTERONE ASSAYS ON THE ABBOTT AXSYM(R) AND THE TECHNICON-IMMUNO-1(R) ANALYZER COMPARED WITH THE RADIOIMMUNOASSAY PROGESTERONE MAIA(R)

Objective: Test performance of two automated progesterone assays avail able on the immunoassay analysers Abbott AxSYM(R) and Technicon Immuno 1(R), respectively, was evaluated in comparison with the radioimmunoa ssay Progesterone MAIA(R) Methods: For assessment of test performance imprecision, functional sensitivity and linearity of dilution was exam ined. Correlation with the manual radioimmunoassay was assessed using 122 serum samples over the range 0-110 nmol/L. Results: Imprecision st udies 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); I mmune 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 Immune 1 Progesterone. With the AxSYM Progesterone the mean recovery after d ilution from five samples was 102% (89-107%), from one sample only 69- 80% was recovered; with the immuno 1 Progesterone the mean recovery wa s 95% (80-105%). Despite of a quite good overall correlation (coeffici ents 0.972 and 0.981) the relationship of both assays to the Progester one MAIA significantly deviate from linearity with a considerably high er slope within the lower concentration range. The relationship betwee n 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 Immune 1 Progesteron e and 90 min for the Progesterone MAIA. Conclusion: The evaluated prog esterone assays both exhibit an excellent precision and a high degree of sensitivity. They offer a rapid and flexible method for progesteron e determination which may be especially useful for the monitoring of o varian stimulation during in-vitro fertilization.