Background:
The Ciba Corning estradiol procedure was a competitive chemiluminescence immunoassay using a acridinium ester (AE)-labeled mouse monoclonal antibody (Lite agent) and paramagnetic particles (Soled phase) and changes in chemiluminescence are
measured,
and requiring only 15 minutes for its performance with no addtional room temperature incubation.
Methods:
We evaluated the analytical performance of the Ciba Corning ACS : 180TM for estradiol(E2). The characteristics evaluated were; imprecision study, linearity trest, recovery rate, carryover (sample-to-sample & reagent-related), determination of
detection limit, and comparison with radioimmunoassy (RIA).
Results:
The CVs of imprecision study for the three control sera were below 9% in the within-run and between-run precision. The range of linearity (up to 2,000 pg/ml) was acceptible. The recovery rate was 102.3±6.0%. Correlation and regression with
RIAs
were as follows: CIA=0.777×RIA-1+16.747, R=0.902; CIA=0.951×RIA-2+5.952, R=0.910. Correlation and regression between RIA s was RIA-1=1.193×RIA-2-12.308, R=0.983. Neither sample- nor reagent-carryover was found. The lower limit of detection is
3.64
pg/ml.
Conclusions:
The ACS : 180TM for E2 is rapid, precise, and performance capabilities as an alternative to RRIA. Significant difference were found between laboratories within the E2 results. These results suggest that E2 level should be interpreted with
caution
across laboratories. So quality control between laboratories were needed in the determination of E2.
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