Two-center clinical evaluation of a new automated fluorometric immunoassay for the quantitative analysis of total betaeta-human chorionic gonadotropin.

摘要

This study evaluated the quantitative total betahCG assay on the Stratus(R) CS point-of-care instrument at two medical centers.Analytical sensitivity, linearity, within-run and total imprecision, interferences, dilution recovery, method comparison (Dimension(R) RxL), comparison of matched heparinized whole blood and plasma samples, and determination of the normal reference interval were studied.Analytical sensitivity was <0.5 IU/L. The assay's linear range was 0 to 1250 IU/L; the clinical reportable range was up to 50,000 IU/L. Within-run imprecision (CV) at both low (<20 IU/L) and elevated (760 IU/L) betahCG concentrations were <4%. Total imprecision for three QC levels and two pools were <4%. Method comparison showed Stratus CS betahCG = 0.98 +/- 0.01* Dimension RxL hCG -0.11 +/- 2.69 (n = 136; r = 0.996; Sy/x = 27.7). Matched heparinized whole blood/plasma sample-comparison showed: whole blood = 1.05*Plasma + 0.37 +/- 1.29 (n = 41; r = 1.000; Sy/x = 7.57). Mean dilution recovery was 99% (range: 95% to 103%). None of the 52 drugs tested, lipemia, icterus, hemolysis, LH, FSH, TSH, hGH or prolactin represented a significant interference with the assay. Reference intervals were <0.5 IU/L for males (n = 123) and <3.0 IU/L for nonpregnant females (n = 120).The Stratus(R) CS betahCG test offers the advantage of quantitative measurement of total betahCG in whole blood at the point of care and is suitable for clinical use.