Technical evaluation of the Beckman Coulter OV-Monitor (CA 125 antigen) immunoassay
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Eray Yagmur
Abstract
Background: The CA 125 antigen is a large (200–1000kDa) glycoprotein, present within normal and benign ovarian tissue. We evaluated the analytical performance of the newly available Beckman Coulter OV-Monitor (CA 125 antigen) immunoassay on the Beckman Coulter UniCel™ DxI 800 analyzer.
Methods: The evaluation was performed according to NCCLS recommendations.
Results: The lowest level of CA 125 antigen detectable was 0.374U/mL. Serial dilution of two pooled CA 125 antigen-rich samples provided a linear response (p<0.0001). For total CV% the following results were obtained: pool sera, 11.7U/mL (2.70%), 56.3U/mL (2.41%), 108.43U/mL (2.31%); and QC sera, 29.4U/mL (2.57%), 101.1U/mL (3.26%). Comparison of the OV-Monitor on the UniCel™ DxI 800 showed linear regression values of r=0.961 vs. the Bayer ADVIA Centaur system and r=0.981 vs. the Abbott AxSYM system.
Conclusion: Considering the limited number of serum samples analyzed, our data indicate that the Beckman Coulter OV-Monitor immunoassay has excellent analytical performance and shows satisfactory correlation with automated immunoassays on the Abbott AxSYM and Bayer ADVIA Centaur systems. It is easy to perform, accurate and suitable for measurements in routine clinical laboratories.
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©2006 by Walter de Gruyter Berlin New York
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- Sixth International Symposium on Molecular Diagnostics, Graz, Austria, May 25-27, 2006
Artikel in diesem Heft
- Natriuretic peptides and evidence-based quality specifications
- Preanalytical variability: the dark side of the moon in laboratory testing
- Clinical relevance of biological variation: the lesson of brain natriuretic peptide (BNP) and NT-proBNP assay
- Hepatorenal syndrome
- Modified Levey-Jennings charts for calculated laboratory tests
- Increased free malondialdehyde concentrations in smokers normalise with a mixed fruit and vegetable juice concentrate: a pilot study
- The exponentially weighted moving average (EWMA) rule compared with traditionally used quality control rules
- Intermethod calibration of alanine aminotransferase (ALT) and γ-glutamyltransferase (GGT) results: application to Fibrotest® and Actitest® scores
- Comparison of TEST 1 with SRS 100 and ICSH reference method for the measurement of the length of sedimentation reaction in blood
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- Stepwise strategies in analysing haematuria and leukocyturia in screening
- Elevation of serum cerebral injury markers correlates with serum choline decline after coronary artery bypass grafting surgery
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- Physiological matrix metalloproteinase (MMP) concentrations: comparison of serum and plasma specimens
- Importance of the functional sensitivity determination of a serum hyaluronic acid assay for the prediction of liver fibrosis in patients with features of the metabolic syndrome
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