Analytical and clinical evaluation of an electrochemiluminescence immunoassay for the determination of CA 125
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- Huub E van Ingen
- Department of Clinical Chemistry, AZR Daniel den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands
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- Daniel W Chan
- Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD 21205
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- Walter Hubl
- Institut für Klinische Chemie, Krankenhaus Dresden Friedrichstadt, D-1067 Dresden, Germany
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- Hayato Miyachi
- Department of Clinical Pathology, Toukai University School of Medicine, Isehara, Japan
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- Rafael Molina
- Unitat de Recerca del Cancer, Hospital Clinic I Provincial, Barcelona E-08034, Spain
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- Lutz Pitzel
- Abteilung für Klinische und Experimentelle Endokrinologie, Frauenklinik, Georg-August-Universitaet Goettingen, D-37075 Goettingen, Germany
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- Alvaro Ruibal
- Centro de Patologia de la Mama, E-28003 Madrid, Spain
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- Jean C Rymer
- Laboratoire Central de Biochimie, Hopital Henri Mondor, Creteil Cedex F-94010, France
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- Ingrid Domke
- Boehringer Mannheim GmbH, D-68305 Mannheim, Germany
説明
<jats:title>Abstract</jats:title> <jats:p>The CA 125 II assay on the Elecsys® 2010 analyzer was evaluated in an international multicenter trial. Imprecision studies yielded within-run CVs of 0.8–3.3% and between-day CVs of 2.4–10.9%; CVs for total imprecision in the manufacturer’s laboratory were 2.4–7.8%. The linear range of the assay extended to at least 4500 kilounits/L (three decades). Interference from triglycerides (10.3 mmol/L), bilirubin (850 μmol/L), hemoglobin (1.1 mmol/L), anticoagulants (plasma), and several widely used drugs was undetectable. Method comparisons with five other CA 125 II assays showed good correlation but differences in standardization. A 95th percentile cutoff value of 35 kilounits/L was calculated from values measured in 593 apparently healthy (pre- and postmenopausal) women. In 95% of patients with benign gynecological diseases CA 125 was ≤190 kilounits/L; 63% of patients with newly diagnosed ovarian carcinoma had values >190 kilounits/L. A comparison of CA 125 values obtained with the Elecsys test and with other common CA 125 tests in monitored patients being treated for ovarian cancer showed identical patterns. In conclusion, the Elecsys CA 125 II assay is linear over a broad range, yields precise and accurate results, is free from interferences, and compares well with other assays.</jats:p>
収録刊行物
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- Clinical Chemistry
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Clinical Chemistry 44 (12), 2530-2536, 1998-12-01
Oxford University Press (OUP)
