title: Technical performance and diagnostic utility of the new Elecsys neuron-specific enolase enzyme immunoassay.
abstract: This international multicenter study was designed to evaluate the technical performance of the new double-monoclonal, single-step Elecsys neuron-specific enolase (NSE) enzyme immunoassay (EIA) and to assess its utility as a sensitive and specific test for the diagnosis of small-cell lung cancer (SCLC). Intra- and interassay coefficients of variation, determined in five control or serum specimens in six laboratories, ranged from 0.7 to 5.3 (inter-laboratory median: 1.3%) and from 1.3 to 8.5 (inter-laboratory median: 3.4%), respectively. Laboratory-to-laboratory comparability was excellent with respect to recovery and inter-assay coefficients of variation. The test was linear between 0.0 and 320 ng/ml (highest measured concentration). There was a significant correlation between NSE concentrations measured using the Elecsys NSE and the established Cobas Core NSE EIA II in all subjects (n = 723) and in patients with lung cancer (n = 333). However, NSE concentrations were systematically lower (approximately 9%) with the Elecsys NSE than with the comparison test. Based on a specificity of 95% in comparison with the group suffering from benign lung diseases (n = 183), the cut-off value for the discrimination between malignant and benign conditions was set at 21.6 ng/ml. NSE was raised in 73.4% of SCLC patients (n = 188) and was significantly higher (p < 0.01) in extensive (87.8%) as opposed to limited disease (56.7%). NSE was also elevated in 16.0% of the cases with non-small cell lung cancer (NSCLC, n = 374). It is concluded that the Elecsys NSE EIA is a reliable and accurate diagnostic procedure for the measurement of NSE in serum samples. The special merits of this new assay are the wide measuring range (according to manufacturer's declaration up to 370 ng/ml) and a short incubation time of 18 min.
authors.affiliation: Thoraxklinik-Heidelberg gGmbH, Heidelberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Muley
authors.forename: Werner
authors.initials: W
authors.lastname: Ebert
authors.forename: Petra
authors.initials: P
authors.lastname: Stieber
authors.forename: Hannelore
authors.initials: H
authors.lastname: Raith
authors.forename: Stefan
authors.initials: S
authors.lastname: Holdenrieder
authors.forename: Dorothea
authors.initials: D
authors.lastname: Nagel
authors.forename: Heinrich
authors.initials: H
authors.lastname: Fürst
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Roth
authors.forename: Hilmar
authors.initials: H
authors.lastname: Luthe
authors.forename: Bert G
authors.initials: BG
authors.lastname: Blijenberg
authors.forename: Eberhard
authors.initials: E
authors.lastname: Gurr
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Uhl
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
authors.forename: Peter
authors.initials: P
authors.lastname: Drings
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000175:diagnosis / Q000201:enzymology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D018287:Carcinoma, Large Cell / Q000097:blood / Q000175:diagnosis / Q000201:enzymology; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000175:diagnosis / Q000201:enzymology*; D018288:Carcinoma, Small Cell / Q000097:blood / Q000175:diagnosis* / Q000201:enzymology*; D002294:Carcinoma, Squamous Cell / Q000097:blood / Q000175:diagnosis / Q000201:enzymology; D016022:Case-Control Studies; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007124:Immunoenzyme Techniques; D008168:Lung / Q000201:enzymology; D008175:Lung Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000201:enzymology*; D008875:Middle Aged; D010751:Phosphopyruvate Hydratase / Q000032:analysis*; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D010751:Phosphopyruvate Hydratase