scholarly journals Technical Performance and Diagnostic Utility of the New Elecsys® Neuron-Specific Enolase Enzyme Immunoassay

Author(s):  
Thomas Muley ◽  
Werner Ebert ◽  
Petra Stieber ◽  
Hannelore Raith ◽  
Stefan Holdenrieder ◽  
...  
Tumor Biology ◽  
1993 ◽  
Vol 14 (5) ◽  
pp. 261-270 ◽  
Author(s):  
Takashi Aoki ◽  
Masaya Kimura ◽  
Mitsuhiro Kaneta ◽  
Hiroe Kazama ◽  
Junji Morikawa ◽  
...  

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 278-278
Author(s):  
Rahul Raj Aggarwal ◽  
Li Zhang ◽  
Tomasz M. Beer ◽  
Jack Youngren ◽  
Alise Stromlund ◽  
...  

278 Background: Detection of t-SCNC in mCRPC patients relies primarily on histopathologic evaluation (Histo) of a metastatic tumor biopsy (bx), likely leading to underdiagnosis. The clinical features of t-SCNC and the diagnostic utility of serum NE markers (neuron-specific enolase (NSE) and chromogranin (CGA)) were evaluated. Methods: Eligible patients (pts) underwent a metastatic bx at one of 5 centers. Histo was performed by 3 independent pathologists (JH, GT, LT). NE markers were evaluated in a central lab (lower limit = 1 ng/mL). Kruskal-Wallis and chi-square test were used to compare continuous and categorical variables, respectively. Receiver-operative-curve (ROC) analysis of serum NE markers was undertaken. Results: 160 consecutive pts with available Histo and NE markers were included. t-SCNC was found in 27 pts (17%). Detection of t-SCNC was observed in all bx sites, including liver (14%), lymph node (19%) and bone (14%). Clinical features are shown in the Table. By ROC analysis, if both serum NSE was > 6.05 ng/mL and chromogranin was > 3.1 ng/mL, the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) for the detection of t-SCNC were 95%, 50%, 98%, and 22%, respectively. Conclusions: Many of the classic features of de novo SCNC, including low PSA levels, do not reliably distinguish t-SCNC. In contrast, serum NE markers have diagnostic utility with high sensitivity and NPV, but low specificity and PPV. Heterogeneous NE differentiation may partially account for these findings. Clinical trial information: NCT02432001. [Table: see text]


2014 ◽  
Vol 6 (7) ◽  
pp. 2233-2238 ◽  
Author(s):  
Xiaohong Fu ◽  
Xueru Feng ◽  
Kun Xu ◽  
Rong Huang

A portable and quantitative enzyme immunoassay with a glucometer readout was developed for the sensitive monitoring of neuron-specific enolase (NSE, as a model analyte) in a high-binding polystyrene 96-well microtiter plate (MTP), conjugated with monoclonal mouse anti-human NSE antibody (mAb1).


1992 ◽  
Vol 38 (8) ◽  
pp. 1466-1471 ◽  
Author(s):  
P Kenemans ◽  
G G Bon ◽  
A C Kessler ◽  
A A Verstraeten ◽  
G J van Kamp

Abstract The technical performance and clinical usefulness of the newly developed Enzymun-Test CA 125 (Boehringer Mannheim) was evaluated in a multicenter study. Sera tested were obtained from healthy control subjects (n = 1003) and from patients with benign conditions (379), ovarian cancer (518), or other malignancies (479). Intra- and interassay variability was low at CA 125 concentrations greater than 100 units/mL. Intra- and interassay CVs were respectively less than or equal to 36% and 23% for the low CA 125 concentrations (less than or equal to 35 units/mL) and less than or equal to 15% and 14% for the medium CA 125 concentrations (36- less than or equal to 100 units/mL). Interlaboratory reproducibility of the Enzymun-Test CA 125 was excellent. A strong linear correlation was observed between Enzymun-Test CA 125 and three of four other commercially available assays of CA 125 in serum. Cutoff values of 35 units/mL in three of these other tests corresponded to Enzymun-Test CA 125 values ranging from 27.0 to 42.1 units/mL. In the fourth test, an enzyme immunoassay, a cutoff of 35 units/mL corresponded to Enzymun-Test values ranging from 64.1 to 77.0 units/mL. Discordant, as yet unexplained, results in which Enzymun-Test values were greater than 65 units/mL and Centocor CA 125 immunoradiometric assay results were less than 35 units/mL were found in 15 of 1003 samples (1.5%) of apparently healthy control subjects. Sensitivity and performance of the Enzymun-Test were very similar to those of the Centocor assay for sera from the patients with various benign disorders or malignant diseases. Given its excellent automated technical performance, this new CA 125 serum assay is feasible for monitoring ovarian cancer patients. Test results are interchangeable with those from other laboratories and, in general, with those obtained by most other CA 125 tests.


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