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Serum neuron specific enolase (S-NSE) reference interval evaluation by time-resolved immunofluorometry compared with
L G Jørgensen1, J Løber, N L Carlsen
1Department of Clinical Biochemistry, Gentofte University Hospital, Hellerup, Denmark.
Summary
This study evaluated the DELFIA assay for serum neuron specific enolase (S-NSE) and found it comparable to the RIA method. Both assays demonstrated high diagnostic efficacy and are considered interconvertible for clinical use.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Assay Validation
Background:
- Serum neuron specific enolase (S-NSE) is a biomarker requiring reliable measurement.
- Existing radioimmunoassay (RIA) methods for S-NSE have limitations.
- Newer assays like DELFIA need validation against established methods.
Purpose of the Study:
- To evaluate the DELFIA assay for serum neuron specific enolase (S-NSE) measurement.
- To compare the DELFIA assay with the established S-NSE RIA method.
- To determine reference intervals and diagnostic efficacy for the DELFIA assay.
Main Methods:
- 161 healthy blood donors were used to establish reference intervals for S-NSE using DELFIA.
- The DELFIA assay was compared with the S-NSE RIA assay in 110 patients.
- Statistical analysis included Box-Cox transformation, correlation, and diagnostic efficacy assessment.
Main Results:
- DELFIA assay showed lower analytical variation (CV% 3.7-6.6%) compared to RIA (CV% 7.6-13.1%).
- Established 95% reference intervals for females (2.9-9.6 µg/l) and males (3.4-11.7 µg/l).
- High correlation (r=0.99) and identical diagnostic efficacy (0.91) were found between DELFIA and RIA, with interconvertibility at low concentrations.
Conclusions:
- The DELFIA assay is a reliable and precise method for measuring serum neuron specific enolase (S-NSE).
- DELFIA and RIA methods are interconvertible for clinical use, especially for low S-NSE concentrations.
- The DELFIA assay offers improved analytical performance over the RIA method.