2019 Volume 68 Issue 3 Pages 564-569
Neuron-specific enolase (NSE) has been characterized as a marker of lung small cell carcinoma or neuroblastoma. To meet clinical demands, we decided to start measuring NSE in-house instead of outsourcing the measurement. In this study, we evaluated the basic performances of the ECLusys® reagent NSE for in-house testing. We collected serum samples from patients (n = 69) and healthy volunteers (n = 5) and analyzed them using the ECLusys® reagent NSE in cobas® 8000 (Roche Diagnostics). We assessed the intra-assay precision, between-day precision, dilution linearity, correlation between outsourcing and in-house measurements, inhibition by interfering substances (rheumatoid factor, bilirubin, hemoglobin, chyle) and stability after serum collection. We also investigated the impact of sample transfer between test tubes. We observed the excellent basic performance of measurement using NSE in terms of intra-assay precision, between-day precision, dilution linearity, and correlation between outsourcing and in-house measurements. The test results showed that the NSE levels were increased by the addition of hemoglobin in a dose-dependent manner. We also found that the NSE levels decreased during refrigerated storage in a time-dependent manner. These results suggest that the refrigerated storage of the serum samples for more than two days is not appropriate for NSE determination and leads to false reports owing to the pre-examination process before measurement.