Performance Evaluation of Neuron-Specific Enolase Detection by Chemiluminescent Microparticle Immunoassay Using Alinity i Systems and Electrochemiluminescence Immunoassay Using Cobas e801 Analyzer
Keywords:
Chemiluminescent microparticle immunoassay, Electrochemiluminescence immunoassay, Immunoassay, Neuron-specific enolaseAbstract
Neuron-specific enolase (NSE) is a tumor marker that has been used to support the diagnosis, monitoring and prognosis of small cell lung cancer. In the past, NSE determination was narrowly assessed due to the complicated assay platform and lesser availability. Currently, chemiluminescent microparticle immunoassay (CMIA) for detection of NSE has been adopted by Abbott, Alinity i platform. This study focused on comparing NSE quantitative assay between Abbott Alinity i systems and Roche Elecsys NSE assay using Cobas e801. The results showed that within-run precision (%CV) of Cobas e801 ranged from 0.9 to 1.0, whereas Alinity i ranged from 1.71 to 2.76. The within-laboratory precision (%CV) of Cobas e801 was from 2.03 to 2.11%, whereas Alinity i was from 1.89 to 2.86%. Although the imprecision demonstrated that Cobas e801 had a little better performance than Alinity i, Passing and Bablok regression revealed the slope at 0.96 and intercept at -2.02, indicating a good correlation between Alinity i and Cobas e801. The percentage of agreement between these analyzers was 98.65% positive agreement and 90.91% negative agreement. These results, therefore, verified acceptable performance of these two assays and could be interchangeable for NSE measurement.
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