Performance Evaluation of a Newly Developed Chemiluminescent Assay Kit for Detection of Neuron-Specific Eno
| Autor: | Luo Qing, Yan Shui-Di, Weng Zu-Xing, Jin Hong-Wei, Zhang Zhong-Ying, Lin Yan-Ling, Liu Jiang-Wu, Chen Yi-Juan, Li Hong-Wei, Lin Yong-Zhi, Ye Hui-Ming, Yu Yang, Ye Chun-Lei, Lin Zhi-Yuan |
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| Rok vydání: | 2018 |
| Předmět: |
Detection limit
Chromatography Chemistry Reproducibility of Results Guidelines as Topic Quantitative accuracy General Biochemistry Genetics and Molecular Biology law.invention Linear range Recovery rate Method comparison law Limit of Detection Reagent Phosphopyruvate Hydratase Luminescent Measurements Humans Reagent Kits Diagnostic Chemiluminescence |
| Zdroj: | Clinical laboratory. 64(7) |
| ISSN: | 1433-6510 |
| Popis: | Background To evaluate the performance of a chemiluminescence detection reagent for Neuron-specific enolase (NSE). Methods Based on the "Guiding principles on performance analysis of diagnostic, reagents in vitro" and the Clinical and Laboratory Standards Institute (CLSI) Guidelines, performance of the CLIA NSE kit was evaluated, including the detection limit, linear range, reportable range, accuracy, precision, cross reactivity, interference factors, Hook effect, and method comparison. Results The detection limit of the reagent was 0.05 ng/mL. The linear range of the reagent was 0.05 ng/mL - 400 ng/mL. The reagent can be reported as 0.05 ng/mL - 2,500 ng/mL. The recovery rate ranged from 94.95% to 105.12%. The CV of the reagent of the intra-assay was 3.8% - 5.7% and inter-batch was 3.6%, which meets the requirements. The common interference factors such as the blood fat, jaundice, and rheumatoid factor did not affect the quantitative accuracy of the reagent, but hemolysis resulted in higher readings. Cross-reactions were not observed when incubating with major interfering tumor markers; therefore, the kit was highly specific for NSE. The HOOK effect was not observed when the NSE content reached 20,000 ng/mL in samples. The coincidence rate of the reagent and Roche's products reached 94.81% and the correlation r reached 0.968. Conclusions The performance of the NSE CLIA reagent was acceptable in all evaluated parameters, meeting requirements for clinical application. |
| Databáze: | OpenAIRE |
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