Performance Evaluation of Molecular Detection of Enteroviruses: Results of 18 Years of Quality Control for Molecular Diagnostics (QCMD) External Quality Assessment Program, 2005-2022.

The gold standard for enterovirus (EV) detection is the polymerase chain reaction based on the detection of the 5' untranslated region of the virus. Correct detection of EV is crucial for patient and public health purposes. The performance of diagnostic and public health laboratories on molecular EV-detection was analyzed using data from the external quality assessment program distributed by Quality Control for Molecular Diagnostics (QCMD) between 2005 and 2022. Overall performance on core samples of both laboratory types has improved over the years for in-house or commercial assays (overall performance rate > 94.8%) since 2013. A similar improvement was observed for negative/specificity samples. Performance on EV-positive samples varied, with the lowest performance observed on samples containing enterovirus D68 (B3 strain) and echovirus 11. Significant differences in performance were observed between laboratory and assay types. Performance of diagnostic laboratories (91.8) was significantly higher than of public health laboratories (89.9%; p < 0.0001). Additionally, a significant higher performance of diagnostic laboratories using commercial assays was observed (92.5% vs. 91.2% for in-house assays; p < 0.0001). In contrast, the performance of public health laboratories using in-house assays (90.1%) was higher than commercial assays (89.2%; p = 0.3608). The data document the improved performance of diagnostic and public health laboratories using either commercial or in-house assays.