Performance assessment of Respiratory Viral ELITe MGB(R) assay for the quantitative detection of influenza A/B and respiratory syncytial viruses

Piralla, A.; Giardina, F.; Fratini, A.; Sapia, D.; Rovida, F.; Baldanti, F.

doi:10.1101/2020.05.14.097303

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bioRxiv · 10.1101/2020.05.14.097303

Performance assessment of Respiratory Viral ELITe MGB(R) assay for the quantitative detection of influenza A/B and respiratory syncytial viruses

Piralla, A.·Giardina, F.·Fratini, A.·Sapia, D.·Rovida, F.·Baldanti, F.

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Abstract

Influenza (Flu) and respiratory syncytial virus (RSV) are responsible for lower respiratory tract infections (LRTIs) associated with significant hospitalization among young children. In the present study, the performances of a triplex PCR assay detecting Flu A/B and RSV were compared with our in-house single-plex assays using 160 stored respiratory specimens previously tested using a panel of laboratory-developed real-time RT-PCR. Of them, 61 were positive for FluA, 41 for FluB, and 58 for RSV. All samples were retrospectively quantified with Respiratory Viral (RV) ELITe MGB(R) Panel (ELITechGroup Molecular Diagnostics, Puteaux, France) processed using ELITe InGenius(R) system. Overall, the total percentage agreement observed was 93.4% (57/61) for FluA, 92.7% (38/41) for FluB, and 86.2% (50/58) for RSV. A significant correlation of VL values was observed between the two methods for FluA and RSV ({rho}= 0.91 and 0.84). This finding was supported by the strength of agreement between the two methods, as showed by the linear regression analysis (R2 =0.84 and 0.80). FluB viral load values measured by RV Panel were less significantly correlated ({rho}= 0.77 and R2 =0.56). The bland-Altman analysis showed how 84.2% (48/57) of FluA and 86.0% of RSV (43/50) samples fell within {+/-}1.0 Log10 variation from our laboratory results, while only 21.1% (8/38) of FluB results fell within this range. The great majority of FluB samples (29/30) outside range had values higher than +1.0 Log10 (median +2.1 Log10 range +1.0 to +3.5 Log10). In conclusion, RV ELITe MGB(R) Panel constitutes a valid and robust system for simultaneous detection and quantification of Flu A/B and RSV.

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Piralla, A., Giardina, F., Fratini, A., Sapia, D., Rovida, F., Baldanti, F.. 2020-05-16. Performance assessment of Respiratory Viral ELITe MGB(R) assay for the quantitative detection of influenza A/B and respiratory syncytial viruses. https://doi.org/10.1101/2020.05.14.097303

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