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- W4387081617 abstract "Abstract Background Accurate and efficient molecular testing of viral meningitis/encephalitis is crucial for proper patient care. Here we describe the clinical evaluation of the GenomEra® HSV-1/2, VZV + EV Assay Kit (Uniogen, Finland) allowing simultaneous detection of four key viruses responsible for causing meningitis/encephalitis, namely HSV-1 and HSV-2, VZV, and enteroviruses. Methods The study was carried out at three European institutions in 2022, with a total of 193 frozen, anonymized leftover cerebrospinal fluid (CSF) specimens analyzed retrospectively. For the GenomEra HSV-1/2, VZV + EV Assay Kit, 50 µL of CSF was mixed with lysis buffer in a 1:1 ratio, allowed to incubate for 1 min at room temperature, and then filtered by a 1-min centrifugation through an Extraction Column utilizing size-exclusion chromatography. A 35-µL sample of the flow-through was applied into the Test Chip and analyzed using the GenomEra CDX System. The cotemporally performed comparison tests included the FilmArray Meningitis/Encephalitis (ME) panel (bioMérieux), Xpert® EV Assay (Cepheid), artus VZV assay (Qiagen), and a well-established, validated non-commercial real-time RT-PCR assay for the detection of HSV-1/2, VZV, and EV. Results The GenomEra HSV-1/2, VZV + EV Assay Kit produced results in 70 min with a sensitivity and specificity of 92.2% (95% CI: 82.7–97.4%) and 99.9% (95% CI: 99.2–100%), respectively, as compared to the reference tests. Of the discordant results, five tested negative with the GenomEra assay, whereas the reference tests produced low positive results (Ct values ≥ 35). In addition, one specimen yielded a positive signal for VZV while remaining negative with the reference tests. Conclusion The GenomEra HSV-1/2, VZV + EV Assay Kit showed a high overall specificity and a high level of sensitivity particularly for herpes simplex and varicella-zoster viruses. For enteroviruses, while the specificity reached 100%, the sensitivity was not as high as with the reference methods. The high clinical performance, together with the simple sample preparation protocol and short turnaround time make the GenomEra assay a competitive molecular test especially for small and medium-sized laboratories that may not have a specialist in molecular biology. In addition, the GenomEra assay only requires a small amount of sample, conserving the valuable specimens for additional testing." @default.
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- W4387081617 date "2023-09-27" @default.
- W4387081617 modified "2023-10-03" @default.
- W4387081617 title "A-250 Rapid molecular Identification of Herpes Simplex, Varicella-zoster, and Enteroviruses from Cerebrospinal Fluid" @default.
- W4387081617 doi "https://doi.org/10.1093/clinchem/hvad097.221" @default.
- W4387081617 hasPublicationYear "2023" @default.
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