STANDARD™ M10 FLU/RSV/SARS2 FAST
Product Information
STANDARD™ M10 Flu/RSV/SARS-CoV-2 Fast is a molecular in vitro diagnostic assay that aids in the simultaneous detection and identification of Influenza A, Influenza B, RSV, and SARS-CoV-2 viral RNA based on nucleic acid amplification technology, real-time RT-PCR. STANDARD M10 Flu/RSV/SARS-CoV-2 Fast is an all-in-one cartridge containing nucleic acid extraction and amplification reagents, which simplifies the testing process and allows users to obtain results within 36 minutes.
| Product name | STANDARD™ M10 FLU/RSV/SARS2 FAST |
| Cat-Nr. | 11FLU30A |
| Sensitivity | Influenza A: 100.00% (148/148) [95% CI: 97.47% - 100.00%], Influenza B: 98.78% (81/82) [95% CI: 93.41% - 99.78%], RSV: 97.96% (96/98) [95% CI: 92.86% - 99.44%], SARS-CoV-2: 98.51% (132/134) [95% CI: 94.72% - 99.59%] |
| Sample volume | 300 µl |
| Sample type | Nasopharyngeal swab (VTM/UTM) |
| Specificity | Influenza A: 99.13% (569/574) [95% CI: 97.98% - 99.63%], Influenza B: 98.44% (630/640) [95% CI: 97.15% - 99.15%], RSV: 98.72% (616/624) [95% CI: 97.49% - 99.35%], SARS-CoV-2: 99.49% (585/588) [95% CI: 98.51% - 99.83%] |
| Tests | 10 |
| Method | Real-Time PCR |
| Note | Limit of detection: Influenza virus: Flu A H1N1 pdm (199.5 cp/ml), Flu A H1 (354.8 cp/ml), Flu A H3 (141.3 cp/ml), Flu B (0.016 TCID50/ml), RSV: RSV A (281.8 cp/ml), RSV B (104.7 cp/ml) / SARS-CoV-2: ORF1ab/E gene (263.0 cp/ml), N gene(537.0 cp/ml) |
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