Savanna RVP-4 panel assay
Manufactured by Quidel Coorporation, United States - www.quidel.com
Device identification number
2903
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Fully automated (robot), Near POC / POC
Physical Support
Cartridge
Target type
Nucleic acid
Targets
non-structural protein/gene NSP13, ORF1ab polyprotein/gene
Specimen
Mid-turbinates swab, Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Ready to use test cassette for specific detection of Flu A, Flu B, RSV and SARS CoV-2 for use with Savanna Analyzer LOD for additional targets of the panel: 5.01E+00 (Flu A H1N1), 4.63E+00 (Flu A H2N3), 3.80E+01 (Flu B Yamagata), 4.70E+01 (Flu B Victoria), 4.17E-01 (RSV A), 5.01E-01 (RSV B) Clinical Sensitivity for additional targets of the panel 99.7% (Flu A); 97.2% (Flu B), 100% (RSV) Clinical Specificity for additional targets of the panel 99.8% (Flu A); 100% (Flu B), 99.7% (RSV)
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
RT-PCR
Measurement
Semiquantitative
Time
22 minutes
LOD
9.55 TCID50/ml (in TCID-50 / ml: 9.55E+00 for SARS CoV-2)
Positive control
Internal Process Control (IPC) included
Negative control
not included (not needed due to closed system process)
Clinical Sensitivity
95.1 %
Clinical Specificity
99.6 %
Throughput
single cartige
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements