Vivalytic SARS-CoV-2 Pooling
Manufactured by Bosch Healthcare Solutions, Germany - https://www.bosch-vivalytic.com/
Device identification number
2976
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Near POC / POC
Physical Support
Cartridge
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Comment to analytical sensitivity/specificity: ≥95% Comment to clinical sensitivity/specificity:≥97,8/95,7 - dependent on sample type
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
44 minutes
LOD
750 cpr
Positive control
whole process control including control of sample quality
Negative control
N/A
Analytical Sensitivity
95 %
Analytical Specificity
94 %
Clinical Sensitivity
97.8 %
Clinical Specificity
95.7 %
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