SARS-COV-2 REALTIME PCR KIT
Manufactured by Vircell s.l., Spain - www.vircell.com/
Device identification number
426
CE Marking
×No
HSC common list (RAT)
×No
Format
Automated
Physical Support
Other (Vials)
Target type
Nucleic acid, RNA
Targets
envelope protein/gene, nucleocapsid protein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Legionella pneumophila, Streptococcus pneumoniae, Streptococcus pyogenes, Candida albicans, Pseudomonas aeruginosa, Staphylococcus epidermis)
Pathogens detected
SARS-CoV, SARS-CoV-2
Lineages detected
Other (SARS-CoV-2(100,100))
Commercial Status
Commercialised
Last Update
2022-10-06 08:43:35 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Self Test
No
Reader Required
Yes
Subcategory
Other (Diagnostic kit)
Method
RT-PCR
Measurement
Qualitative
Time
90 minutes
Subclass
Multiple
Detection Principle
Fluorescence
LOD
50 copies/tube
Analytical Sensitivity
100 %
Analytical Specificity
100 %
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