Real SARS-CoV-2/Flu/RSV
Manufactured by OPERON S.A., Spain - https://operondx.com/molecular-diagnostics/
Device identification number
3145
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Nucleic acid
Targets
envelope protein/gene
Specimen
Nasal aspirate, Nasal swab, 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), Hemophilus Influenzae, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Rhinovirus
Pathogens detected
Influenza A, Influenza B, Respiratory Syncytial V (RSV), 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
Possibility of using lysis step instead of RNA extraction, lysis buffer included in the kit
Assay Type
Nucleic acid-PCR
Self Test
No
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Semiquantitative
Time
70 minutes
LOD
6.25 cpu
Positive control
SARS-CoV-2, Flu, RSV human GADPH
Negative control
human GADPH
Clinical Sensitivity
99.4 %
Clinical Specificity
99.3 %
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