Real SARS-CoV-2
Manufactured by OPERON S.A., Spain - https://operondx.com/molecular-diagnostics/
Device identification number
1741
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Detection of E gene and RdRp gene (orf1ab) Storage at -20ºC, shipment at 2-8ºC
Assay Type
Nucleic acid-PCR
Subcategory
Other ()
Method
RT-PCR
Measurement
Semiquantitative
Time
70 minutes
Subclass
JRC-S
LOD
1.25 cpu
Positive control
E gene RNA, RdRp gene RNA, human GADPH gene RNA
Negative control
Human GADPH gene RNA
Analytical Sensitivity
98 %
Analytical Specificity
100 %
Clinical Sensitivity
95.3 %
Clinical Specificity
99 %
Throughput
96 samples/run
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