SARS-CoV-2 POC
Manufactured by Enbiotech s.r.l, Italy - www.icgene@com
Device identification number
3006
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Strip
Target type
Nucleic acid
Targets
nucleocapsid protein/gene, spike protein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
More of analytical specificity test have been tested in silico analysis
Assay Type
Nucleic acid-Other
Self Test
No
Reader Required
Yes
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
60 minutes
LOD
50 cpr
Positive control
Dried plasmid DNA with the target sequences
Negative control
Extraction Buffer
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
95 %
Clinical Specificity
98 %
Throughput
48 samples per 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