Detection Expert 1S © SARS CoV-2 kit
Manufactured by GeneStore France SAS, France - https://www.genestore.org/
Device identification number
2699
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Specimen
Bronchoalveolar lavage fluid, Deep (cough) sputum, Nasal aspirate, Nasal aspiration, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
GeneStore France's Detection Expert 1S © SARS CoV-2 kit, allows for a fast qualitative analysis of the presence of SARS-CoV-2 in samples direct-to-PCR, without the need of performing prior extraction of viral RNA.
Assay Type
Unknown
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
60 minutes
LOD
100 %
Positive control
nCoVPC N1+N2
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical 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