1S Détection Expert
Manufactured by GeneStore France SAS, France - https://www.genestore.org/
Device identification number
2772
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasal aspirate, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The kit can be used directly on samples without extraction. This lowers the overall diagnostic time and reduces the probability of cross contamination.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
60 minutes
LOD
100 %
Positive control
nCoVPC N1+N2
Negative control
Nuclease free water
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