Genespark SARS-CoV2 Quantitative detection of SARS-CoV2 genome
Manufactured by Immunospark s.r.l., Italy - www.immunospark.com
Device identification number
1905
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Fully automated (robot), Semi-automated
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Deep (cough) sputum, Nasal swab, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Quantitative assay based on gene ORF1AB and N to applied on open systems
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
120 minutes
Subclass
JRC-S
LOD
200 copies/ml
Analytical Sensitivity
98 %
Analytical Specificity
96 %
Clinical Sensitivity
97 %
Clinical Specificity
97 %
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