EurobioPlex SARS-CoV-2 Fast-SVD
Manufactured by Eurobio Scientific, France - https://www.eurobio-scientific.com/
Device identification number
2867
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Nucleic acid
Targets
spike protein/gene
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 general performance: General sensitivity: > 99% (269/269) General specificity: > 99% (570/570) General concordance: > 99% (839/839) Mutations performance: K417N sensitivity: > 99% (165/165) K417N specificity: > 99% (104/104) K417N concordance: > 99% (269/269) L452R sensitivity: > 99% (91/91) L452R specificity: > 99% (178/178) L452R concordance: > 99% (269/269) E484K sensitivity : > 99% (168/168) E484K specificity : > 99% (101/101) E484K concordance : > 99% (269/269) Detection limitation/analytical sensitivity on CP: SARS-CoV-2 : 5 copies/μL K417N mutation : 5 copies/μL L452R mutation : 5 copies/μL E484K mutation : 5 copies/μL IC Cy5 : 10 copies/μL No aspecificity or cross reaction was detected. The kit is 100% specific.
Assay Type
Nucleic acid-PCR
Self Test
No
Method
RT-PCR
Measurement
Qualitative
Time
47 minutes
LOD
5 copies/μl (mutation K417N)
LOD
5 copies/μl (mutation L452R)
LOD
5 copies/μl (mutation E484K)
LOD
5 copies/μl (SARS-CoV-2 general )
LOD
10 copies/μl (IC Cy5)
Accuracy
99 % (269/269 concordance for mutation E484K)
Accuracy
99 % (269/269 concordance for mutation L452R)
Accuracy
99 % (269/269 concordance for mutation K417N)
Accuracy
99 % (839/839 Concordance for SARS-CoV-2 general )
Clinical Sensitivity
99 % (168/168 - mutation E484K)
Clinical Sensitivity
99 % (91/91 - mutation L452R)
Clinical Sensitivity
99 % (165/165 - mutation K417N)
Clinical Sensitivity
99 % (269/269 - SARS-CoV-2 general )
Clinical Specificity
99 % (104/104 - mutation K417N)
Clinical Specificity
99 % (178/178 - mutation L452R)
Clinical Specificity
99 % (101/101 - mutation E484K)
Clinical Specificity
99 % (570/570 - SARS-CoV-2 general )
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