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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



KnowNow SARS-CoV-2 Rapid Antigen Test

Manufactured by Vatic Health Ltd., United Kingdom - https://www.knownow.com/ 

Device identification number
2508
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
https://aic.mhra.gov.uk/era/pdr.nsf/vwLkupFileRef/11903?opendocument
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
LOD
500 PFU/mL
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % (Diagnostic Specificity 100% (95% CI 98.6-100%)). Reference Standard RT-PCR
Fn
4.4 % ( (Diagnostic Sensitivity 95.6% (95% CI 91.1-98.2%). Reference standard was RT-PCR)
Precision
Evaluated
Accuracy
98 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.6 ( (Antigen))
Clinical Specificity
100 ( (Antigen))
Type of antigen
Spike protein

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