Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Rapid Test Ag 2019-nCov

Manufactured by Prognosis Biotech, Greece - https://www.prognosis-biotech.com 

Device identification number
1495
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Dipstick, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza B
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Additional information provided upon request
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
358.75 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.26 % (1/385 - Nasal specimen )
Fp
0.42 % (2/478 - Nasopharyngeal specimen)
Fn
1.41 % (2/142 - Nasal specimen )
Fn
4.44 % (6/135 - Nasopharyngeal specimen)
Precision
Evaluated
Accuracy
98.7 % (Nasopharyngeal specimen)
Accuracy
99.43 % (Nasal specimen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.59 % (Nasal specimen)
Clinical Sensitivity
95.56 % (Nasopharyngeal specimen)
Clinical Specificity
99.74 (Nasal specimen)
Clinical Specificity
99.58 % (Nasopharyngeal specimen)
Type of antigen
Nucleocapsid 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