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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



COVID-19 Antigen Rapid Test

Manufactured by PRIMA Lab SA, Switzerland - https://primahometest.com/ 

Device identification number
2685
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Lineages detected
A.23.1 A.23.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), B.1.617.2 (Delta), P.1 (Gamma), P.2 (Zeta), P.2 (Zeta),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
COVID-19 ANTIGEN RAPID TEST was tested with the following viral strains, no cross-reaction was observed at the following concentrations: Adenovirus type 3 3.16 x 10^4 TCID50/ml Influenza B 3.16 x 10^6 TCID50/ml Adenovirus type 7 1.58 x 10^5 TCID50/ml Human Rhinovirus 2 2.81 x 10^4 TCID50/ml Human Coronavirus OC43 1 x 10^6 TCID50/ml Human Rhinovirus 14 1.58 x 10^6 TCID50/ml Human Coronavirus 229E 5 x 10^5 TICID50/ml Human Rhinovirus 16 8.89 x 10^6 TCID50/ml Human Coronavirus NL63 1 x 10^6 TICID50/ml Masern-Virus 1.58 x 10^4 TCID50/ml Human Coronavirus HKU1 1 x 10^6 TICID50/ml Mumps-Virus 1.58 x 10^4 TCID50/ml MERS COV Florida 1.17 x 10^4 TICID50/ml Parainfluenza virus 2 1.58 x 10^7 TCID50/ml Influenza A H1N1 3.16 x 10^5 TCID50/ml Parainfluenza virus 3 1.58 x 10^8 TCID50/ml Influenza A H3N2 1 x 10^5 TCID50/ml Respiratory syncytial virus 8.89 x 10^4 TCID50/ml Hangzhou Alltest Biotech CO., Ltd is the contract OEM manufacturer of COVID-19 Antigen Rapid Test which is already on the Common list of rapid antigen tests (JRC Device ID 1257).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
N.A.
Fn
N.A.
Precision
Evaluated
Accuracy
99.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.4 %
Clinical Specificity
99.9 %
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