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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 Professional Rapid Test

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

Device identification number
2686
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B, MERS-CoV, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-22 01:55:49 CET
Comments
COVID-19 Antigen Professional Rapid Test was tested with the following viral strains, no cross-reaction was observed at the following concentrations: - MERS 1.17x10^5 TCID50/mL - NL63 4.68x10^4 TCID50/mL - OC43 5.01x10^5 TCID50/mL - 229E 1.41x10^5 TCID50/mL - Adenovirus 7A (species B) 1.02x10^8 TCID50/mL - Parainfluenza Virus Type 1 9.12x10^8 TCID50/mL - Parainfluenza Virus Type 2 4.17x10^5 TCID50/mL - Parainfluenza Virus Type 3 2.57x10^8 TCID50/mL - Parainfluenza Virus Type 4 1.41x10^5 TCID50/mL - Rhinovirus 1A 1.70x10^5 TCID50/mL - Influenza A H1N1 New Caledonia/20/99 4.17x10^5 TCID50/mL - Influenza B Florida/02/06 4.68x10^4 TCID50/mL - Respiratory Syncytial Virus Type B (RSV-B) CH93-18(18) 1.55x10^4 TCID50/mL - Enterovirus Type 71 2003 Isolate (cell line LLC-mk2) 1x10^5.86 TCID50/mL - Human Metapneuomovirus 16 (hMPV-16) Type A1 IA10-2003 3.8x10^6 TCID50/mL - Recombinant Nucleocapsid SARS-CoV (2003) 1.24 mg/mL
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
102000 TCID50/ml (600 pg/mL of recombinant nucleocapsid protein)
Crossreactivity
Evaluated
Fp
N.A.
Fn
N.A.
Precision
Evaluated
Accuracy
95.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.3 %
Clinical Specificity
100 %
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