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

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Test for Self Testing

Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com 

Device identification number
1476
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
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)
Pathogens detected
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
NTD (44-180), N-CTD, 209-232a
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-11-07 02:09:37 CET
Comments
The COVID-19 Antigen Rapid Test (Swab) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimen from symptomatic / asymptomatic individuals who are suspected of being infected with COVID-19. This test is designed for the use by layperson. A positive result indicates the presence of SARS-CoV-2. Individuals whose test results are positive should self-isolate and seek help from relevant healthcare institutions. A positive result may also be caused by bacterial infection or co-infection with other viruses. A negative result may also be infected with SARS-CoV-2. Individuals whose test results are negative continue to experience COVID-like symptoms should seek follow-up help from relevant healthcare institutions.The COVID-19 Antigen Rapid Test (Swab) only indicates a preliminary result. The confirmation of the final result should be based on the clinical diagnosis.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Immunofluorescence
LOD
100 AU (Evaluated)
Analytical Specificity
99.9 % (Evaluated)
False positives
3 %
False negatives
%
Accuracy
99.1 % (Evaluated)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % (Evaluated)

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