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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 (Swab)

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

Device identification number
2449
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), 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), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mumps Virus (MuV), Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)
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
44-175aa, 74-105aa
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
2022-09-20 05:34:01 CET
Comments
The COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Immunofluorescence
LOD
100 AU (Evaluated)
False positives
0.01 AU (Nasopharyngeal Swab(Antigen))
False positives
0.001 AU (Nasal Swab(Antigen))
False negatives
0.039 AU (Nasal Swab(Antigen))
False negatives
0.036 AU (Nasopharyngeal Swab(Antigen))
Accuracy
98.2 % (Nasopharyngeal Swab(Antigen))
Accuracy
98.2 % (Nasal Swab(Antigen))
Clinical Sensitivity
96.1 % (Nasal Swab(Antigen))
Clinical Sensitivity
96.4 % (Nasopharyngeal Swab(Antigen))
Clinical Specificity
99.9 % (Nasal Swab(Antigen))
Clinical Specificity
99 % (Nasopharyngeal Swab(Antigen))

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