SARS-CoV-2 Antigen Test(nasopharyngeal swab)
Manufactured by Hangzhou Tongzhou Biotechnology Co Ltd, China - www.tongzhoubio.com
Device identification number
24766
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
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), Hepatitis C Virus (HCV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, MERS-CoV, Mumps Virus (MuV), 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 A H5N1, 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
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), Other (), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2023-07-27 10:46:07 CET
Comments
The SARS-CoV-2 Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasopharyngeal swab specimens.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen.
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 coinfection with other viruses. The agent detected may not be the definite cause of
disease.
Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions including infection control decisions.
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.
Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
N.A.
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Immunofluorescence
LOD
100 TCID50/ml
Calibration
Evaluated
Analytical Sensitivity
93.4 %
Analytical Specificity
99.3 %
Analysis of cross reactivity
Evaluated
False positives
0.066 AU
False negatives
0.007 AU
Precision
Evaluated
Accuracy
98.1 %
Robustness
Evaluated
Clinical Sensitivity
93.4 %
Clinical Specificity
99.3 %
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