SARS-CoV-2/Influenza A/B/RSV Antigen Rapid Test Kit
Manufactured by Shenzhen Watmind Medical Co. Ltd., China - http://www.watmind.com
Device identification number
24740
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, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Herpes Simplex (HSV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Enterovirus68,CandidaAlbicans,CorynebacteriumSp.,EscherichiaColi,NeisseriaMeningitides,PseudomonasAeruginosa,StaphylococcusAureus,StaphylococcusEpidermidis,StreptococcusPneumoniae,StreptococcusPyogenes,StreptococcusSalivarius,Measles,PneumocystisJirovecii), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV-2
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
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.1.526 (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
2023-02-23 06:19:48 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
49 TCID50/ml (SARS-CoV-2)
Calibration
Evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
% SARS-CoV-2 - Nasal/Nasopharyngeal/Oropharyngeal Swab
False negatives
7.07 % (SARS-CoV-2 - Nasal Swab)
False negatives
9.42 % (SARS-CoV-2 - Oropharyngeal Swab)
False negatives
8.26 % (SARS-CoV-2 - Nasopharyngeal Swab)
Precision
Evaluated
Accuracy
96.82 % (SARS-CoV-2 - Nasal Swab)
Accuracy
96.17 % (SARS-CoV-2 - Nasopharyngeal Swab)
Accuracy
95.61 % (SARS-CoV-2 - Oropharyngeal Swab)
Robustness
Evaluated
Clinical Sensitivity
92.93 % (SARS-CoV-2 - Nasal Swab)
Clinical Sensitivity
91.74 % (SARS-CoV-2 - Nasopharyngeal Swab)
Clinical Sensitivity
90.58 % (SARS-CoV-2 - Oropharyngeal Swab)
Clinical Specificity
100 % (SARS-CoV-2/Influenza A/Influenza B/RSV)
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