ImmTek COVID-19 Antigen Rapid Test
Manufactured by Metas Biomedical Inc., Taiwan ROC - www.metasbiomedical.com
Device identification number
1928
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Dipstick, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.526 (Iota), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Prefilled buffer can inactivate coronavirus to avoid cross contamination.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
313 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.46 AU
False negatives
4.72 AU
Precision
Evaluated
Accuracy
98.14 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.28 %
Clinical Specificity
99.54 %
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