Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)
Manufactured by Hoyotek Biomedical Co. Ltd., China
Device identification number 1929
CE Marking ✓Yes
HSC common list (RAT) ✓Yes
Format Manual, Near POC / POC
Physical Support Cassette
Target type Antigen
Antibody type Monoclonal
Targets nucleocapsid protein
Specimen Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested) Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Influenza A, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Pathogens detected Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Influenza A, Influenza A H3N2, Influenza B, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Rhinovirus
Lineages detected B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status Commercialised
Last Update 2022-08-24 09:08:01 CET
Comments The nasal swab model of the product has been evaluated by Braizil lab and Thai RAMA Hospital. For Braizil lab: Sensitivity 97.1%, For RAMA hospital Sensitivity 95%, specificity 100%