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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold)

Manufactured by Hoyotek Biomedical Co. Ltd., China - http://hoyotek.cn/ 

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%
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
13 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
200 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % (Nasopharyngeal swab/Antigen)
False positives
2.5 % (Oropharyngea swab/Antigen)
False positives
5.45 % (Nasal swab)
False negatives
0.21 % (Nasal swab)
False negatives
4 % (Nasopharyngeal swab/Antigen)
False negatives
7 % (Oropharyngea swab/Antigen)
Precision
Evaluated
Accuracy
94.8 % (Oropharyngea swab/Antigen)
Accuracy
98.4 % (Nasopharyngeal swab/Antigen)
Accuracy
98.79 % (Nasal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % (Nasopharyngeal swab)
Clinical Sensitivity
94.55 % (Nasal swab)
Clinical Sensitivity
93 % (Oropharyngea swab)
Clinical Specificity
99 % (Nasopharyngeal swab)
Clinical Specificity
97.5 % (Oropharyngea swab)
Clinical Specificity
99.79 % (Nasal swab)
Type of antigen
Nucleocapsid protein, Other
Notes
antigen_epi: 45-181aa. Other pathogens tested for cross-reactivity: MERS-coronavirus,Adenovirus 71,Human Metapneumovirus,Enterovirus,RStreptococcus pneumoniae,espiratory syncytial virus A,Rhinovirus,Haemophilus influenza,Streptococcus pneumoniae

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