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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method) (self-test)

Manufactured by Zybio Inc., China - https://www.zybio.com/en/ 

Device identification number
2987
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B Victoria, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), SARS-CoV
Lineages detected
B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
This test is CE-marked under Annex III (Section 6) to Directive 98/79/EC as evidenced by the audit conducted by the PCBC, issued with EC Certificate No. 1434-IVDD-018/2022.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
70 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.96 %
Fn
11.22 %
Precision
Evaluated
Accuracy
96.947 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
88.785 % (Overall sensitivity)
Clinical Sensitivity
97.78 % (with CT≤31)
Clinical Specificity
99.041 %
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