SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)
Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., China - http://www.hongweitest.com
Device identification number
2585
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B,
Lineages detected
Commercial Status
Commercialised
Last Update
2021-08-30 03:57:50 CET
Comments
This product has obtained CE certification and passed the French self-test whitelist
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.7 % (Nasopharyngeal swab)
Fp
0.55 % (Saliva)
Fp
0.51 % (Oropharyngeal swab)
Fp
0.81 % (Nasal swab)
Fn
3.15 % (Oropharyngeal swab)
Fn
2.54 % (Saliva)
Fn
10 % (Nasal swab)
Fn
10.94 % (Nasopharyngeal swab)
Precision
Evaluated
Accuracy
94.44 % (Nasopharyngeal swab)
Accuracy
98.46 % (Saliva)
Accuracy
94.3 % (Nasal swab)
Accuracy
98.67 % (Oropharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.06 % (Nasopharyngeal swab)
Clinical Sensitivity
97.46 % (Saliva)
Clinical Sensitivity
96.85 % (Oropharyngeal swab)
Clinical Sensitivity
90 % (Nasal swab)
Clinical Specificity
99.45 % (Saliva)
Clinical Specificity
99.3 % (Nasopharyngeal swab)
Clinical Specificity
99.49 % (Oropharyngeal swab)
Clinical Specificity
99.19 % (Nasal swab)
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