NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Manufactured by Atlas Link Technology Co. Ltd., China - http://www.atlas-link.com/english/
Device identification number
2010
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
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, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, 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), Rhinovirus, Rhinovirus A, Rhinovirus B
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, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, 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), Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NOVA Test®SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) is an immunochromatographic membrane assay that uses the double-antibody sandwich method to detect the novel coronavirus (SARS-CoV-2) nucleocapsid protein from Nasopharyngeal swab (NPS) and Oropharyngeal swab (OP swab) from patients who are suspected of COVID-19 by a healthcare provider. Performance of the test is limited to professional use.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
50 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Compared with PCR test, 419 individuals, 0 false positives
False negatives
0.81 % (Compared with PCR test, 123 individuals, 1 false negative)
Precision
Not evaluated
Accuracy
99.8 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
99.2 %
Clinical Specificity
100 %
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