NOVA Test® SARS-CoV-2 Antigen Home Test Kit
Manufactured by Atlas Link Technology Co. Ltd., China - http://www.atlas-link.com/english/
Device identification number
2956
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
Anterior nasal 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, 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
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NOVA Test®SARS-CoV-2 Antigen Home Test Kit is intended for detection of SARS-CoV-2 Virus (COVID-19 Virus) for self-testing at home or near patient circumstance when someone was suspected COVID-19 infection within the first 7 days after symptom onset and non-symptomatic population especially for those who have recently been in contact with suspected or positive patients. This kit uses a nasal swab sample to reduce discomfort which can be applied to any person ranging from age 18 to 70. Adolescents or children can be tested under adult supervision or tested by an adult. For infants, very young children, or adults older than 70 please consult with your physician before use.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
50 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % Compared with PCR test, 419 individuals, 0 false positive
False negatives
0.81 % (Compared with PCR test, 123 individuals, 1 false negative)
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