COVID-19/Influenza A/Influenza B Detection Kit
Manufactured by New Gene (Hangzhou) Bioengineering Co. Ltd., China - www.new-gene.net/
Device identification number
2330
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal 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, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is suitable for people with symptoms similar to COVID-19, like cough, fever, fatigue and etc., to assist the early diagnosis of SARS-CoV-2 infection, Influenza A virus infection, and Influenza B virus infection. It can also be used to test people without COVID-19 symptoms to regularly monitor their health status.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunoassay
Measurement
Qualitative
Time
30 minutes
Subclass
Sandwich
LOD
1
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.87 % (1 out of 114 (COVID-19); )
False positives
0.81 % (1 out of 123 (IFB))
False positives
0.81 % (1 out of 123 (IFA))
False negatives
2.02 % (5 out of 247 (COVID-19); )
False negatives
2.67 % (3 out of 112 (IFB))
False negatives
3.41 % (4 out of 117 (IFA))
Precision
Evaluated
Accuracy
98.3 % ((Antigen COVID-19); )
Accuracy
98.3 % ( (Antigen IFB))
Accuracy
97.9 % ( (Antigen IFA))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 % ( (Antigen COVID-19); )
Clinical Sensitivity
96.6 % ( (Antigen IFA);)
Clinical Sensitivity
97.3 % ( (Antigen IFB))
Clinical Specificity
99.2 % ((Antigen IFA);)
Clinical Specificity
99.2 % ((Antigen IFB))
Clinical Specificity
99.1 % ( (Antigen COVID-19); )
Type of antigen
Nucleoprotein
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