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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Test Kit(Nasal/Nasopharyngeal/Oropharyngeal/Saliva)

Manufactured by Aikang Diagnostics Co. Ltd., China - http://www.aikang-medical.com 

Device identification number
3024
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
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), Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, 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), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The kit is used for in vitro qualitative detection of the novel coronavirus (COVID-19) N protein antigen in human nasopharyngeal swabs, nasal swabs, oropharyngeal swabs or saliva samples.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
100 TCID50/ml (Nasal swab)
LOD
300 TCID50/ml (Saliva swab)
LOD
300 TCID50/ml (Oropharyngeal swab)
LOD
100 TCID50/ml (Nasopharyngeal swab)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.94 % (Nasal swabs)
False positives
0.94 % (Saliva)
False positives
0.94 % (Oropharyngeal swab)
False positives
0.94 % (Nasopharyngeal swab)
False negatives
0.48 % (Nasal swab)
False negatives
0.72 % (Nasopharyngeal swab)
False negatives
0.48 % (Oropharyngeal swab)
False negatives
0.72 % (Saliva)
Precision
Evaluated
Accuracy
99.43 % (Oropharyngeal swab)
Accuracy
99.05 % (Saliva)
Accuracy
99.43 % (Nasal swab)
Accuracy
99.24 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.06 % (Nasal swab)
Clinical Sensitivity
99.06 % (Nasopharyngeal swab)
Clinical Sensitivity
99.06 % (Oropharyngeal swab)
Clinical Sensitivity
98.11 % (Saliva)
Clinical Specificity
99.52 % (Nasal swab)
Clinical Specificity
99.28 % (Nasopharyngeal swab)
Clinical Specificity
99.52 % (Oropharyngeal swab)
Clinical Specificity
99.28 % (Saliva)
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