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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)

Manufactured by Nanjing Synthgene Medical Technology Co., Ltd., China - http://www.syngenemed.com/ 

Device identification number
2164
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Card, Cassette, Lateral flow, Strip
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1 A.23.1 AT.1 AT.1 B.1.1.7 (Alpha), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.351 (Beta), B.1.427 (Epsilon), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.525 (Eta), B.1.526 (Iota), B.1.526 (Iota), B.1.616 B.1.616 B.1.617.1 (Kappa), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.2 (Delta), B.1.617.3 B.1.617.3 B.1.621 (Mu), B.1.621 (Mu), C.36 C.36 C.37 (Lambda), C.37 (Lambda), P.1 (Gamma), P.1 (Gamma), P.2 (Zeta), P.2 (Zeta), P.3 (Theta), P.3 (Theta), B.1.526.1 B.1.526.2 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The product is used for the qualitative detection of SARS-COV-2 infection. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. The test can be performed at the patient’s medical facility (POC – point of care-conditions). The negative result cannot rule out novel coronavirus infection, and it can not be used alone as a basis for treatment and disease management decisions.The positive result of the antigen test can be used for early triage and rapid management of suspected infected people, but the positive result only indicates the presence of the novel coronavirus N-Protein (Nucleocapsid) in the sample, and cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by the novel coronavirus. It should be combined with nucleic acid testing, imaging and other diagnostic information, medical history, and contact history to determine the status of infection. Coronavirus belongs to the order Nidoviridae, and the coronavirus family is divided into three genera of α ,β, and γ. α and β are only pathogenic to mammals, and γ mainly causes bird infections. COV is mainly transmitted through direct contact with secretions or through aerosols and droplets. There is also evidence that it can be transmitted through fecal or oral routes.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
100 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.67 %
Fn
0.5 %
Precision
Evaluated
Accuracy
99.45 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.33 %
Clinical Specificity
99.5 %
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