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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 (Colloidal Gold Method)

Manufactured by Neo-nostics (Suzhou) Bioengineering Co., Ltd., China

Device identification number
2608
CE Marking
Yes
HSC common list (RAT)
Yes
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
This reagent is used for in vitro qualitative test of COVID 19 antigen N protein in human nasal samples. Synthetic spinous protein and genetic variants of UK cannot be detected. It is only used as a supplementary test indicator for suspected cases with negative result of COVID 19 test or combined with the 2019-nCov IgG / IgM antibody test kit for the auxiliary diagnosis of suspected cases. It cannot be used as a basis for confirmation or diagnosis of pneumonia caused by COVID 19 infection. A positive test result needs further confirmation, and a negative test result cannot exclude the possibility of infection. The test kit is recommended to be used by individuals above 18 years old. For the individuals under the age of 18 years old or older than 65 years old, the test should be done under the supervision or assistance of another adult. The 2019 novel coronavirus is also known as COVID 19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the COVID 19 are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0.1 ng/mL
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.8 % ((1/123))
Fn
4.1 % ((5/123))
Precision
Evaluated
Accuracy
97.56 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.93 %
Clinical Specificity
99.19 %
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