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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 Sealing Tube Test Strip (Colloidal Gold)

Manufactured by Amazing Biotech (Shanghai) Co. Ltd., China

Device identification number
2075
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Strip
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Rhinovirus
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
It is an in vitro lateral flow immunochromatographic assay for qualita-tive detection of nucleocapsid protein of SARS-CoV-2 virus in human nasopharyngeal, nasal secretion specimens directly collected from individuals suspected of COVID-19 within the first seven days after the onset of symptoms. It’s a quick and easy-to-use test in the diag-nosis of SARS-CoV-2 infection to humans. The results should not be used as the sole basis for diagnosis. The innovative design of test strip packed in a sealing tube can minimize potential biological risks of pathogen contamination to users and the environment. The test is for professional use only and can be used by medical profes-sionals, laboratory personnel or individuals trained for point-of-care test.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
312 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3.382 % ( (Nasal Swab))
False negatives
0.713 % ( (Nasal Swab))
Precision
Evaluated
Accuracy
98.407 % ( (Antigen) (Nasal Swab))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.618 % ( (Antigen) (Nasal Swab))
Clinical Specificity
99.287 % ((Antigen) (Nasal Swab))
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