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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AMPER COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)

Manufactured by AMPER Inc., United States - http://www.amperbio.com 

Device identification number
2936
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B Victoria, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-05 02:04:25 CET
Comments
NA
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
625 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
6 %
Precision
Evaluated
Accuracy
93.64 % ((103/110) [95% CI, 87.44% – 96.88%])
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.64 % (Antigen)
Clinical Specificity
100 %
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