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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ScheBo SARS CoV-2 Quick ANTIGEN (Colloidal Gold Method)

Manufactured by ScheBo Biotech, Germany - www.schebo.com 

Device identification number
2763
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, Varicella Zoster Virus (VZV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ScheBo SARS-CoV-2 Quick Antigen (Colloidal Gold Method)
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
200 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.51 % (1/196)
False negatives
3.87 % (5/129)
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.12 %
Clinical Specificity
99.49 %
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