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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 Antigen Rapid Test Kit (Fluorescence Immunochromatography)

Manufactured by ADS Biotec Inc., United States - www.adsbiotec.com 

Device identification number
2448
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Serum
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Varicella Zoster Virus (VZV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://4ffkhs61xjo3g7q3l6b7s61t.wpengine.netdna-cdn.com/wp-content/uploads/YIG-AR-0010-SARS-CoV-2-Antigen-Rapid-Test-CE-IVD-declaration.pdf Note: additional materials required that are not supplied include UV flashlight with a wavelength of 365 nm, vortex mixer and timer. LOD; Serum - 3.5 pg/mL Swabs - 7.0 pg/mL
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Fluorescence
LOD
7 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 % ( (serum) )
False positives
0.4 % ( (swab))
False negatives
4 % ( (serum) )
False negatives
3 % ( (swab))
Precision
Evaluated
Accuracy
97.72 % ((95.54%-99.23%).)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.04 % ((serum))
Clinical Sensitivity
97.12 % ( antigen (swab); )
Clinical Specificity
98.9 % ((serum))
Clinical Specificity
99.6 % ( antigen (swab) )
Type of antigen
Nucleoprotein

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