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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Panbio Covid-19 Ag Rapid Test

Manufactured by Abbott Rapid Diagnostics, Germany - https://www.globalpointofcare.abbott/en/index.html 

Device identification number
1232
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1 AT.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.616 B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.526.1 B.1.526.2 B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-05-04 11:48:24 CET
Comments
Available for Professional use (Nasal and Nasopharyngeal) and Self-Test (Nasal)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 AU
Precision
Evaluated
Accuracy
100 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99 %
Type of antigen
Other

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