Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AbC-19 Semi-Q Rapid Test

Manufactured by Abingdon Health Plc, United Kingdom - https://www.abingdonhealth.com/ 

Device identification number
2879
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
IgG
Targets
spike protein,
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-01-04 12:34:53 CET
Comments
The AbC-19 Semi-Q Rapid Test is a single use, in vitro immunochromatographic sandwich assay for the semi-quantitative detection of IgG antibodies against the full trimeric SARS-CoV-2 spike protein in capillary whole blood, serum and plasma (EDTA) samples.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Semiquantitative
Time
20 minutes
Subclass
Sandwich
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.44 % (2/450)
Fn
1.97 % (4/203)
Precision
Evaluated
Accuracy
99.4 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.03 % IgG
Clinical Specificity
99.56 % IgG

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