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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 (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
IgG
Targets
spike protein,
Specimen
Plasma, Serum, Whole blood
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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 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