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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 COVIDENT COVID-19

Manufactured by Pierenkemper GmbH, Germany - https://covident.health/ 

Device identification number
2672
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
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), B.1.1.529 (Omicron), 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
Test is listed by the German Federal Institute for Drugs and Medical Devices as the SARS-CoV-2 Antigen (List of antigen rapid tests for professional use (§1 sentence 1 TestV, reimbursement) according to Test Law Regulation.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
425 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.78 % (test has total sensitivity (PPA) of 99.22% with 4 different specimens)
Fn
0.11 % (test has total specificity (NPA) of 99.89% with 4 different specimens)
Precision
Evaluated
Accuracy
99.41 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.27 %
Clinical Specificity
100 %
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