(SARS-CoV-2) Antigen Rapid Test COVIDENT COVID-19
Manufactured by Pierenkemper GmbH, Germany - https://covident.health/
Device identification number
2197
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual, Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Throat secretion, Throat swab
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, SARS-CoV
Lineages detected
A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),
Commercial Status
Commercialised
Last Update
2021-06-09 11:03:18 CET
Comments
Test is already 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) and has also special approval by the German Federal Institute for Drugs and Medical Devices as the antigen Test for Self-Testing.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
150 AU
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
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