Redtest Professional Sars-CoV-2 Antigen Rapid Test (Covid-19 Ag)
Manufactured by Sigmed Sp. z o.o., Poland - https://redtest.eu
Device identification number
2256
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cartridge, Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Influenza A, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), SARS-CoV, Varicella Zoster Virus (VZV)
Pathogens detected
SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), 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.1.526.1, B.1.526.2, 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)
Commercial Status
Commercialised
Last Update
2022-11-14 09:05:17 CET
Comments
BfArM Listed, PEI evaluated
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
500 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
The relative Sensitivity and Specificity have been compared with the Gold Standard PCR Test
False negatives
The relative Sensitivity and Specificity have been compared with the Gold Standard PCR Test
Precision
Evaluated
Accuracy
97.98 % (Oropharyngeal swab)
Accuracy
96.67 % (Nasal swab)
Accuracy
99.37 % (Nasopharyngeal swab)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.29 % (Nasopharyngeal swab)
Clinical Sensitivity
94.66 % (Oropharyngeal swab)
Clinical Sensitivity
93.64 % (Nasal swab)
Clinical Specificity
100 % (Nasopharyngeal swab)
Clinical Specificity
100 % (Oropharyngeal swab)
Clinical Specificity
100 % (Nasal swab)
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