ENMED SARS-CoV-2 Rapid Antigen Test Kit
Manufactured by Vitrosens Biotechnology Co. Ltd., Turkey - www.vitrosens.com
Device identification number
4083
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Throat swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, 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, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)
Pathogens detected
Other (-)
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Information on antigen epitope targeted by the antibodies used in the design of the device
Origin: The immunogen is SARS- CoV-2 nucleocapsid protein expressed by E.coli through genetic recombination Sequence: Msdngpqnqrnapritfggpsdstgsnqngersgarskqrrpqglpnntaswftaltqhgkedlkfprgqgvpintnsspddqigyyrratrrirggdgkmkdlsprwyfyylgtgpeaglpygankdgiiwvategalntpkdhigtrnpannaaivlqlpqgttlpkgfyaegsrggsqassrsssrsrnssrnstpgssrgtsparmagnggdaalalllldrlnqleskmsgkgqqqqgqtvtkksaaeaskkprqkrtatkaynvtqafgrrgpeqtqgnfgdqelirqgtdykhwpqiaqfapsasaffgmsrigmevtpsgtwltytgaiklddkdpnfkdqvillnkhidayktfpptepkkdkkkkadetqalpqrqkkqqtvtllpaadlddfskqlqqsmssadstqagggshhhhhhhhhh
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
2022-09-29 09:41:24 CET
Comments
2.Twin test of this product was evaluated and approved by Paul-Ehrlich-Institute in Germany in March 2021. 3.The LOD for this product is 50 TCID50/mL.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other (-)
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colorimetry
LOD
50 % (for SARS-CoV-2)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.95 % (5 out of 525 (Nasopharyngeal Swab))
False negatives
2.7 % (17 out of 630 (Nasopharyngeal Swab))
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.3 % (NP swab:(SARS-CoV-2))
Clinical Specificity
99.05 % (NP swab:(SARS-CoV-2))
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