Dynamiker SARS-CoV-2 Ag Rapid Test
Manufactured by Dynamiker Biotechnology（Tianjin) Co. Ltd., China - https://en.dynamiker.com/
Device identification number
2533
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus A, Rhinovirus B, Varicella Zoster Virus (VZV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product Dynamiker SARS-CoV-2 Ag Rapid Test being listed by BfArM with AT342/21 ,and has positive results by PEI on July, 12, 2021. The version for self-test also passed the Useability study.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
160 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.9 %
False negatives
4.3 %
Precision
Evaluated
Accuracy
100 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.7 % (Antigen)
Clinical Specificity
99.1 % (Antigen)
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