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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Ultra COVID-19 Ag

Manufactured by SD Biosensor Healthcare Private Limited, India - www.sdbiosensor.co.in 

Device identification number
3026
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B
Pathogens detected
SARS-CoV, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-11-14 09:02:22 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Membrane-based
Detection Principle
Other (Immunochromatography assay)
LOD
6 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
5 %
False negatives
1 %
Precision
Not evaluated
Accuracy
95.6 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.47 %
Clinical Specificity
100 %
Type of antigen
Membrane 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