DSI COVID-19 Ag RAPID TEST
Manufactured by Dia Sure Immunodiagnostic LLP, India - www.dsillp.com
Device identification number
3144
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The positive outcomes are to be treated as Covid positive while negative outcomes can still considered and can go for RT-PCR testing based on the clinician judgement
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0/100
False negatives
10 % (10/100)
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90 % (Antigen)
Clinical Specificity
100 % (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