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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Reszon COVID-19 Rapid Antigen Test (Nasal Swab)

Manufactured by Reszon Diagnostics International Sdn. Bhd., Malaysia - https://reszonics.com/ 

Device identification number
2938
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Reszon COVID-19 Rapid Antigen Test (Nasal Swab) is an immunochromatographic assay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human anterior nasal swab specimen. It is intended to be used for the detection of SARS-CoV-2 virus infection. The results obtained should not be the sole determinant for clinical decision. The Reszon COVID-19 Rapid Antigen Test (Nasal Swab) is intended for use by clinical laboratories or healthcare workers for point-of-care testing and home self-testing.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
150 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % 0 out of 140 negative samples
Fn
2.8 % (3 out of 107 positive samples)
Precision
Evaluated
Accuracy
98.8 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.27 % (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