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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

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

Device identification number
2576
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Reszon COVID 19 Rapid Antigen Test is an immunochromatographic assay designed for the qualitative detection of specific SARS-CoV-2 antigen in human nasopharyngeal swab specimen .The results obtained should not be the sole determinant for clinical decision.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
150 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % 0 out of 110 negative samples
Fn
8.8 % (11 out of 125 positive samples)
Precision
Evaluated
Accuracy
95.09 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.2 % ( (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