SARS-COV-2 Ag NeoMedica (R2703Ag)
Manufactured by Neomedica d.o.o., Serbia - www.neomedica.rs
Device identification number
2234
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Deep (cough) sputum, Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The test is intended for qualitative detection of SARS-CoV-2 antigen in saliva/sputum specimens in patients in the acute (early) phase of SARS-CoV-2 infection, as well as in asymptomatic patients.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
6.31 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
There are no false positives
False negatives
There are no false negatives
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.8 %
Clinical Specificity
99 %
Type of antigen
Nucleoprotein
Notes
Ares(2021)3832559
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