S2 Covid-19 Rapid Antigen Test Kit
Manufactured by Sensing Self Pte. Ltd., Singapore - www.sensingself.me
Device identification number
2039
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The S2 Covid-19 Rapid Antigen Test Kit LOD value is 1.25 X 103 TCID50/mL.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
1250 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (450 samples are proven negative of 450 negative specimens)
False negatives
2.87 % ((6 samples are proven negative of 209 positive specimens))
Precision
Evaluated
Accuracy
99.09 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.13 %
Clinical Specificity
99.99 %
Type of antigen
Nucleoprotein
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