PixoTest® POCT COVID-19 Antigen Test
Manufactured by iXensor, Taiwan ROC - https://www.ixensor.com
Device identification number
2217
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
PixoTest POCT Antigen Testing solution is an analyzer based rapid antigen test designed for point-of-care. It provides an end-to-end fully digitalized solution from rapid antigen test, timely result with digital pass issuing and access control by cross-validating test results on the cloud through a suite of digital tools including PixoHealth Pass App, PixoHealth Pass Admin App and Web portal for enterprises to prevent potential outbreaks.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
125 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
97 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95 % ( (Antigen))
Clinical Specificity
98 % ( (Antigen) Taipei)
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