PathFlow™ COVID-19 Rapid Antigen PRO
Manufactured by Primer Design Limited, United Kingdom - https://novacyt.com/product/pathflow-covid-19-rapid-antigen-test-pro/
Device identification number
25543
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.525 (Eta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2023-04-03 10:08:14 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Enzyme-linked
Detection Principle
Absorbance
LOD
100 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
97.6 % (Nasopharyngeal swab)
Analytical Specificity
99.7 % (Nasopharyngeal swab)
Analytical Specificity
99.9 % (Nasal swab)
Analysis of cross reactivity
Evaluated
False positives
2 AU (Nasal swab)
False negatives
8 AU (Nasal swab)
Precision
Evaluated
Accuracy
99 % (>99%)
Robustness
Evaluated
Clinical Sensitivity
93.5 % (Nasal swab)
Clinical Specificity
99.3 % (Nasal swab)
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