LIAISON® Quick Detect Covid Ag Assay
Manufactured by Rapid Pathogen Screening Inc., United States - www.lumosdiagnostics.com
Device identification number
2290
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
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
LIAISON® Quick Detect Covid Ag Assay is a lateral flow immunochromatographic assay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) swabs and nasopharyngeal (NP) swabs from individuals who meet COVID-19 clinical and/or epidemiological testing criteria. The test is intended for professional use only.
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Other ()
LOD
950 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
4 AU
False negatives
3 AU
Precision
Evaluated
Accuracy
96.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
97 %
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