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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LIAISON® SARS-CoV-2 Ag

Manufactured by DiaSorin S.p.A, Italy - www.diasorin.com/ 

Device identification number
1960
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Lab-based
Physical Support
Card
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-06-08 10:41:09 CET
Comments
The method for quantitative determination of SARS-CoV-2 Ag in specimens collected and processed through the indicated pre-analytical procedure, is a direct two-step sandwich chemiluminescence immunoassay (CLIA). Specific rabbit polyclonal antibodies to nucleocapsid antigen are used for coating magnetic particles (solid phase) and linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, SARS-CoV-2 viral antigen present in calibrators, samples or controls binds to the conjugate. During the second incubation, the solid phase reacts with the SARS-CoV-2 viral antigen already bound to the conjugate. After the second incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added, and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier in relative light units (RLU) and is directly proportional to the SARS-CoV-2 viral antigen concentration present in calibrators, samples, or controls.
Assay Type
Immuno-Antigen
Rapid Diagnostic
No
Reader Required
Yes
Method
CLIA
Measurement
Quantitative
Time
42 minutes
Subclass
Sandwich
Detection Principle
Chemiluminescence
LOD
22 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99 %
Clinical Specificity
98 %
Type of antigen
nucleocapside protein
Notes
LIAISON® SARS-CoV-2 Ag (311490)

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