COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1960

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Automated, Lab-based

Physical Support

Card

Target type

Antigen

Specimen

Nasal swab, Nasopharyngeal swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 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

Analysis of cross reactivity

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)