COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1900

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based

Physical Support

Cartridge

Target type

IgG

Specimen

Plasma, Serum

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The LIAISON® SARS-CoV-2 TrimericS IgG assay uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of anti-trimeric spike protein specific IgG antibodies to SARS-CoV-2 in human serum or plasma samples. The assay is intended as an aid in the diagnosis of CoVID-19 and to support the study of the immune status of infected patients by providing an indication of the presence of neutralizing IgG antibodies against SARS-CoV-2. Results from the LIAISON® SARS-CoV-2 TrimericS IgG assay should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform about infection status. The test has to be performed on the LIAISON® XL Analyzer only. The calibrator concentrations expressed as Binding Antibody Units (BAU)/mL are referenced to the First WHO International Standard for anti-SARS-CoV-2 Immunoglobulin (20/136). Measuring range: The LIAISON® SARS-CoV-2 TrimericS IgG assay measures between 4.81 and 2080 BAU/mL. The lowest reportable value is 4.81 BAU/mL. Values below 4.81 BAU/mL should be reported as < 4.81 BAU/mL. Specimens containing high levels of anti-trimeric spike protein specific IgG antibodies to SARS-CoV-2 above the assay measuring range (> 2080 BAU/mL) may be automatically diluted using LIAISON® TrimericS IgG Diluent Accessory ([___REF___] 311512) loaded into the ancillary reagent area. The required dilution factor is 1:20. It is the responsibility of the individual laboratory to conduct studies to determine validity of dilutions other than 1:20.

Assay Type

Immuno-Antibody

Reader Required

Yes

Method

Immunoassay

Time

35 minutes

Detection Principle

Chemiluminescence

LOD

1.85 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

N.A.

False negatives

N.A.

Accuracy

99 % IgG

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.7 % IgG

Clinical Specificity

99.5 % IgG

Type of antigen

anti-trimeric spike protein specific IgG antibodies to SARS-CoV-2