Device identification number

665

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette, Strip

Target type

Antibody, IgG, IgM

Targets

nucleocapsid protein

Specimen

Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

SARS-CoV

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This assay is based on a colloidal gold method for the rapid, qualitative determination of Anti-SARS-CoV-2 (IgG/IgM antibodies of Severe Acute Respiratory Syndrome Coronavirus 2) in human serum, plasma or whole blood. IgM Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 85.43% (346/405), (95%CI: 81.7% - 88.5%), IgM Negative Percent Agreement was 99.68% (311/312), (95%CI: 98.2% - 99.9%). IgG Positive Percent Agreement of Anti-SARS-CoV-2 Rapid Test was 86.17% (349/405), (95%CI: 82.5% - 89.2%), IgG Negative Percent Agreement was 99.36% (310/312), (95%CI: 97.7% - 99.8%).

Assay Type

Immuno-Antibody

Rapid Diagnostic

Yes

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Capture

Detection Principle

Colloidal gold

Analysis of cross reactivity

Evaluated

Precision

Evaluated

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

88.15 % ( (357/405) (95%CI: 84.6%-90.9%))

Clinical Specificity

99.04 % ( (309/312), (95%CI: 97.2%-99.7%))

Type of antigen

SARS-CoV-2 nucleocapsid