COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2198

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Manual

Physical Support

Card, Cassette, Dipstick, Lateral flow, Strip

Target

IgG

Specimen

Plasma, Serum, Venous whole blood, Whole blood

Pathogens detected

SARS-CoV

Lineages detected

A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.3 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),

Commercial Status

Commercialised

Last Update

2021-06-09 11:07:54 CET

Comments

This product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody IgG in human serum, plasma, whole blood and/or fingertip blood. This product uses capture method for detection. The gold label pad is marked with S-RBD protein, and the detection line is coated with mouse-anti-human IgG. When the sample contains neutralizing antibody IgG, it will bind to the S-RBD protein, then the complex will be captured by pre-coated mouse anti-human IgG and the T line will show color. When the sample does not contain neutralizing antibodies IgG, the T line will not show color. The quality control line is coated with goat anti-mouse polyclonal antibody. The C line will show color regardless of whether the sample contains neutralizing antibody IgG.

Assay Type

Immuno-Antibody

Reader Required

No

Subcategory

Sample collection device

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Capture

Detection Principle

Colloidal gold

LOD

100 AU

Calibration

Evaluated

Crossreactivity

Evaluated

Fp

4.2 %

Fn

7.8 %

Precision

Evaluated

Accuracy

94 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

92.2 %

Clinical Specificity

95.7 %

Type of antigen

Other