COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2189

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Card, Cassette, Dipstick, Lateral flow, Strip

Target type

Antibody

Specimen

Plasma, Serum, Venous whole blood, Whole blood

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

This product is used for in vitro qualitative detection of novel coronavirus(COVID-19)(Sars-CoV-2) neutralizing antibody in human serum, plasma, whole blood and/or fingertip blood. This product uses double antigen sandwich method for detection. The gold label pad is marked with S-RBD-mFc C-terminal, and the detection line is coated with S-RBD-mFc N-terminal. When the sample contains neutralizing antibody, it will bind to S-RBD-mFc C-terminal, then the complex will be captured by pre-coated S-RBD-mFc N-terminal and the T line will show color. When the sample does not contain neutralizing antibodies, 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.

Assay Type

Immuno-Antibody

Subcategory

Sample collection device

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Neutralization Antibody (NAb)

Detection Principle

Colloidal gold

LOD

20 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

3 %

False negatives

7 %

Precision

Evaluated

Accuracy

95 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

93 %

Clinical Specificity

97 %

Type of antigen

Other