COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2496

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC, Semi-automated

Physical Support

Cassette, Lateral flow

Target type

Antibody, IgG

Specimen

Peripheral blood, Plasma, Serum, Whole blood

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.616, B.1.617.1 (Kappa), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

COVID-19 neutralizing antibody Test is a chromatographic immunoassay for the detection of neutralizing antibodies to COVID-19 in human whole blood, serum and plasma. The test device contains: 1) Colloidal gold-labeled recombinant SARS-CoV-2 RBD antigen; 2) Detection line (T line) immobilized with SARS-CoV-2 RBD antigen for detecting COVID-19 neutralizing antibody and Control line(C line) immobilized with quality contro! antibody on nitrocellulose membrane. Ifthe sample contains COVID-19 neutralizing antibody, it will bind to antigens coated on colloidal gold, and a pink colored band will develop in the test region (T) on the membrane.If there is no COVID-19 neutralizing antibody in the sample, the pink colored band in the test region (T) will not appears and that suggests a negative result.

Assay Type

Immuno-Antibody

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Neutralization Antibody (NAb)

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

4.6 % (7 on 152)

False negatives

0 % 0 on 371

Precision

Evaluated

Accuracy

97.65 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

95.39 %

Clinical Specificity

99.9 %

Type of antigen

Other