COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1931

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette

Target type

Antigen

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The product is based on the principle of sandwich and colloidal gold immunochromatography, the nitrocellulose membrane Test Zone is pre-coated with mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody, the Control Zone is pre-coated with goat anti-mouse polyclonal antibody, the gold conjugation pad is pre-coated with colloidal gold labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody. When testing positive samples, Influenza A/B/COVID-19 Antigen the sample will be combined with colloidal gold (Au) labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody and form into immune complexes (Au-mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody-[ Influenza A/B/COVID-19- (Antigen)]), the complexes will move forward inside the nitrocellulose membrane by chromatography effect. When reaching Test Zone, the complexes will be combined with mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody, and form into “(Au-mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody-[COVID-19- (Antigen)])-[ mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody]”, thus agglutination color appears; The residual colloidal gold labeled mouse anti-Influenza A/B/Corona Virus (COVID-19) monoclonal antibody will be combined with goat anti-mouse polyclonal antibody at the Control Zone, and produce color under agglutination. When testing negative samples, there’s no Influenza A/B/COVID-19 Antigen in the samples, no immune complexes will be formed and color only appears in the Control line.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Subcategory

Other ()

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

Detection Principle

Colloidal gold

LOD

5.25 AU

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

1 % (COVID-19)

False positives

1.5 % (FluB)

False positives

2 % (FluA)

False negatives

4 % (COVID-19)

False negatives

8 % (FluB)

False negatives

6 % (FluA)

Precision

Evaluated

Accuracy

97.5 % (FluA)

Accuracy

95.3 % (FluB)

Accuracy

98.4 % (COVID-19)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

94 % (FluA)

Clinical Sensitivity

92.1 % (FluB)

Clinical Sensitivity

96 (COVID-19)

Clinical Specificity

98 % (FluA)

Clinical Specificity

98.5 % (FluB)

Clinical Specificity

99 (COVID-19)

Type of antigen

Other