COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1919

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Cassette

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Pathogens detected

Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Enterovirus/Coxsackievirus B4, Influenza A H7N9, Legionella pnuemophila, Streptococcus pneumoniae, Streptococcus pyogenes (group A), Staphylococcus aureus, Staphylococcus epidermidis, Candida albicans), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus, SARS-CoV

Type of Antigen (in case of Antigen-based)

Nucleocapsid protein

Lineages detected

B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)

Commercial Status

Commercialised

Last Update

2022-10-31 09:12:45 CET

Comments

COVID-19 Ag Test is the chromatographic assay used for qualitative detection of the COVID-19 antigen in human nasopharyngeal swab / oropharyngeal swab / nasal swab specimen. This test kit uses COVID-19 monoclonal antibody and goat anti-mouse IgG polyclonal antibodies that are respectively immobilized on a nitrocellulose membrane. It uses colloidal gold to label sufficient COVID-19 monoclonal antibody, using nano-colloidal gold technology and applying highly specific antibody-antigen reaction and immunochromatographic analysis technology principle. When testing, the COVID-19 antigen in the sample combined with the colloidal gold-labeled COVID-19 monoclonal antibody to form a complex, which was then combined with the COVID-19 monoclonal antibody coated in the T line during chromatography, at this time there is one red line in the T area .When the samples do not contain COVID-19 antigen, colloidal gold-labeled COVID-19 monoclonal antibody cannot combined with COVID-19 monoclonal antibody in the T line region, so there is no red colored line in the T area. Regardless of the presence of COVID-19 antigen in the sample, a red line will form in the quality control area (C). The red line appears in the quality control area (C) serves as 1.verification that sufficient volume is added. 2.That proper flow is obtained 3. And as a control for the reagents.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Validity test kit

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Membrane-based

Detection Principle

Colloidal gold

LOD

22.5 TCID50/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

%

False negatives

18 %

Precision

Evaluated

Accuracy

91.09 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

82 %

Clinical Specificity

100 %

Type of antigen

Nucleoprotein