COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2070

CE Marking

×No

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Specimen

Anterior nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B

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 Reagnz uses a double antibody sandwich to legally detect the antigen of the novel coronavirus (SARS-CoV-2) in nasal (NS) swab samples. During the detection, the gold-labeled anti-SARS-CoV-2 monoclonal antibody in the labeling pad binds to the SARS-CoV-2 antigen in the sample and the chromatography forwards. It is precoated by the anti-SARS-CoV-2 monoclonal antibody which ultimately creates a red color reaction line in the T-zone. If the sample does not contain any SARS-CoV-2 antigen, a red reaction line always forms in the quality control area (C).

Assay Type

Immuno-Antigen

Reader Required

No

Subcategory

Other ()

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

LOD

400 AU

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

2 AU

False negatives

15 AU

Precision

Evaluated

Accuracy

98 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

97 %

Clinical Specificity

99 %

Type of antigen

Nucleoprotein