COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

25664

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Lateral flow

Target type

Antigen

Antibody type

Monoclonal

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Coxsackie virus CA16e,Coxsackie virus B5,Coxsackie virus A24,Candida albicans,Legionella pneumophila,Pneumocystis jiroveci,Streptococcus pneumoniae,Staphylococcus aureus,), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B

Pathogens detected

Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Coxsackie virus CA16e,Coxsackie virus B5,Coxsackie virus A24,Candida albicans,Legionella pneumophila,Pneumocystis jiroveci,Streptococcus pneumoniae,Staphylococcus aureus,), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B

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.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2024-12-11 11:29:50 CET

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

N.A.

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

Detection Principle

Colloidal gold

LOD

100 TCID50/ml

Calibration

Evaluated

Analytical Sensitivity

96.27 %

Analytical Specificity

99.11 %

Analysis of cross reactivity

Evaluated

False positives

0.89 %

False negatives

3.73 %

Precision

Evaluated

Accuracy

98.46 %

Robustness

Evaluated

Clinical Sensitivity

96.27 %

Clinical Specificity

99.11 %