COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2074

CE Marking

✓Yes

HSC common list (RAT)

✓Yes

Format

Near POC / POC

Physical Support

Card

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva

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, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, 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, SARS-CoV

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), 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

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.1.617.1(Kappa); B.1.617.2 (Delta); B.1.617.3;B.1.621 (Mu); C.36;P.1(Gamma); P.2(Zeta); P.3 (Theta); C.37 (Lambda); B.1.616; B.1.1.529 (Omicron); B.1.526.1; B.1.526.2;

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

Other ()

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

LOD

40 TCID50/ml (40-100TICD 50/ml)

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

1.49 %

False negatives

0.09 %

Precision

Evaluated

Accuracy

99.54 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.51 %

Clinical Specificity

99.91 %

Type of antigen

Nucleocapsid protein