COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2876

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Cassette

Target type

Antigen

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

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, Coronaviruses (HCoV), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, 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, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

N1b nucleoprotein is the analyte. This is most commonly fatal as this protein binds that RNA. The buffer does not contain Triton X-100

Assay Type

Immuno-Antigen

Reader Required

No

Method

Immunochromatography

Measurement

Quantitative

Time

15 minutes

Subclass

Sandwich, Double

LOD

29 ct (using RT-PCR)

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

None known

False negatives

This makes no sense. The false negative rate is dependent on the incidence

Precision

Evaluated

Accuracy

98.2 % (Antigen)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98 % (Antigen)

Clinical Specificity

98.3 % (Antigen)

Type of antigen

N1b nucleoprotein