COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2074

CE Marking

✓Yes

HSC common list

✓Yes

HSC mutual recognition

✓Yes

Format

Near POC / POC

Physical Support

Card

Target

Antigen

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

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), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, 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

Lineages detected

B.1.1.7 (United Kingdom), B.1.351 (South Africa), P.1 (Japan/Brazil),

Commercial Status

Commercialised

Last Update

2021-07-07 05:25:18 CET

Comments

The SARS-CoV-2 Antigen Rapid Test Kit is a colloidal gold enhanced double antibody sandwich immunoassay for the qualitative determination of nucleocapsid protein (N protein) from SARS-CoV-2 antigen.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

LOD

0 AU

Calibration

Evaluated

Crossreactivity

Evaluated

Fp

1.67 %

Fn

0 %

Precision

Evaluated

Accuracy

99.58 % (Antigen)

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

98.33 % (Antigen)

Clinical Specificity

100 % (Antigen)

Type of antigen

Nucleoprotein