COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2003

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette, Lateral flow

Target type

Antigen

Targets

nucleocapsid protein

Specimen

Deep (cough) sputum, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

SG Diagnostics COVID-19 Antigen Rapid Test Kit showed no cross-reactivity with the following potentially cross-reactive common organisms - Human coronavirus (229E, HKU1, OC43 and NL63), Middle East respiratory syndrome (MERS) coronavirus, Adenovirus, Enterovirus, Influenza A (H1N1 and H3N2) and B viruses, Avian influenza virus, Parainfluenza type 1-4, Measles virus, Human metapneumovirus, Mumps virus, Rhinovirus, Epstein-Barr virus, Respiratory syncytial virus, Staphylococcus aureus, Streptococcus pneumoniae, Staphylococcus epidermidis, Mycobacterium tuberculosis, Legionella pneumophila, Haemophilus influenza, Streptococcus pyogenes, Chlamydia pneumoniae, Mycoplasma pneumoniae, Candida albicans, organisms that make up normal respiratory flora, and organism(s) that causes parapertussis and pneumocystis.

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunochromatography

Measurement

Qualitative

Time

10 minutes

Subclass

Membrane-based

Detection Principle

Colloidal gold

LOD

75 AU

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

Precision

Evaluated

Accuracy

98.99 %

Reproducibility

Evaluated

Robustness

Not evaluated

Clinical Sensitivity

97.57 %

Clinical Specificity

99.29 %

Type of antigen

Nucleoprotein