COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2818

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Latex

Target type

Antigen

Specimen

Nasal swab

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The product is intended for the qualitative detection of nucleocapsid protein antigen from SARS- CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms.Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection.COVID-19 is an acute respiratory infectious disease that is highly susceptible to human infection.Currently, the patients infected by the novel coronavirus are the main source of infection,asymptomatic infected people can also bean infectious source.Based on the current epidemiological investigation, the incubation period for COVID-19 ranges from 1 to 14 days,with most cases ranging from 3 to 7days,the main manifestations include fever,fatigue,and dry cough.Nasal congestion,runny nose,sore throat,myalgia, and diarrhea are

Assay Type

Immuno-Antigen

Rapid Diagnostic

Yes

Reader Required

No

Method

Immunoassay

Measurement

Quantitative

Time

15 minutes

Detection Principle

Colorimetry

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

1 AU

False negatives

2 AU

Precision

Evaluated

Accuracy

95 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

96 %

Clinical Specificity

99.9 %

Type of antigen

Spike protein