COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2869

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual, Near POC / POC

Physical Support

Latex

Target type

Antigen

Targets

spike protein

Specimen

Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.529 (Omicron), 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 saliva from individuals suspected of COVID-19 by their healthcare provider or personage 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 found in a few cases.

Assay Type

Immuno-Antigen

Self Test

Yes

Reader Required

No

Subcategory

Validity test kit

Method

Immunoassay

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich

Detection Principle

Colorimetry

LOD

2.5 µg/ml

Calibration

Evaluated

Analysis of cross reactivity

Evaluated

False positives

2 AU

False negatives

0 AU

Precision

Evaluated

Accuracy

99.29 %

Reproducibility

Evaluated

Robustness

Evaluated

Clinical Sensitivity

100 %

Clinical Specificity

96.37 %

Type of antigen

Spike protein