COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

1995

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Cassette

Target type

Antigen

Specimen

Anterior nasal swab, Nasopharyngeal swab, Saliva

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

[Reagents and Materials Provided] COVID-19 Antigen Rapid Test (20 each) Foil pouched test device containing one test strip which is encased in plastic device cassette and one piece of desiccants. Extraction Buffer Vial (20 each) The extraction buffer vial contains 300μl extraction buffer solution. Collection Swab (20 each) Swabs for nasopharyngeal specimen collection (model CAR1) or swabs for anterior nares specimen collection (model CAR2). Collection Vial (20 each) Vial for the mix of swab specimen and extraction buffer. Preparation Plate (1 each) A 20-holes preparation plate, for fixing the collection vial. Package Insert (1 each) Instructions for use.

Assay Type

Immuno-Antigen

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

LOD

22.5 AU

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

2.17 % ((2/92))

False negatives

0 % (0/78)

Precision

Evaluated

Accuracy

98.8 %

Reproducibility

Evaluated

Robustness

Not evaluated

Clinical Sensitivity

97.5 %

Clinical Specificity

100 %

Type of antigen

Nucleoprotein