COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2365

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Near POC / POC

Physical Support

Strip

Target type

Antigen

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, 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, Rhinovirus A, Rhinovirus B

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The LoD of this kit is 491TCID50/mL.

Assay Type

Immuno-Antigen

Reader Required

Yes

Subcategory

Extraction kit

Method

Immunochromatography

Measurement

Qualitative

Time

15 minutes

Subclass

Sandwich, Double

Detection Principle

Colloidal gold

LOD

491 AU

Calibration

Not evaluated

Analysis of cross reactivity

Evaluated

False positives

4 AU

False negatives

0 %

Precision

Evaluated

Accuracy

98 %

Reproducibility

Evaluated

Robustness

Not evaluated

Clinical Sensitivity

96 % ((Antigen))

Clinical Specificity

100 % ((Antigen))

Type of antigen

Nucleoprotein