COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

5805

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Lab-based

Physical Support

Cartridge

Target type

Nucleic acid

Targets

envelope protein/gene, nucleocapsid protein/gene, Other (RdRP: RNA dependent RNA polymerase gene)

Specimen

Anterior nasal swab, Mid-turbinates swab, Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Herpes Simplex (HSV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B Victoria, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (SARS-coronavirus, Urbani; Neisseria mucosa; Propionibacterium anes; Pseudomonas aeruginosa; diverse Stephylococcus spp.; Influenza C; Pneumocystis jivecii; Lactobacillus reuterii; Neusseria meninitides; Echovirus; ), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus

Pathogens detected

SARS-CoV-2

Lineages detected

A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-12-22 08:49:46 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

Yes

Self Test

No

Reader Required

N.A.

Subcategory

N.A.

Method

RT-PCR

Measurement

Qualitative

Subclass

Multiple

Detection Principle

Other (Molecular probes)

Analytical Sensitivity

100 % (Nasal specimens)

Analytical Specificity

100 % (Nasal specimens)