COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

4056

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Near POC / POC

Physical Support

Other (RT-LAMP amplification device including single-use cartridge)

Target type

DNA, Nucleic acid, RNA

Targets

ORF1ab polyprotein/gene, spike protein/gene

Specimen

Anterior nasal swab

Cross-reactivity (pathogens tested)

Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (Human mastadenovirus A-G, Human parainfluenza virus (Human respirovirus 1,3, Human orthorubulavirus 2,4), Enterovirus (including Rhinovirus), Legionella pneumophila, Streptococcus pneumoniae, Streptococcus pyogenes, Pneumocystis jirovecii,Candida albicans), Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV, SARS-CoV-2

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

2022-10-06 08:47:17 CET

Assay Type

Nucleic acid-Other

Rapid Diagnostic

Yes

Self Test

No

Reader Required

No

Subcategory

N.A.

Method

LAMP

Measurement

Qualitative

Time

45 minutes

Subclass

N.A.

Detection Principle

Other (Nucleic amplification)

Clinical Sensitivity

96.1 %

Clinical Specificity

100 %