COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3924

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Manual, Semi-automated

Physical Support

Microtiter plate

Target type

Nucleic acid

Targets

non-structural protein/gene NSP1, Other (ORF8)

Specimen

Nasal 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, Coronaviruses (HCoV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, 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), Rhinovirus, Rhinovirus A, SARS-CoV

Pathogens detected

Other (SARS-CoV-2 detected and no other off-panel pathogens detected)

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), Other, P.1 (Gamma), P.2 (Zeta), P.3 (Theta),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Assay Type

Nucleic acid-PCR

Rapid Diagnostic

N.A.

Self Test

N.A.

Reader Required

Yes

Subcategory

N.A.

Method

RT-PCR

Measurement

Qualitative

Time

20 minutes

Subclass

N.A.

Detection Principle

Fluorescence

LOD

23 copies/reaction

Positive control

Internal Control and Positive Extraction Control included

Negative control

Negative Extraction Control included

Clinical Sensitivity

97.7 %

Clinical Specificity

100 %

Throughput

96 samples per run