COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3121

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Manual, Semi-automated

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1ab polyprotein/gene, spike protein/gene

Specimen

Nasopharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

Adenovirus, 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), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, 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), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV, Varicella Zoster Virus (VZV)

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

2022-08-24 09:08:01 CET

Comments

Kit for detection of RdRp, N and S genes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab; Target: N, S, RdRP genes and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses;

Assay Type

Nucleic acid-PCR

Subcategory

Other ()

Method

RT-PCR

Measurement

Qualitative

Time

70 minutes

Subclass

JRC-S

LOD

4.1 cpr

Positive control

Positive control SARS-CoV-2 (DNA containing part of the SARS-CoV-2 genome and RNaseP gene)

Clinical Sensitivity

99 %

Clinical Specificity

100 %

Throughput

96 samples per run