COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3031

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Physical Support

Strip

Target type

Nucleic acid

Specimen

Nasopharyngeal swab

Cross-reactivity (pathogens tested)

Adenovirus, Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV

Pathogens detected

SARS-CoV

Information on antigen epitope targeted by the antibodies used in the design of the device

N gene, RdRP Gene, E gene

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The STAT-NAT® SARS-CoV-2 kit is a lyophilized Real-Time RT-PCR multiplex assay based on nucleic acid amplification for the qualitative detection of RNA from the SARS-CoV-2, in human nasopharyngeal swab specimens. This assay is an aid in the diagnosis of SARS-CoV-2 infection. Extraction Kit: STAT-NAT® Total DNA/RNA extraction kit (REF. 1N1000) or Diagnostics STAT-NAT® Pathomag extraction kit (REF.1N1001). Real-Time PCR Thermal Cycler SENTiNAT® MICRO, Bio-Rad CFX96TM DX and Applied Biosystem ABI QuantStudioTM 5 Dx.

Assay Type

Nucleic acid-PCR

Self Test

No

Subcategory

Other ()

Method

RT-PCR

Measurement

Qualitative

LOD

5 cpr

Positive control

Already included in the kit

Throughput

Single tube