COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2322

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based, Manual, Semi-automated

Physical Support

Microtiter plate

Specimen

Nasal swab, Nasopharyngeal swab, Oropharyngeal swab

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), Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A, Influenza B, MERS-CoV, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV

Lineages detected

B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

The GSD NovaType II SARS-CoV-2 is a real-time reverse transcription PCR (RT-PCR) assay designed for the simultaneous qualitative detection of the SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) mutations K417N, E484K and N501Y within the spike (S) gene and discrimination of these mutations from the wildtype sequence. Detection of these mutations is intended to aid in the identification of SARS-CoV-2 variants of concern (VOC). Sample material should be genomic RNA extracted from human upper respiratory (nasal wash/smear, nasopharyngeal wash/smear, oropharyngeal swab) specimen types that have previously tested positive for SARS-CoV-2 RNA by diagnostic RT-PCR methods e.g. GSD NovaPrime® SARS-CoV-2 (COVID-19). The GSD NovaType II SARS-CoV-2 is not intended as stand-alone test for diagnosis of SARS-CoV-2 infection and should only be used in conjunction with a SARS-CoV-2 screening RT-PCR assay.

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

60 minutes

LOD

K417N: 40.08cpr; E484K: 13.44 cpr; N501: 10.08 cpr; N501Y: 13.44 cpr

Positive control

Yes, will be provided within the kit.