COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2877

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based

Physical Support

Microplate, Strip

Target type

Nucleic acid

Targets

nucleocapsid protein/gene, ORF1b polyprotein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Coronaviruses (HCoV)

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

RevoDx SARS-CoV-2 qPCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in respiratory samples such as human oropharyngeal (OP) swab, nasopharyngeal (NP) swab or combined nasopharyngeal (NP) and oropharyngeal (OP) swab from individuals who are suspected of COVID-19 by their healthcare provider.

Assay Type

Nucleic acid-PCR

Self Test

No

Method

RT-PCR

Measurement

Qualitative

Time

47 minutes

LOD

58 copies/ml

Positive control

yes

Negative control

yes