COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

3030

CE Marking

✓Yes

HSC common list (RAT)

×No

Target type

Nucleic acid

Targets

envelope protein/gene, nucleocapsid protein/gene, ORF1ab polyprotein/gene

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata

Pathogens detected

Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata

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

FDA preEUA

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

35 minutes

LOD

200 cpm

Throughput

Higher than 96 samples per run

Notes

1-step viral RNA sample processing for direct RT-PCR analysis