COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2176

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Manual

Target type

Nucleic acid

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Saliva

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

B.1.1.7 (Alpha),

Commercial Status

Commercialised

Last Update

2022-08-24 09:08:01 CET

Comments

The coviNplex™ assay is a molecular in vitro diagnostic test that aids in the detection and diagnosis of 2019-nCoV, being based on widely used nucleic acid amplification technology. The kit contains oligonucleotide primers and dual-labeled hydrolysis probes (TaqMan®) used in RT-PCR for qualitative detection of 2019-nCoV RNA in upper respiratory and saliva specimens. Oligonucleotide primers and probes for specific detection of SARS-CoV-2 are designed to target the nucleocapsid gene (N) of the SARS-CoV-2 genome. The kit includes primers/probes for amplifiy 2 gene of SARS-CoV-2. An endogenous internal control is also included for the human RNase P gene to confirm RNA integrity and absence of PCR inhibitors.

Assay Type

Nucleic acid-PCR

Method

RT-PCR

LOD

6 cpr

Clinical Sensitivity

100 %

Clinical Specificity

100 %