COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2091

CE Marking

✓Yes

HSC common list

×No

HSC mutual recognition

×No

Format

Automated, Manual, Semi-automated

Target

Nucleic acid

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Pathogens detected

Coronaviruses (HCoV), MERS-CoV, SARS-CoV

Lineages detected

A.23.1 (United Kingdom), AT.1 (Russia), B.1.1.7 (United Kingdom), B.1.351 (South Africa), B.1.427 (USA), B.1.429 (USA), B.1.525 (Nigeria), B.1.526 (USA), B.1.526.1 (USA), B.1.526.2 (USA), B.1.616 (France), B.1.617.1 (India), B.1.617.2 (India), B.1.617.2 (India), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil), P.3 (The Philippines),

Commercial Status

Commercialised

Last Update

2021-05-27 01:35:19 CET

Comments

Kit for detection of RdRp and S genes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab Oropharyngeal swabs; Target: S, RdRP genes and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses; Diagnostic specificity = 100% Diagnostic sensitivity = 100% Accuracy = 100%

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

100 minutes

LOD

3.57 cpr

Positive control

Positive control SARS-CoV-2 (DNA containing part of the SARS-CoV-2 genome and RNaseP gene)

Clinical Sensitivity

98.1 %

Clinical Specificity

100 %

Type of antigen

S, RdRP genes