COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2092

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Fully automated (robot), Manual

Target type

Nucleic acid

Specimen

Nasopharyngeal swab, Oropharyngeal swab

Cross-reactivity (pathogens tested)

Influenza A, Influenza A H1N1, Influenza B, Influenza B Yamagata

Lineages detected

A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (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

Kit for identification of the respiratory viruses severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Influenza A and Influenza B by one-step Real-Time RT PCR; Specimens: Nasopharyngeal swab Oropharyngeal swabs; Target: RdRp and N genes for SARS-CoV-2; M gene for Influenza A and B and endogenous Internal Control; No cross-reactivity confirmed with other respiratory pathogens including SARS, MERS and SARS-related viruses; Diagnostic specificity SARS-CoV-2 99.6% Influenza A virus 100% Influenza B virus 100% Diagnostic sensitivity SARS-CoV-2 99% Influenza A virus 98.6% Influenza B virus 100% Accuracy SARS-CoV-2 99.5% Influenza A virus 99.5% Influenza B virus 100%

Assay Type

Nucleic acid-PCR

Method

RT-PCR

Time

100 minutes

LOD

7.71 cpr (SARS-CoV-2 7.71 cpr Influenza A 7.87 cpr Influenza B 4.35 cpr)

Positive control

Positive control ABFlu-CoV2 (DNA containing part of the Influenza A, Influenza B and SARS-CoV-2 geno

Accuracy

99.5 %

Clinical Sensitivity

99 %

Clinical Specificity

99.6 %