COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2460

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Lab-based

Target type

Nucleic acid

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Sputum

Cross-reactivity (pathogens tested)

SARS-CoV

Lineages detected

A.23.1, AT.1, 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

Multiplex Real-Time RT-PCR kit for the specific detection of SARS-CoV-2 in human samples by simultaneous retrotranscription and amplification of specific target region of Sars-CoV-2 genome (RdRp gene and N gene). In the same reaction tube an endogenous human gene is used as extraction/amplification reaction control (Internal Control).

Assay Type

Unknown

Method

RT-PCR

Measurement

Semiquantitative

Time

75 minutes

LOD

750 copies/ml

Analytical Sensitivity

100 %

Analytical Specificity

100 %

Clinical Sensitivity

100 %

Clinical Specificity

100 %