COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2530

CE Marking

✓Yes

HSC common list (RAT)

×No

Format

Automated, Lab-based, Manual, Semi-automated

Physical Support

Microplate

Specimen

Nasopharyngeal swab, Oropharyngeal swab, Throat swab

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

2022-12-02 09:22:17 CET

Comments

The SARS-CoV-2 RealFast™ Assay is a multiplex reverse transcription real-time PCR (RT-PCR) test for an accurate qualitative one-step detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The presence of SARS-CoV-2 specific RNA in respiratory tract specimens is associated with the Coronavirus Disease 2019 (COVID-19). The kit is intended to test patients suspected of carrying SARS- CoV-2 infection. The Assay Mix targets the N and RdRP/ORF1ab genes of SARS-CoV-2, and in addition, the human ACTB gene to simultaneously control the performance of nucleic acid extraction and RT-PCR reaction. For human in vitro diagnostic use.

Assay Type

Unknown

Reader Required

No

Subcategory

Other ()

Method

RT-PCR

Measurement

Quantitative

Time

80 minutes

LOD

10 cpr

Positive control

SARS-CoV-2 Pos. Control included

Negative control

It is advisable to run the NTC (use PCR-grade water instead of RNA) in duplicate

Analytical Sensitivity

100 %

Analytical Specificity

98.65 %