SARS-Coronavirus 2 Screening, CE IVD, RT-PCR Kit

ViroGene® SARS-CoV-2 Screening RTU is a CE IVD labeled human diagnostic kit for the detection of SARS coronavirus 2, which causes the Covid-19 pandemic.

This kit is the first of two ViroGene® kits for human pathogen diagnostics to date, but it is also one of many kits for coronavirus diagnostics, that we offer. Coronaviruses are long known pathogens for respiratory diseases in poultry, cattle and pigs. We have already developed a whole range of real-time PCR kits that are highly specific and sensitive and accurately detect corona viruses and different variants. We have used this expertise to develop and validate the ViroGene® SARS-CoV-2 Screening and Confirmation Kits.

For reliable detection, the method is intentionally broadly defined to detect all SARS-related coronaviruses, including SARS-CoV-2.

Suitable samples are : Naso- & Oropharyngeal Swabs, Sputum, Bronchoalveolar Lavage Fluid, Environmental Samples

Note : For confirmation of positive results, we offer the ViroGene® SARS-CoV-2 Confirmation Kit, which contains a SARS-CoV-2 specific detection to exclude the detection of closely related SARS-related viruses.

Technology	real-time PCR
Type of analysis	Qualitative
Target Sequence	specific region in RdRp gene and S gene
Analytical Specificity	SARS-CoV-2, 100 %
Analytical Sensitivity (LoD with 95% probability)	reaches up to 1.0 cp/μl using UNI PCR program (material quantified on standard 1 (SARS CoV (Frankfurt 2003, EVAg,. Corman)) reaches up to 5.0 cp/μl using COVID SCREEN program (material quantified on standard 1 (SARS CoV (Frankfurt 2003, EVAg,. Corman)) reaches up to 1.0 cp/μl using UNI PCR program on synthetic positive control
Extraction/Inhibition Control	PCR inhibition and RNA extraction efficiency control
Validated Specimen	swab, transport medium
Storage	-20 ± 5 °C
Validated Extraction Methods	Magcore NA16 Nucleic Acid Extraction System ViroGene Viral RNA/DNA Extraction kit ViroGene Viral RNA Extraction kit
Instruments	Applied Biosystems 7500 Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System LineGene 9600 Plus SLAN® Real-Time PCR System
Required Detection Channels	FAM, HEX
Regulatory Status	CE IVD