SARS-Coronavirus 2 Confirmation, CE IVD, RT-PCT Kit

ViroGene® SARS-CoV-2 Confirmation RTU is a CE IVD labeled human diagnostic kit for the confirmation of samples tested positive for SARS coronavirus 2 using the ViroGene® SARS-CoV-2 Screening RTU Kit.

This kit is one 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.

The ViroGene® SARS-CoV-2 Confirmation Kit contains SARS-CoV-2 specific detection to exclude closely related SARS-related viruses.

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

Note : For screening of unknown samples in a first step, we offer the ViroGene® SARS-CoV-2 Screening Kit.

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