Vitassay qPCR kit for the detection of SARS-CoV-2

SARS-Cov-2

Real-time PCR kit for the qualitative detection of SARS-CoV-2 in clinical samples.

Vitassay qPCR SARS-CoV-2 allows the qualitative detection of 2019 Novel Coronavirus (SARS-CoV-2) by real-time RT-PCR in clinical samples. The product is intended for use in the diagnosis of SARS-CoV-2 infections alongside clinical data of the patient and other laboratory tests outcomes.

Vitassay qPCR SARS-CoV-2 is a ready to use test which contains in each well all the necessary reagents for real-time PCR assay in a stabilized format. In addition, an internal control allows the detection of a possible reaction inhibition.

For the Vitassay qPCR SARS-CoV-2, the amplification of the target sequence ORF1ab gene is detected through the FAM channel, the amplification of the target sequence N gene is detected through the ROX channel whereas the internal control (IC) in HEX, VIC or JOE channel (depending on the equipment used).

Vitassay qPCR SARS-CoV-2 is based on the real-time amplification of specific conserved fragments of the ORF1ab and N genes encoded by the SARS-CoV-2.

The viral RNA extracted is transcribed into cDNA using a specific primer by reverse transcription step followed immediately in the same well by polymerase chain reaction. The presence of SARS-CoV-2 is detected by an increase in observed fluorescence during the reaction upon hydrolysis of the fluorescent probe.

Vitassay qPCR SARS-CoV-2 is a ready-to used test which contains in each well all the necessary reagents for real-time PCR assay in a stabilized format. In addition, an internal control allows the detection of a possible reaction inhibition.

1. Resuspend
2. Add the sample
3. Fit the cover
4. Place in cycler
5. Interpret results

Vitassay qPCR SARS-CoV-2 has a detection limit of ≥10 viral RNA copies per reaction and has been validated for use on the following instruments:

  • Cobas Z480 (Roche)
  • 7500 Fast Real-Time PCR System (Applied Biosystems)
  • StepOne™ Real-Time PCR System (Applied Biosystems)
  • CFX96 ™ Real-Time PCR Detection System (Bio-Rad)
  • AriaMx Real-Time PCR System (Agilent Technologies)
  • DTlite Real-Time PCR System (DNA-Technology)
  • DTPrime Real Time Detection Thermal Cycler (DNA-Technology)
  • Rotor-Gene® Q (Qiagen)
  • SmartCycler® (Cepheid)

For Rotor-Gene® Q and SmartCycler® thermocyclers the product should be reconstituted following the procedure and transferred into specific Rotor-Gene® Q and/or SmartCycler tubes.

When using the Applied Biosystems 7500 Fast with strips it is recommend to place a plate holder for the tubes (Ref. PN 4388506).

CE IVD marked kit.