Mutation Detection Kits

Ruo Kits

For Detection of Mutations Only

The DIAGNOVITAL® SARS-CoV-2 Mutation Detection Kits (RUO)* are real-time RT-PCR-based tests the detection of SARS-CoV-2 mutations in nasopharyngeal and oropharyngeal swabs and bronchioalveolar lavage respiratory specimens that have been previously extracted and determined to be positive for SARS-CoV-2.

Kit components include ready-to-use PCR master mix along with positive and negative controls. Each kit contains primers and probes for 3 targets:

(1) the specific mutation on the SARS-CoV-2 S gene (e.g., delH69V70),
(2) the wild type allele on the SARS-CoV-2 S gene, and
(3) the human extraction control, RNase P gene.

Assays are designed to use three different detection channels:

(1) FAMTM for the wild type
(2) HEX/VIC for the specific mutation
(3) Cy5 for human extraction control

The DIAGNOVITAL SARS-CoV-2 Mutation Detection kits have been tested on the BioRad CFX96, the Thermofisher/Applied Biosystems Quantstudio 5, and the VERSANT kPCR Molecular System AD (QS5DX) thermal cyclers. Other thermal cyclers that have FAMTM, HEX/VIC and Cy5 channels may also be technically compatible.

Learn more about our products for the detection of SARS-CoV-2 critical mutations and variants.

DIAGNOVITAL® SARS-CoV-2 delH69V70 Mutation Detection Kit (RUO)

For the detection of delH69V70 deletion

DIAGNOVITAL® SARS-CoV-2 E484K Mutation Detection Kit (RUO)

For the detection of delH69V70 deletion

DIAGNOVITAL® SARS-CoV-2 N501Y Mutation Detection Kit (RUO) 

for the detection of delH69V70 deletion

DIAGNOVITAL® SARS-CoV-2 E484Q Mutation Detection Kit (RUO)

For the detection of delH69V70 deletion

*The Diagnovital SARS-CoV-2 Mutation Detection kits are for Research Use Only and meant to be used only with extracted specimens that have previously been diagnosed as SARS-CoV-2 positive using an IVD product.

CE IVD Kits

Multiplex Assays

DIAGNOVITAL®DIAGNO3plex NS SARS-CoV-2 Kit

DIAGNOVITAL® DIAGNO3plex NS SARS-CoV-2 Real Time PCR Kit is a real-time RT-PCR-based diagnostic test for the qualitative detection and discrimination of SARS-CoV-2 and N501Y mutation in respiratory specimens.

Spike protein of wildtype SARS-CoV-2 has Asparagine (N) amino acid at 501th location. SARS-CoV-2 variant has Tyrosine (Y) amino acid at 501th location in Spike protein. This amino acid change in the spike protein causes the strong binding of SARS-CoV-2 to the ACE2. The N501Y mutation is shared by both the alpha and beta variants.

Features

  • Detection of SARS-CoV-2 and N501Y mutation
  • Sample Type: Nasopharyngeal & oropharyngeal swab and bronchoalveolar lavage
  • Target genes:
    • SARS-CoV-2 Nucleocapside (N1) gene
    • SARS-CoV-2 Spike gene (N501Y)
    • Human extraction control RNaseP gene
  • 3 Different Channels: ROX for the SARS-CoV-2, HEX/VIC for the N501Y mutation and the CY5 for the RNAseP (HEC) is detected in the channel
  • Components: PCR master mix, positive and negative controls.
  • Compatible Real Time PCR systems: Roche LightCycler 480, Roche LightCycler 96, Qiagen RotorGene Q, Qiagen Rotor Gene Series, Corbett Realtime PCR, BMS Mic, Biorad CFX Connect, Biorad CFX96, Biorad CFX Touch, Applied Biosystem ABI 7500, Applied Biosystem ABI 7500 Fast, Applied Biosystem ABI StepOne, Applied Biosystem ABI StepOne Plus, Thermo Scientific Quant Studio 5, Slan Realtime PCR, Tianlog Gentier 96E, Tianlong Gentier 96R, Stratagene Mx3500p, Azure Biosystems™ Cielo™ 3 and 6 real-time PCR Systems
  • It is also compatible with any thermal cyclers that have ROX, HEX/VIC and CY5 Channel

DIAGNOVITAL® DIAGNO4PLEX NS SARS-CoV-2 Real Time PCR Test

DIAGNO4PLEX NS SARS-CoV-2 Real Time PCR Test is a real-time RT-PCR-based diagnostic test for the in vitro qualitative detection and discrimination of SARS-CoV-2, wild type N501Y and N501Y mutation in respiratory specimens.

Positive results indicate the presence of SARS-CoV-2 RNA and allow discrimination between N501 and Y501 variants found in the Spike protein. Spike protein of wildtype SARS-CoV-2 has Asparagine (N) amino acid at 501th location define as N501. SARS-CoV-2 variant has Tyrosine (Y) amino acid at 501th location in Spike protein define as Y501. This amino acid change in the Spike protein causes the strong binding of SARS-CoV-2 to ACE2. The N501Y mutation is shared by both the alpha and beta variants.

Features

  • Detection of SARS-CoV-2 and N501Y mutation/wildtype
  • Sample Type: Nasopharyngeal & oropharyngeal swab and bronchoalveolar lavage
  • Target genes:
    • SARS-CoV-2 Nucleocapside (N1) gene
    • SARS-CoV-2 Spike gene (N501Y mutation)
    • SARS-CoV-2 Spike gene (Wildtype allel)
    • Human extraction control RNaseP gene
  • 4 Different Channels: ROX for the SARS-CoV-2, FAM™ for the wildtype allel, HEX/VIC for the N501Y mutation and the CY5 for the RNAseP (HEC) is detected in the channel
  • Components: PCR master mix, positive and negative controls.
  • Compatible Real Time PCR systems: Roche LightCycler 480, Roche LightCycler 96, Qiagen RotorGene Q, Qiagen Rotor Gene Series, Corbett Realtime PCR, BMS Mic, Biorad CFX Connect, Biorad CFX96, Biorad CFX Touch, Applied Biosystem ABI 7500, Applied Biosystem ABI 7500 Fast, Applied Biosystem ABI StepOne, Applied Biosystem ABI StepOne Plus, Thermo Scientific Quant Studio 5, Slan Realtime PCR, Tianlog Gentier 96E, Tianlong Gentier 96R, Stratagene Mx3500p, Azure Biosystems™ Cielo™ 3 and 6 real-time PCR Systems
  • It is also compatible with any thermal cyclers that have FAM™, ROX, HEX/VIC and CY5 Channel