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) FAM™ 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 FAM™, 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.

Download Diagnovital SARS-CoV-2 Mutation Detection Assays
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Poster ECCMID 2022 Diagnovital Mutation Detection Assays


Portfolio of Diagnovital Mutation Detection Kits for identifying SARS-CoV-2 variants





DIAGNOVITAL® SARS-CoV-2 delH69V70 Mutation Detection Kit (RUO) for the detection of delH69V70 deletion

Instruction for use

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DIAGNOVITAL® SARS-CoV-2 E484K Mutation Detection Kit (RUO) for the detection of E484K Mutation

Instruction for use

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DIAGNOVITAL® SARS-CoV-2 N501Y Mutation Detection Kit (RUO) for the detection of N501Y Mutation

Instruction for use

EN ES FR DE IT
DIAGNOVITAL® SARS-CoV-2 E484Q Mutation Detection Kit (RUO) for the detection of E484Q Mutation

Instruction for use

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DIAGNOVITAL® SARS-CoV-2 K417N Mutation Detection Kit (RUO) for the detection of K417N Mutation

Instruction for use

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DIAGNOVITAL® SARS-CoV-2 L452R Mutation Detection Kit (RUO) for the detection of L452R Mutation

Instruction for use

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DIAGNOVITAL® SARS-CoV-2 P681H Mutation Detection Kit (RUO) for the detection of P681H Mutation

Instruction for use

EN ES FR DE IT
DIAGNOVITAL® SARS-CoV-2 P681R Mutation Detection Kit (RUO) for the detection of P681R Mutation

Instruction for use

EN ES FR DE IT
DIAGNOVITAL® SARS-CoV-2 K417T Mutation Detection Kit (RUO) for the detection of K417T Mutation

Instruction for use

EN ES FR DE IT
DIAGNOVITAL® SARS-CoV-2 T478K Mutation Detection Kit (RUO) for the detection of T478K Mutation

Instruction for use

EN ES FR DE IT
*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.