Omicron-specific PCR test for Variant of Concern Screening  

Rapid screening in a single reaction:
-   SARS-CoV-2 infection status
-  VoXcreen and VoXident Kits
-   Variant of concern identification  (Omicron or Delta VoC)

Omicron-specific PCR Test

Omicron-specific PCR Test

Regular price
$990.00 USD
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$990.00 USD
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VoXcreen qPCR assays

Our Omicron-specific PCR test robustly targets distinct deletions in the genome of the the new Omicron Variant of Concern. It thereby efficiently singles out the omicron variant for determination.

The assay is available as single- or multiplex assay.

For fastest results, our new multiplex assay “VoXcreen” differentiates in a single PCR reaction between the Omicron and Delta variants of concern (VoCs). Since Omicron and Delta together represent more than 99% of SARS-CoV-2 cases in most countries, VoXcreen directly identifies the VoC for nearly all positive samples in a single PCR. For the identification of rare non-Delta and non-Omicron variants, our “Alpha, Beta, Gamma” assay can be performed as follow-up PCR. All our products are for Research use Only (RUO) - not for use in diagnostic tests. 

The VoXcreen assay targets the N1-Gene, common in all SARS-CoV-2, using a WHO-recommended assay design. Therefore, both Omicron and Delta variants are identified with the recommended dual-target strategy. The assay also contains an internal isolation control (RP).

Current tests need at least two separate PCR reactions and often also genome sequencing for the specific identification of the Omicron VoC. Our test identifies Omicron reliably in a single PCR reaction. This saves time and liberates PCR-capacities that are critically needed for high-throughput sample screening. 

Our Omicron-specific assay is also available as single assay with fluorophores of your choice and as primer-probe mix.

For all other SARS-CoV-2 related products including PCR- tests for specific mutations to determine the Lambda, Mu, C.1.2 as well as other VoCs and VoIs, please contact us.

SARS-CoV-2 qPCR Analyses
PCR Testing and VoC Indentification Procedure

Above:
A) VoC-Identification after screening PCR: positive samples need to be searched for in the freezer for secondary PCR or sequencing. Sample mixing possible. RNA may already be degraded due to more freeze-thaw cycles. Follow-up PCRs need time and sequester urgently needed PCR capacities.
B) GenXPro VoXcreen PCR identify VoCs during screening PCR to save time, resources and to free PCR capacities.

Omicron VoC
Delta VoC

Above: PCR results of VoXcreen assay from Omicron- and Delta VoCs

PCR Results of VoXcreen-DO assay from Omicron- and Delta VoCs

Above:   Omicron genome of SARS-CoV-2 with accumulations of mutations in S-Gene.

Evaluation Scheme

Above:   Evaluation scheme of our VoXcreen assay for simultaneous dual-target SARS-CoV2 identification and VoC-determination in a single assay.

The kits are designed and extensively tested in Germany and are manufactured in the US with components from Germany and the US.

All assays are strictly for Research Use Only. Not for use in any diagnostic procedure - these assays are not FDA approved. Kits are for internal testing by qualified laboratories. CE certification process pending.



Code of Federal Regulations Title 21

Sec. 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.

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