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  2. Diagnóstico de Laboratorio
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  4. Ensayos de Diagnóstico In Vitro (IVD)
  5. Ensayo FTD SARS-CoV-2 1
  6. Emergent SARS-CoV-2 Variants
COVID-19 variants

Emergent SARS-CoV-2 Variants

Discrimination of Omicron from Delta and other variants

Surveillance Program

As the SARS-CoV-2 is continuously mutating and multiple SARS-CoV-2 variants are circulating globally, Siemens Healthineers has an active surveillance program in place. We continue to monitor the literature and the GISAID database to assess for new variants with the potential to affect the performance of the FTD SARS-CoV-2 Assay.1 

This update is based on in silico analysis from December 8, 2021 of 4,642,494 complete sequences for the ORF1ab target and 4,637,780 complete sequences for the N gene target of SARS-CoV-2 from the GISAID database (www.gisaid.org).

Variants list and country of origin regarding SARS-CoV-2

Main variants and clades that have been confirmed as detected2

WHO label

PANGO Lineage

GISAID clade

Nextstrain clade

Alternate name

Country/ region of origin

Variants of Concern (VOC)

Alpha

B.1.1.7

GR/501Y.V1

20I/501Y.V1

VOC-202012/01

U.K.

Beta

B.1.351

GH/501Y.V2

20H/501Y.V2

VOC-202012/02

South Africa

Gamma

P1

GR/501Y.V3

20J/501Y.V3

VOC-202101/02

Brazil

Delta

B.1.617.2

G/478K.V1

21A

/

India

Omicron

B.1.1.529

GR/484A

21K

/

Multiple Countries

Variants of interest (VOI)3

Lambda

C.37

GR/452Q.V1

20D

/

Peru

Mu

B.1.621

GH

21H

/

Colombia

Variant Testing Workflow 

Omicron Positive Identification Reflex Testing Workflow

Eluates of positive SARS-CoV-2 samples are reflex-tested with Diagnovital L452R (RUO)4 and Diagnovital K417N (RUO)4 assays to help discriminate between Delta variant and Omicron variant suspected samples.

Click through the graphic below to learn more.

Diagnosis
 

SARS-CoV-2 Detection

Profiling
 

Mutation Profiling

Sequencing
(optional)

Complete Analysis of the Viral Genome

  1. Diagnosis

    Sensitive detection of SARS-CoV-2 RNA from respiratory samples using RT-PCR SARS-CoV-2 diagnostic test

  2. SARS-CoV-2 Detection

    SARS-CoV-2 detection using sensitive RT-PCR diagnostic test

  3. RT-PCR Assays (RUO)*

    Selected SNP assays for likely identification of Omicron and likely exclusion of Delta using leftover eluate


    *Research use only (RUO), not for use for clinical or diagnostics purposes.

  4. Mutation Profiling

    Reflex test using selected SNP assays* for the likely identification of Omicron variant and likely exclusion of Delta variant by mutation profiling


    *Research use only (RUO), not for use for clinical or diagnostics purposes.

  5. Sequencing (optional)

    Sequencing of selected Omicron suspected samples

  6. Complete Analysis of Virtual Genome

    Confirmation of suspected Omicron samples by sequencing (optional)

Collaboration with A1 Life Sciences to Track Variants

Now offering A1 Life Sciences' Diagnovital kits

Diagnovital kits are designed to detect and identify SARS-CoV-2 mutations and variants. The portfolio of A1 Life Sciences‘ Diagnovital kits will complement the FTD SARS-CoV-2 Assay, which is intended for the initial diagnosis of the infection. A1 Life Sciences’ Diagnovital portfolio, as distributed by Siemens Healthineers, will be offered for Research Use Only around the world.

a representation of covid-19 variants with viruses colored differently

SARS-CoV-2 Mutation Profiling

Since the beginning of the pandemic, SARS-CoV-2 has continued to mutate, resulting in genetic variations in the population of circulating strains of the virus. A new variant of SARS-CoV-2 may have one or more mutations that differentiate it from the predominant virus variants already circulating in the population.

This table shows the major amino acid substitutions in the Spike protein for the variants of concern (VOC), variants of interest (VOI), and other variants under monitoring.

a table as of january 2022 of sars-cov-2 variants and mutation profiling

FTD SARS-CoV-2 Assay regulatory status and reaction sizes

The FTD SARS-CoV-2 Assay has been confirmed to detect the main variants and clades of SARS-CoV-2 that are currently circulating with a 100% detection rate.

Product Description
Siemens Material Number
FTD SARS-CoV-2 Assay - CE-IVD (32 reactions)
11416300
FTD SARS-CoV-2 Assay - CE-IVD (96 reactions)5
11416284
FTD SARS-CoV-2 Assay EUA1 (96 reactions)5
11416302

1

CE-IVD labelled for diagnostic use in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

2

Data on file at Fast Track Diagnostics, A Siemens Healthineers Company, Luxembourg. Data current as of May 2021.

3

The Epsilon, Zeta and Theta variants are no longer considered VOI by the WHO (https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/). 

4

Research use only (RUO), not for use for clinical or diagnostics purposes.

5

88 reactions, when automated on the VERSANT kPCR Molecular System.