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16th February 2021  Product update: rapidvirology staff writer

SARS-CoV-2 Assay Kit Screens Positives for Common 69-70 del Mutation Among Variants


Applied DNA Sciences, Inc. and Cytocheck Laboratory, LLC (Cytocheck), have reported the first instance of a SARS-CoV-2 variant in Kansas that was subsequently confirmed as lineage B.1.1.7 (the “UK variant”) by the Kansas Department of Health and Environment (KDHE) on February 3, 2021.

Cytocheck utilizes Applied DNA’s Linea™ COVID-19 Assay Kit (the “Assay Kit”) in a genomic surveillance modality that screens virus-positive samples for the 69-70del mutation found in several variants, including the UK variant, that is characterized by increased transmissibility.

Genomic surveillance seeks to monitor positivity for variant spread to inform public health decisions. The lack of gene sequencing capacity in the U.S. with which to confirm variant spread is creating demand for tools to supplement and strengthen the sequencing capacity of participating laboratories nationally.

Using the Assay Kit's S-gene dropout in the presence of certain SARS-CoV-2 mutations, laboratories like Cytocheck can use Applied DNA’s Assay Kit to identify virus-positive samples that may be a SARS-CoV-2 variant.

Once identified, those samples then undergo gene sequencing at participating laboratories, thereby making more rational use of limited gene sequencing capacity. Applied DNA believes that the multi-S-gene-target design of its Assay Kit gives it a substantial advantage in the detection of certain variants.

“The UK and Denmark have successfully used a molecular test that experiences S-gene dropout in the presence of the 69-70del mutation to deploy mass genomic surveillance to inform their public health decisions. We believe our Assay Kit, which experiences similar S-gene dropout, can set the same standard for genomic surveillance in the U.S.,” stated Dr. James A. Hayward, president and CEO, Applied DNA.

Commenting on the first detection of the UK variant in Kansas, Cytocheck President and Medical Director Dr. Ron Leonard, stated, “We are uniquely positioned to assist in the surveillance of emerging SARS-CoV-2 variants as we receive COVID-19 specimens for testing from three States

"Integral to our workflow was bringing on an additional assay, the Applied DNA Linea™ COVID-19 Assay Kit, to screen our positive cases specifically looking for “S-gene drop out” which could indicate a potential UK variant. Within the first 30 samples screened, a case with S-gene drop out was identified, sent to the KDHE laboratory for sequencing and confirmed to be the first B.1.1.7 variant found in Kansas,” said Leonard. 

Linea™ COVID-19 Assay Kit
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.


    

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Date Published: 16th February 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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