Heat-inactivated SARS-CoV-2, Omicron variant

VR-3347HK ^™

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This product is a preparation of Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) strain USA/GA-EHC-2811C/2021 (Omicron variant) that has been inactivated by heating at 65°C for 30 minutes and is therefore unable to replicate. This heat-inactivated preparation is whole-genome sequenced and can be used as a process control in the development of SARS-CoV-2 molecular diagnostic tools and can also be used to make a dilution series to estimate the level of SARS-CoV-2 detection.

Due to the dynamic nature of lineage determination using PANGO, it is recommended to confirm the provided GISAID information prior to initiation of work.

Product category: Viruses
Product type: Animal virus

Inactivated organism
Classification: Coronaviridae, Betacoronavirus, Severe acute respiratory syndrome-related coronavirus 2
Strain designation: USA/GA-EHC-2811C/2021
Common name: SARS-CoV-2
Genome sequenced strain: Yes
Isolation source: Human; December 12, 2021
Geographical isolation: United States; Georgia
Applications: Assay development

Infectious disease research

Respiratory disease research

Zoonotic disease research
Product format: Frozen
Shipping information: Each vial contains approximately 0.25 mL of heat-inactivated, clarified cell lysate and supernatant from Calu-3 cells infected with SARS-CoV-2 strain USA/GA-EHC-2811C/2021. The vial should be centrifuged prior to opening.
Storage conditions: -70°C or colder

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Documentation

Product sheet

BSL 1

ATCC determines the biosafety level of a material based on our risk assessment as guided by the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL), U.S. Department of Health and Human Services. It is your responsibility to understand the hazards associated with the material per your organization’s policies and procedures as well as any other applicable regulations as enforced by your local or national agencies.

ATCC highly recommends that appropriate personal protective equipment is always used when handling vials. For cultures that require storage in liquid nitrogen, it is important to note that some vials may leak when submersed in liquid nitrogen and will slowly fill with liquid nitrogen. Upon thawing, the conversion of the liquid nitrogen back to its gas phase may result in the vial exploding or blowing off its cap with dangerous force creating flying debris. Unless necessary, ATCC recommends that these cultures be stored in the vapor phase of liquid nitrogen rather than submersed in liquid nitrogen.

General

Specific applications: Assay development
Assay control
Research
This product is intended for use in molecular assays or as a process control (e.g., viral RNA extraction through qPCR amplification process). ATCC VR-3347HK can also be used to make a dilution series to estimate level of SARS-CoV-2 detection.

Characteristics

Comments

This isolate is lineage BA.1 (Pango v.3.1.19 2022-01-20), Omicron (BA.1-like) (Scorpio), and GISIAD clade GRA using the Phylogenetic Assignment of Named Global Outbreak lineages (PANGO) tool. Due to the dynamic nature of lineage determination using PANGO, discrepancies may exist between vial labels and the current lineage assignment. Previous iterations of PANGO identified this isolate as lineage B.1.1.529.

The complete genome of the clinical isolate of SARS-CoV-2, USA/GA-EHC-2811C/2021 has been sequenced (GISAID: EPI_ISL_7171744). The following mutations are present in the clinical isolate: Spike A67V, Spike D614G, Spike D796Y, Spike E484A, Spike G142D, Spike G339D, Spike G446S, Spike G496S, Spike H69del, Spike H655Y, Spike ins214EPE, Spike K417N, Spike L212I, Spike L981F, Spike N211del, Spike N440K, Spike N501Y, Spike N679K, Spike N764K, Spike N856K, Spike N969K, Spike P681H, Spike Q493R, Spike Q498R, Spike Q954H, Spike S371L, Spike S373P, Spike S375F, Spike S477N, Spike T95I, Spike T478K, Spike T547K, Spike V70del, Spike V143del, Spike Y144del, Spike Y145del, Spike Y505H, E T9I, M A63T, M D3G, M Q19E, N E31del, N G204R, N P13L, N R32del, N R203K, N S33del, NSP3 A1892T, NSP3 K38R, NSP3 L1266I, NSP3 S1265del, NSP4 T492I, NSP5 P132H, NSP6 G107del, NSP6 I189V, NSP6 L105del, NSP6 S106del, NSP12 P323L, NSP14 I42V. It was labelled as variant of concern (VOC) Omicron by the World Health Organization (WHO).

The long-term stability of this preparation is not known at this time. It is recommended that users confirm the activity of the product if not used within three months of receipt.

Handling information

Handling notes

Due to high demand, this product is limited to 20 vials per organization per 60 days.

The long-term stability of this preparation is not known at this time. It is recommended that users confirm the activity of the product if not used within three months of receipt.

Quality control specifications

Volume: 250 μL
Verification method: Whole-genome Sequencing

History

Depositors: Centers for Disease Control and Prevention (CDC)
Type of isolate: Human
Year of origin: 2021

Legal disclaimers

Intended use

This product is intended for laboratory research use only. It is not intended for any animal or human therapeutic use, any human or animal consumption, or any diagnostic use.

Warranty

The product is provided 'AS IS' and the viability of ATCC^® products is warranted for 30 days from the date of shipment, provided that the customer has stored and handled the product according to the information included on the product information sheet, website, and Certificate of Analysis. For living cultures, ATCC lists the media formulation and reagents that have been found to be effective for the product. While other unspecified media and reagents may also produce satisfactory results, a change in the ATCC and/or depositor-recommended protocols may affect the recovery, growth, and/or function of the product. If an alternative medium formulation or reagent is used, the ATCC warranty for viability is no longer valid. Except as expressly set forth herein, no other warranties of any kind are provided, express or implied, including, but not limited to, any implied warranties of merchantability, fitness for a particular purpose, manufacture according to cGMP standards, typicality, safety, accuracy, and/or noninfringement.

Disclaimers

This product is intended for laboratory research use only. It is not intended for any animal or human therapeutic use, any human or animal consumption, or any diagnostic use. Any proposed commercial use is prohibited without a license from ATCC.

While ATCC uses reasonable efforts to include accurate and up-to-date information on this product sheet, ATCC makes no warranties or representations as to its accuracy. Citations from scientific literature and patents are provided for informational purposes only. ATCC does not warrant that such information has been confirmed to be accurate or complete and the customer bears the sole responsibility of confirming the accuracy and completeness of any such information.

This product is sent on the condition that the customer is responsible for and assumes all risk and responsibility in connection with the receipt, handling, storage, disposal, and use of the ATCC product including without limitation taking all appropriate safety and handling precautions to minimize health or environmental risk. As a condition of receiving the material, the customer agrees that any activity undertaken with the ATCC product and any progeny or modifications will be conducted in compliance with all applicable laws, regulations, and guidelines. This product is provided 'AS IS' with no representations or warranties whatsoever except as expressly set forth herein and in no event shall ATCC, its parents, subsidiaries, directors, officers, agents, employees, assigns, successors, and affiliates be liable for indirect, special, incidental, or consequential damages of any kind in connection with or arising out of the customer's use of the product. While reasonable effort is made to ensure authenticity and reliability of materials on deposit, ATCC is not liable for damages arising from the misidentification or misrepresentation of such materials.

Please see the material transfer agreement (MTA) for further details regarding the use of this product. The MTA is available at www.atcc.org.

Permits & Restrictions

Import Permit for the State of Hawaii

If shipping to the U.S. state of Hawaii, you must provide either an import permit or documentation stating that an import permit is not required. We cannot ship this item until we receive this documentation. Contact the Hawaii Department of Agriculture (HDOA), Plant Industry Division, Plant Quarantine Branch to determine if an import permit is required.

MORE INFORMATION ABOUT PERMITS AND RESTRICTIONS

References

Curated Citations

Rambaut A, et al. A Dynamic Nomenclature Proposal for SARS-CoV-2 Lineages to Assist Genomic Epidemiology. Nat Microbiol 5: 1403-1407, 2020. PubMed: 32669681

Mercatelli D and Giorgi FM. Geographic and Genomic Distribution of SARS-CoV-2 Mutations. Front Microbiol: doi.org/10.3389/fmicb.2020.01800, 2020. PubMed: 32793182

Gralinski LE and Menachery VD. Return of the Coronavirus: 2019-nCoV. Viruses 12: 135, 2020. PubMed: 31991541

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