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2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2

2019-nCoV CDC-qualified Probe and Primer Kits for SARS-CoV-2

The kits include FAM-BHQ probes and primers mixed into a single assay per signature as required by protocols provided by the CDC.

Please note: this product will be discontinued on September 30, 2021.

Why are we discontinuing it?

After December 31, 2021, the CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of EUA200001, CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The CDC decided to discontinue support for this assay due to the availability of commercial options for clinical diagnosis of SARS-CoV-2 infection, including multiplexed and high-throughput options. Visit www.fda.gov for a list of authorized COVID-19 diagnostic methods.

Until what date can I use the product?

The 2019-nCoV CDC-qualified Probe and Primer Kit can be purchased from LGC Biosearch until September 30, 2021

For clinical testing, the kit can be used under the EUA for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel until December 31, 2021.

For RUO or IVD use outside of FDA jurisdiction, the kit may be used up to the expiry date of each lot (please note: lot 144604 expires on 2 April 2022, and lots 143503, 143764, 144000 expire in March of 2022).

Do you have alternative products?
Please see our ValuPanel oligonucleotides for recommended RUO alternatives for non-clinical testing:

  • 2019-nCoV ValuPanel Reagents
    Separately delivered primers and probes that are the same as those found in the 2019-nCoV CDC-qualified Probe and Primer Kit. For Research Use Only. Not for use in diagnostic procedures.
  • Influenza SARS-CoV-2 Multiplex ValuPanel Reagents.
    Separately delivered primers and probes that may be used for a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses. For Research Use Only. Not for use in diagnostic procedures.
  • Each lot of the probe and primer set is released for distribution by CDC testing results
  • Product in stock ships same or next business day
  • From the trusted inventor and original source of Black Hole Quencher™ (BHQ™) technology referenced in US CDC protocols
  • Proven track record supporting public health crises with the expertise to rapidly scale up
  • Now the only approved commercial supplier of the 2019-nCoV CDC-qualified Probe and Primer Kit labeled with BHQ™ dye

reactions: 1000

Item ID KIT-NCOV-PP1-1000
TBD
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Product information

The kits include FAM-BHQ probes and primers mixed into a single assay per signature as required by protocols provided by the CDC.

The following CDC-qualified lots of 2019-nCoV CDC Probe and Primer Kits are available: 143503, 143764, 144000, 144604

NOTE: This product is intended for laboratory professionals and is not a direct-to-consumer test.

 

Emergency Use Authorization Protocols and FAQs 

 

Research Use Only COVID-19 Protocols, Primers, and Probes

 

For Research Use Only. Not for use in diagnostic procedures.

The 2019-nCoV CDC-qualified Probe and Primer Kit for SARS-CoV-2 is intended to be used in conjunction with methods and reagents defined in the Instructions for Use outlined in the re-authorized EUA, CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel.

Please review the below items listed in Section FF of the EUA

  • 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 2019-nCoV, not for any other viruses or pathogens, and;

  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. ยง 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The customer shall be solely responsible for making sure that the way any products supplied are used are in compliance with all applicable laws and regulations, and to obtain any necessary regulatory approvals and/or intellectual property rights that may be required for the customer's intended use.

Type Kits

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