AzureSeq Yale Saliva Direct

One Step Universal RT-qPCR Kit
For Qualitative Detection of SARS-CoV-2 in Saliva

Robust, easy to use RT-qPCR SARS-CoV-2 assay for saliva samples in an American-made product. Works across a wide range of thermal cyclers. All enzymes, probes, and primers are synthesized in the United States. Use up to 5 pooled samples. Controls sold separately.

Detect SARS-CoV-2
in Saliva Without Extraction

Intended for Use in Symptomatic & Asymptomatic Individuals

Made in America
Emergency Use Authorization*

Saliva is collected without preservative in a sterile container and is heat-inactivated with and without Proteinase K.

Detects SARS-CoV-2 nucleic acid in up to 5 individual samples.

3-6 copies/ul depending on instrument. Ct cutoff dependent on instrument.

CFX96 Touch Real-Time PCR Detection System
CFX384 Touch Real-Time PCR Detection System
Applied Biosystems StepOne Real-Time PCR System
Applied Biosystems StepOne Plus Real- Time PCR System
Applied Biosystems 7500 Fast Real-Time PCR System
Applied Biosystems 7500 Fast Dx Real-Time PCR System
ABI QuantStudio 5 Real-Time PCR system (96 or 384 well format)
ABI QuantStudio 6 Real-Time PCR system (96 or 384 well format)
ABI QuantStudio 7 Pro Real-Time PCR system (96 or 384 well format)
ABI QuantStudio 7 Flex Real-Time PCR system (96 or 384 well format)
ABI QuantStudio 12K Flex Real-Time PCR system (384 well format)
ABI QuantStudio Dx Real-Time PCR system (96 well format)
Liberty16
Cobas Z480
LightCycler 480
Open qPCR
qTower
AriaMX Real-Time PCR System

* Manufactured and Distributed Under Authorized License from Bantek, Inc. Only for Use by SalivaDirect™ Registered Yale Facilities under Emergency Use Authorization

AzureSeq Yale Saliva Direct

This dualplex assay detects the N1 region on the SARS-CoV-2 nucleocapsid gene and Human Ribonuclease P as a sample control.

Click Here for Current Protocol

Targets

N1 Region SARS-CoV-2 nucleocapsid plus Human Ribonuclease P gene

Sample

Saliva without preservative in sterile collection device

Dyes

N1=FAM
RP= ROX

LoD

3-6 copies/ul dependent on instrument & protocol

ORDERING INFORMATION

Product SKU#
AzureSeq Yale Saliva Direct, 200 Reactions SB-ASDS-200
AzureSeq Yale Saliva Direct, 1000 Reactions SB-ASDS-1000

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Laboratories must be located in the United States and have personnel appropriately trained in RT-PCR techniques and using personal protective equipment.

Contact Us for More Information

Getting Started

Getting started with AzureSeq Direct Saliva is straightforward:

  • Contact SeqOnce Biosciences for an AzureSeq Direct Saliva evaluation kit and controls.

  • Register with Yale School of Public Health to become an authorized lab.

  • Generate and submit CLIA verification data running the AzureSeq Direct Saliva protocol on 5 negative and 5 positive SARS-CoV-2 saliva samples.

  • Fill out and submit Authorized Laboratory Agreement with Yale University. Learn more about the Designation Process here.

* Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Laboratories must be located in the United States and have personnel appropriately trained in RT-PCR techniques and using personal protective equipment.

No. The controls are ordered as a separate sku and come pre-diluted, ready for use.

Yes- the kit is licensed from Bantek, Inc. which has an authorized license from Yale SalivaDirect™ to manufacture the SalivaDirect assay components.

According to the Yale University website (January 21, 2021):

The SalivaDirect team is currently validating or planning to validate the following PCR instrumentation: AriaMX, CFX384, QuantStudio 5 (96 and 384), QuantStudio 6 (96 and 384), QuantStudio 7 (96 and 384), QuantStudio 12k. The SalivaDirect team is NOT planning to validate otherwise fully automated RNA extraction and PCR platforms. We are prioritizing separate PCR instrumentation as they permit greater flexibility to laboratories including more cost-effective reagents.

  • CFX96 Touch Real-Time PCR Detection System
  • CFX384 Touch Real-Time PCR Detection System
  • Applied Biosystems StepOne Real-Time PCR System
  • Applied Biosystems StepOne Plus Real- Time PCR System
  • Applied Biosystems 7500 Fast Real-Time PCR System
  • Applied Biosystems 7500 Fast Dx Real-Time PCR System
  • ABI QuantStudio 5 Real-Time PCR system (96 or 384 well format)
  • ABI QuantStudio 6 Real-Time PCR system (96 or 384 well format)
  • ABI QuantStudio 7 Pro Real-Time PCR system (96 or 384 well format)
  • ABI QuantStudio 7 Flex Real-Time PCR system (96 or 384 well format)
  • ABI QuantStudio 12K Flex Real-Time PCR system (384 well format)
  • ABI QuantStudio Dx Real-Time PCR system (96 well format)
  • Liberty16
  • Cobas Z480
  • LightCycler 480
  • Open qPCR
  • qTower
  • AriaMX Real-Time PCR System

Yes. Fill out and submit Authorized Laboratory Agreement with Yale University. Learn more about the Designation Process here.

FAM and ROX

DOING OUR PART

By highlighting threatened or endangered species, SeqOnce hopes to draw attention to conservation efforts. As biologists, we believe humanity is better served when ecologies are maintained and there is diversity of life.

SeqOnce supports protecting and conserving endangered and threatened species.

Learn More Here

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