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We understand the risks and worries of going back to school

Knowing that an accurate, accessible test with noninvasive sample collection can make an important contribution to a campus being able to function during the pandemic, Standard BioTools has created the COVID-19 Campus Safeguard Program.

Campus Safeguard provides simple, affordable and accessible testing options as an essential part of your overall testing program to help keep your university or college open. If your campus operates a CLIA-certified lab, Standard BioTools™ will work with you to implement the Advanta™ Dx SARS-CoV-2 RT-PCR Assay.

No lab? No worries! Saliva sample collection, off-campus clinical testing and results reporting to both your administration and your student body can be coordinated by Standard BioTools providers with expertise in delivering laboratory services.

Download a flyer about the COVID-19 Campus Safeguard Program →

Make your campus safer with the Standard BioTools Advanta Dx SARS-CoV-2 RT-PCR Assay

For Use under FDA Emergency Use Authorization (EUA)

As students, faculty and staff return to campus, their health and safety is paramount. Enroll in the Standard BioTools COVID-19 Campus Safeguard Program to access a convenient SARS-CoV-2 test featuring noninvasive saliva collection at economical rates. By enhancing your diagnostic testing capacity, Campus Safeguard Program can help institutions provide a healthy campus for students, faculty and staff with both on-campus and off-campus clinical testing solutions in support of safer classroom, sports, university housing and extracurricular activities.

Get more information about the Advanta Dx SARS-CoV-2 RT-PCR Assay →

Simple sample collection

The assay uses saliva, a noninvasive sample type that is pain-free and convenient to collect.

$5 per test for campus CLIA labs

With a CLIA certified lab on campus, you can test thousands of samples per day for as little as $5 per test*.

End to end COVID-19 testing services

Standard BioTools can facilitate a turnkey solution by connecting you with expert providers of lab services who can coordinate sample collection, off-campus testing and result reporting for up to thousands of samples per day.

		Simple sample collection The assay uses saliva, a noninvasive sample type that is pain-free and convenient to collect.

		$5 per test for campus CLIA labs With a CLIA certified lab on campus, you can test thousands of samples per day for as little as $5 per test*.

		End to end COVID-19 testing services Standard BioTools can facilitate a turnkey solution by connecting you with expert providers of lab services who can coordinate sample collection, off-campus testing and result reporting for up to thousands of samples per day.

Ready to discuss how Standard BioTools can help protect your campus?

With a Biomark HD, you can hit the ground running with PCR-based testing of saliva for COVID-19!

To run the Dx test, you need a Biomark™ HD system placed in the campus CLIA certified lab. Standard BioTools has a large number of Biomark HD placements in academic institutions throughout the US. If you are uncertain whether your institution has a Biomark HD on campus or want to inquire about purchasing the system, contact Standard BioTools.

If you do not have a clinical lab on campus, Standard BioTools can connect you with service providers that have expertise setting up a turnkey, sample-to-answer system that includes sample collection, testing by a CLIA certified clinical laboratory and results reporting.

Standard BioTools stands ready to assist you in getting PCR-based saliva testing for the SARS-CoV-2 virus on your campus swiftly, conveniently and economically.

Collaboration

Standard BioTools collaborated with the Washington University School of Medicine in St. Louis to develop the SARS-CoV-2 saliva test for use under EUA.

Collaboration

Standard BioTools collaborated with the Washington University School of Medicine in St. Louis to develop the SARS-CoV-2 saliva test for use under EUA.

Get more information or sign up for the COVID-19 Campus Safeguard Program

Instructions for Use

Fact Sheet for Patients

Fact Sheet for Healthcare Providers

Advanta Dx SARS-CoV-2 EUA Interpretive Software

Instrument and Software Information

Information for Laboratories about coronavirus

Collecting, Handling and Testing Clinical Specimens for COVID-19

Get facts about coronavirus

COVID-19 Campus Safeguard Program eligibility

* The offer to join the COVID-19 Campus Safeguard Program is valid only for academic institutions in the US from January 1 through March 31, 2021. $5 promotional pricing is for on-campus CLIA certified clinical labs performing the Advanta Dx SARS-CoV-2 RT-PCR Assay and offered through June 2021 if accounts commit to a contractual obligation to purchase and receive a minimum volume of tests before December 31, 2021, if the account requires a Biomark HD instrument. Pricing for off-campus testing depends on the level of service desired and other terms and conditions. Pricing does not apply to instrument pricing, shipping, installation, training, service plans or other consumables. No additional discounts apply with this promotion. This offer does not apply to private clinical laboratories and public health laboratories. Learn more at fluidigm.com/covid-19-campus.

Intended Use

The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time reverse transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their health care provider.

Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high-complexity tests.

This test is also for use with saliva specimens that are self-collected at home with or without the supervision of a health care provider (HCP) with the AZOVA COVID-19 Test Collection Kit from individuals suspected of COVID-19 by their HCP.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with individual history and other diagnostic information is necessary to determine individual infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for individual management decisions. Negative results must be combined with clinical observations, individual history, and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

For In Vitro Diagnostic Use. For Use Under Emergency Use Authorization Only. Rx Only.

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 pathogen.

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.

Information in this publication is subject to change without notice.

Patent and license information: fluidigm.com/legal/notices.

Trademarks: Standard BioTools, the Standard BioTools logo, Fluidigm, the Fluidigm logo, Advanta and Biomark are trademarks and/or registered trademarks of Standard BioTools Inc. (f.k.a. Fluidigm Corporation) in the United States and/or other countries. All other trademarks are the sole property of their respective owners.