Fluidigm | COVID-19 Community Connect Program

Connecting you
with COVID-19
testing services
you need.

Protect your workforce, customers and guests with a PCR-based COVID-19 saliva test

The evolving pandemic has profoundly impacted a wide swath of industries across the world, leading to business interruptions and loss of revenue. Access to simple, affordable and reliable COVID-19 testing is absolutely necessary for business continuity. To address this fundamental need, Standard BioTools™ has created the COVID-19 Community Connect Program. Community Connect provides access to turnkey COVID-19 testing services as well as a direct testing capability if your institution has a lab certified under the Clinical Laboratory Improvement Amendments (CLIA).

Community Connect links workforces across the nation to products and services designed to support the specific testing requirements and objectives of your organization, including timely implementation. Whether conducted in-house or via our network of CLIA certified labs, the testing employs the Standard BioTools Advanta™ DX SARS-CoV-2 RT-PCR Assay* using a small amount of saliva. Saliva is a noninvasive, easy-to-collect sample type that does not require extraction materials, which have been in short supply. Through this program, Standard BioTools seeks to help businesses respond to the COVID-19 outbreak, protect their workforces, customers and guests, shore up their business and begin rebuilding their bottom line and the national economy.

* The assay has been authorized for use in accordance with FDA guidelines for Emergency Use Authorization.

How does Community Connect work?

There are two ways to obtain COVID-19 diagnostic testing for your organization using the Advanta Dx SARS-CoV-2 RT-PCR Assay.

Send-out (services): If you want to outsource your testing to a CLIA certified lab, Standard BioTools providers with expertise in delivering lab services can provide end-to-end COVID-19 testing by coordinating sample collection at your business, offsite clinical testing and HIPAA compliant clinical reporting.
In-house testing (products): If you prefer to do your testing in-house, Standard BioTools supports testing in your own CLIA certified laboratory with the Biomark™ HD instrument platform and the Advanta Dx SARS-CoV-2 RT-PCR Assay reagent kit. We have the equipment, knowledge and manpower to get you up and running in weeks.

By implementing saliva-based COVID-19 testing through Standard BioTools products and services, you can achieve the capacity to test from hundreds to thousands of samples per day using PCR technology. You also gain peace of mind that comes from knowing the test is accurate and supports detection of new strains of coronavirus.

Performance on emerging strains

Standard BioTools conducts in silico analysis to determine the effectiveness of the Advanta Dx SARS-CoV-2 RT-PCR Assay design in detecting new strains of the virus as they emerge. To date, analysis has been conducted for the following strains: SARS-CoV-2 VUI-202012/01 (or B.1.1.7), 20C/501Y.V2 (or B.1.351), B.1.1.248, B.1.1.28, Lineage P.1 and COH32. Results indicate that the Advanta Dx Assay design supports detection of these new coronavirus strains. None of the genetic variants in these strains are in regions of the viral genome targeted by the assay’s primers and probes.

Contact us today to learn more about Standard BioTools end-to-end service offerings or how Standard BioTools can help you begin using the Advanta Dx SARS-CoV-2 RT-PCR Assay in your own clinical lab.

Saliva-based testing

Standard BioTools has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus. The assay does not require collection via invasive nasopharyngeal swab. The company’s clinical study submitted to the FDA demonstrated 100 percent agreement between saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and results from paired nasopharyngeal samples tested with authorized assays.

By implementing saliva-based COVID-19 testing through Standard BioTools products and services, you can achieve the capacity to test from hundreds to thousands of samples per day using PCR technology. And you gain the peace of mind that comes from knowing the test is accurate and supports detection of new strains of coronavirus.

Learn more

Get more information or sign up for the program

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.

Unless explicitly and expressly stated otherwise, all products are provided for Research Use Only, not for use in diagnostic procedures. Find more information here.