Clinical Labs

Join the SalivaDirect designated lab network!

SalivaDirect is a PCR test that uses saliva to detect SARS-CoV-2. Our flexible, extraction-free method is designed to be a cost-effective and easy-to-use option for laboratories, enabling them to achieve higher throughput and faster results.

We invite laboratories across the U.S. to join our network designated to conduct testing under the SalivaDirect Emergency Use Authorization (EUA). The comprehensive Instructions for Use include full asymptomatic labeling, a variety of reagents and instruments, alternative workflows, sample pooling, unsupervised collection, and the use of the SalivaDirect Direct-to-Consumer and At-Home Collection Kits—available for individuals two years and older. *The U.S. FDA granted the SalivaDirect Emergency Use Authorization (EUA 202097) in August 2020. To support pandemic response, FDA also authorized SalivaDirect, Inc. to extend its EUA to CLIA labs across the country.

Interested in offering SalivaDirect?

With all documents in hand, most labs complete the designation process within one week.

Start here:

How SalivaDirect™ is helping communities

Our team at SalivaDirect, Inc. strongly supports access to diagnostic testing.

Labs are invited to join our network of more than 190 laboratories across 41 U.S. states that have been designated to test under the SalivaDirect™ EUA*. The versatile Instructions for Use offered include full asymptomatic labeling, numerous reagents and instruments, alternative workflows, sample pooling, unsupervised collection, as well as use of the SalivaDirect™ Direct-to-Consumer and At-Home Collection Kits – all for individuals two years and older.

*The U.S. FDA granted the SalivaDirect™ Emergency Use Authorization (EUA 202097) in August 2020. To support pandemic response, FDA also authorized the Yale School of Public Health to extend its EUA to other labs.

Interested in offering SalivaDirect?

Laboratory designation process

Clinical laboratories that meet the criteria above and are interested in being designated as authorized laboratories to offer SalivaDirect™ to their consumers as part of their laboratory services under the EUA 202097 must follow these steps:

Step 1

Initial Request for Designation

Step 2

Review and Designation Process

Step 3

Training and Onboarding Process

The SalivaDirect Protocol

The SalivaDirect protocol is authorized for emergency use by the U.S. Food and Drug Administration to diagnose COVID-19 in both symptomatic and asymptomatic individuals.

The SalivaDirect protocol is one of the first diagnostic approaches to offer reagent and instrument-flexible capabilities, allowing labs to use several commercially available reagents and instruments from different suppliers. Validated across a wide range of reagents and instruments, the protocol can be seamlessly integrated into many existing lab setups reducing the barrier to entry for labs to begin providing COVID-19 diagnostic testing.

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

How Does the SalivaDirect Protocol Work?

The SalivaDirect protocol utilizes a nucleic acid extraction-free workflow paired with real-time reverse transcription polymerase chain reaction (RT-PCR) technology to detect SARS-CoV-2 RNA in saliva. The process involves the following steps:

Patients provide a saliva sample by passively drooling into a sterile container or collection tube. Patients are advised not to eat or drink for 30 minutes before sample collection. Saliva self-collection instructions can be accessed here.

The SalivaDirect protocol validated three sample preparation workflow options that utilize a combination of Proteinase K and/or heat pre-treatments. These treatments break down proteins in the saliva and help release viral RNA, thereby removing the need for lengthy and costly RNA extraction steps. Labs are able to use the workflow that best integrates with their operations.

After sample preparation, the sample is analyzed using one-step RT-PCR amplification to detect any SARS-CoV-2 RNA present. Fluorescently labeled primers and probes from various vendors have been evaluated and selected to ensure optimal sensitivity and specificity in detecting viral RNA. Several different PCR instruments have also been validated. See the vendors below.

Technical Requirements

Sample Collection

The SalivaDirect protocol has received EUA approval for three sample collection methods.

Saliva collection is performed in the presence of a trained observer
Saliva collection is performed at home using the SalivaDirect At-home Collection Kit
Saliva collection is performed at home using the SalivaDirect Unsupervised Collection Kit

Reagents and Instruments

The SalivaDirect protocol has been validated for a wide range of reagents and instruments:

Reagents

Reagent	Vendor	Item	Catalog Number(s)
Proteinase K	ThermoFisher Scientific	MagMAX Viral/Pathogen Proteinase K	A42363
	New England Biolabs	Proteinase K	P8107S
	AmericanBio	Proteinase K	AB00925
RT-qPCR Kit	New England Biolabs	Luna Universal Probe One-Step RT qPCR (2x) Kit	E3006S, E3006L, E3006X, E3006E



		Luna Probe One-Step RT-qPCR 4x Mix with UDG	M3019S, M3019L, M3019X, M3019E



	Bio-Rad	Reliance One-Step Multiplex RT-qPCR Supermix	12010176, 12010220, 12010221


	Quantabio	UltraPlex 1-Step ToughMix	95166-100, 95166-500, 95166-01K


	ThermoFisher Scientific	TaqPath 1-Step RT-qPCR Master Mix, GC	A15299, A15300

Primer/Probes	Eurofins Genomics	SalivaDirect™ primer and probe set	12YS-010YST (Cy5), 12YS-010YS3 (HEX), 12YS-010YS2 (FAM)
	Lighthouse Lab Services	SalivaNow SARS-CoV-2 Assay (primers/probes pre-mixed)	9731816-S
	Integrated DNA Technologies	nCOV_N1 Forward Primer	10006821, 10006830

		nCOV_N1 Reverse Primer	10006822, 10006831

		nCOV_N1 Probe	10006823, 10006832

		RNase P Forward Primer	10006827, 10006836

		RNase P Reverse Primer	10006828, 10006837

		RNase P Probe	Custom order (Cy5) 10007061, 10007062 (ATTO647)



Nuclease-free water	Integrated DNA Technologies	Nuclease-free water	11-04-02-01, 11-05-01-14, 11-05-01-04
	New England Biolabs	Nuclease-free water	B1500S, B1500L
Controls	Twist Bioscience	Synthetic SARS-CoV-2 RNA Control 2	102024
	Lighthouse Lab Services	Positive CoV-2 Control	9731816PC
		Negative Control	9731816EC

For a more comprehensive list of all reagents and instruments, review the full EUA, available at FDA.gov.

Instruments

Vendor	Model(s)
Bio-Rad	CFX96 Touch, CFX384 Touch, CFX Opus Real-Time PCR Detection System
ThermoFisher	ABI StepOne/StepOne Plus ABI 7500 Fast/Fast Dx, ABI PRISM 7000, ABI ViiA 7, ABI QuantStudio 3, QuantStudio 5, QuantStudio 6, QuantStudio 7 Pro/Flex, QuantStudio 12K Flex, QuantStudio Dx Real-Time PCR System
Agilent	AriaMX Real-Time PCR System
Ubiquitome	Liberty 16, Liberty 16 Pro
Analytik Jena	qTower
Roche	Cobas Z480, LightCycler 480
CHAI	Open qPCR
Bio Molecular Systems	Mic, Mic qPCR/Q
OnsiteGene	XDiveTM Superfast Real-Time PCR System

For a more comprehensive list of all instruments and validated software versions, review the full EUA, available at FDA.gov.

Workflows

The SalivaDirect protocol has been validated for use in three different nucleic acid extraction-free sample preparation workflows. See image below.

SalivaDirect, Inc. is actively working toward obtaining FDA De Novo approval for the SalivaDirect SARS-CoV-2 assay. The protocol will initially include a single workflow using Proteinase K and focus on the following reagents and instruments:

Reagent	Vendor	Item	Catalog Number(s)
Proteinase K	ThermoFisher Scientific	MagMAX Viral/Pathogen Proteinase K	A42363
RT-qPCR Kit	New England Biolabs	Luna Probe One-Step RT-qPCR 4x Mix with UDG	M3019S, M3019L, M3019X, M3019E
Primer/Probes	Integrated DNA Technologies	nCOV_N1 Forward Primer	10006821, 10006830

		nCOV_N1 Reverse Primer	10006822, 10006831

		nCOV_N1 Probe	10006823, 10006832

		RNase P Forward Primer	10006827, 10006836

		RNase P Reverse Primer	10006828, 10006837

		RNase P Probe	Custom order (Cy5) 10007061, 10007062 (ATTO647)



Nuclease-free water	New England Biolabs	Nuclease-free water	B1500S, B1500L
Controls	Twist Bioscience	Synthetic SARS-CoV-2 RNA Control 2	102024

Vendor	Model(s)
Bio-Rad	CFX96 Touch Real-Time PCR Detection System
ThermoFisher	ABI QuantStudio 6 Pro Real-Time PCR System ABI QuantStudio 7 Pro Real-Time PCR System

In development: SalivaDirect+

While the SalivaDirect protocol focuses exclusively on detecting SARS-CoV-2, SalivaDirect+ is in development. Utilizing the SalivaDirect extraction-free protocol, SalivaDirect+ will be able to detect SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in a single saliva sample. By combining the detection of multiple viruses, SalivaDirect+ will provide a more comprehensive tool for diagnosing and differentiating between various respiratory infections – ensuring providers and patients are empowered with comprehensive health information, reducing the use of inappropriate antibiotic treatment, and improving infectious disease surveillance data for public health agencies.

SalivaDirect, Inc. is currently conducting a prospective clinical validation study to obtain emergency use authorization for the SalivaDirect+. If you or your laboratory are interested in joining the study and supporting our assay development work, contact us at [email protected]