Description: COVID-19 At-Home Saliva Collection Test Kit with Prepaid Express Return Shipping for PCR Laboratory Testing

• FDA-authorized home test for SARS-CoV-2 virus detection on symptomatic and asymptomatic individuals.
• Easy and convenient at-home saliva sample with results within 1-2 days upon receipt at the laboratory
• Physician authorization is included with online registration and valid in contiguous United States.
• A fact sheet for patients and the official lab report is available online or may be downloaded.

Collection Method/Analysis Location: At-Home Collection

Sample: Saliva

Diagnostic Target: NAAT (Nucleic Acid Amplification Test) via PCR

Time to Results: Results within 24-48 hours upon receipt at the laboratory

What's in each box:

• DxTerity online registration instructions with physician prescription
• Saliva collection device
• Biohazard specimen bag with absorbent material
• Prepaid and prelabeled express return shipping box for shipping the samples on the same day of collection for next day delivery to the laboratory

Additional Resources:

EUA Summary
Healthcare Professional Fact Sheet
Patient Fact Sheet
Instructions for Use
Privacy Policy

Per the CDC: For the best results, collect and handle the sample according to the manufacturer’s instructions. If you don't collect the sample as directed, your test results may be incorrect. For example, the DxTerity sample should only be taken after a 30 minute period of nothing to eat or drink. Also, do not register the kit until you are ready to take a sample.

Refund policy: the kit is not returnable once purchased and must be used within 60 days of purchase, refunds will be provided if the physician prescription is not authorized for any reason (such as for having emergency warning symptoms at sample registration) or if results are not provided due to fault of the shipment or testing process.

DxTerity Diagnostics is a Los Angeles based CLIA licensed and CAP/ISO accredited clinical laboratory leveraging the power of genomic testing with safe and convenient from-home sample collection capabilities.

DxTerity’s COVID-19 testing program has clinically validated and is EUA authorized by the FDA. This test was developed, its performance characteristics determined, and testing performed by DxTerity Diagnostics Inc. located at 19500 S. Rancho Way, Suite 116, Rancho Dominguez, CA 90220, regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42U.S.C. as qualified to perform high complexity clinical testing. This test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by by DxTerity Diagnostics,Inc. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Results of the test should not be used as the sole basis for patient management decisions. You cannot use this test if you are experiencing any of the following emergency warning signs for COVID-19: Trouble breathing, Persistent pain of pressure in the chest, New confusion, Inability to wake up or stay awake, Bluish lips or face – It is recommended that you immediately seek emergency care. Do not eat or drink for 30 minutes prior to collection. Samples must be registered into the portal at my.dxterity.com and returned to a FedEx collection location on the same day as collection, before the last express pick-up. Samples may not be collected on Saturday or Sunday in most locations. Please see my.dxterity.com for complete terms of service and privacy policy.