(10-PACK) DxTerity SARS-CoV-2 RT PCR CE Test - COVID-19 At-Home Collection Kit

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. This test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by DxTerity Diagnostics, Inc. This test has been authorized only for the qualitative detection of nucleic acid from SARS-CoV-2 virus that causes COVID-19, 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Results of the test should not be used as the sole basis for patient management decisions. A positive test result indicates that SARS-CoV-2 virus was detected. A negative test result does not exclude SARS-CoV-2 infection. An indeterminate test result indicates that viral detection could not be reliably determined for the specimen and that additional specimen collection for testing is recommended.

FDA AUTHORIZED HOME TEST FOR SARS-CoV-2 VIRUS DETECTION ON SYMPTOMATIC AND ASYMPTOMATIC INDIVIDUALS – This non-invasive easy to use at-home saliva test for COVID-19 has been FDA authorized for use by both individuals with and without symptoms of COVID-19. The test detects the presence of viral genetic material but will not confirm immunity or detect antibodies. This test is authorized by FDA for emergency use during the COVID emergency. SAFE, CONVENIENT, AT- HOME SAMPLE COLLECTION – Kit includes everything needed for sample collection. Only a small amount of saliva sample is needed. Avoid the discomfort of nasal swab and long lines for testing. Registration and sample collection can be done from the comfort of your home or office. Do not collect samples on Saturday or Sunday. Sample collection is unsupervised, so the report may not be valid for all travel purposes. ONLINE REGISTRATION AND AUTHORIZATION – Online registration and physician authorization process included with the kit. Samples must be registered into the DxTerity portal 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. EASY TO UNDERSTAND RESULTS – Fact sheet for patients and the official lab report will be available to you online and may be downloaded to serve as proof of your result. DxTerity developed the test and each sample is processed in our CLIA-Certified (Clinical Laboratory Improvement Amendments) and CAP Accredited (College of American Pathologists) laboratory