You understand and agree that by completing the survey on this website and ordering a COVID-19 Test kit you understand and agree to have Psomagen Inc. Rockville, MD laboratory personnel (for purposes of this “Terms of Services Specific to COVID-19 Testing” only) to observe the collection of your saliva sample and your survey results which will allow for processing of your sample and generation of testing results. All purchases will be reviewed by PWNHEALTH to make sure you are eligible for COVID-19 testing before submitting a test order for processing. In addition, PWNHEALTH is authorized to review your result and provide healthcare advice for the next steps, if necessary. You agree that the information you have provided on this website and any information you provide during your sample collection is truthful and complete to the best of your knowledge.
Tests for COVID-19 have been authorized by the FDA under Emergency Use Authorization (EUA) for use by authorized laboratories. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostic tests for the 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.
Psomagen is required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to keep your personal health information (“Protected Health Information”) confidential. Please see our HIPAA Policy.
The SALIVADIRECTTM Test is a real-time RT-PCR test and developed by Yale School of Public Health, Department of Epidemiology of Microbial Diseases. This test has been authorized by the FDA under an Emergency Use Authorization. The test is limited to laboratories designated by the Yale School of Public Health, Department of Epidemiology of Microbial Diseases, that includes Psomagen, Inc., located at 1330 Piccard Dr. ste103, Rockville, MD 20850, that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meet the requirements to perform high complexity tests.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner. The test should not be used as the sole factor for patient management decisions rather as an adjuvant because the test may produce a false negative or false positive data due to various types of interference such as improper sample collection, the presence of RT-PCR inhibitors, and detection of viral RNA may not mean the presence of SARS-CoV2 is the causative factor for the clinical symptoms. All results will be reported to the appropriate public health authorities. No guarantees have been made to you regarding the test or results of your COVID-19 test.
Psomagen has the right to reject your sample if the following occurs:
This test is only available to users in the United States. Please check with your health insurance company with respect to coverage.
In the event that you provide a third party with your results from a COVID-19 Test for any reason, Psomagen is not responsible for any actions such third party may or may not take as a result of you providing your test result to such third party. Please, refer to our Privacy Statement on how your information is protected.
Here at Psomagen, Inc. we take our commitment to quality seriously. Our products are and either meet or exceed cGMP standards. It is important our customers are confident that they are obtaining a high-quality product. We understand that occasionally a product may not meet your expectations. Please refer to the following guidelines.
Our Products cannot be refunded once a sample is received by our lab facility. You will receive an e-mail notification once a sample is received in the lab and when your results are ready to view on the online portal. If the lab is in Received or Completed status a refund cannot be processed.
If you receive a package that has been damaged, save the original box and all its contents and call us immediately with the invoice number or barcode information. We will make every effort to remedy the situation as soon as possible. If your package was lost/stolen, please contact us at firstname.lastname@example.org with your order details so we can investigate and file a claim.
You understand and acknowledge that Psomagen does not accept returned kits for resale. If you do not wish to test, we ask that you dispose of the kit.
By completing the survey on the website and ordering a COVID-19 Test kit, you acknowledge that you have read the Terms of Service, including this “Terms of Services Specific to COVID-19 Testing” and that you understand and agree to all of the terms in the “Terms of Service,” especially the terms in this “Terms of Services Specific to COVID-19 Testing”.
For all information about our COVID-19 tests, please contact us at email@example.com.