Terms of Service Specific to COVID-19 Testing

Updated: June 30, 2021

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.

1. Emergency Use Authorization (EUA)

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.

2. HIPAA

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.

3. Disclaimer on a COVID-19 Test Report

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.

4. Sample Rejections

Psomagen has the right to reject your sample if the following occurs:

  1. You do not ship your sample on the same day the sample was collected.
  2. The sample tube is not sealed according to instructions in the biohazard bag.
  3. The kit is not registered.
    1. All unregistered kits expire after six (6) months from the date of purchase.
    2. The sample is mailed on a Friday, Saturday, or Sunday after the last pick-up or end of business day. Do not deliver your sample to a drop box on the weekend.
    3. The sample expires before the lab is able to process it (5-7 days from collection date).
  4. Our assays targets N1 and N2 genes for COVID-19 detection. The SARS-CoV-2 variants can evade detection by some of other assays targeting S gene. So, our assay is less likely to be impacted by the variants.
  5. Inconclusive results can occur if customers are tested too soon from the time they were exposed to the virus. It can also occur if there was a problem with how the sample was collected or the test itself.
  6. Invalid results can occur if there was a problem with how the sample was collected or transported, or issues with the test itself.

This test is only available to users in the United States. Please check with your health insurance company with respect to coverage.

5. Third Party

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.

6. Return Policy

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.

  1. Cancelling an Order
    You can cancel your order within 60 minutes of placing the order via the order confirmation email.
    For order cancellation requests after 60 minutes, please refer to the Standard Refund Policy.
  2. Changing an Order
    After an order is placed, it is not possible to alter the details or contents associated with that order. If you would like to change your order, you may cancel it. Then, place a new order with your preferred products. *Once the 60-min order cancellation window has closed, please refer to the refund/return policy.
  3. Return/Refund Policy
    Refunds will only be offered for unopened kits sealed in the original packaging. Please contact Customer service at health@psomagen.com to submit refund requests. Refund requests will be handled according to the date of request and date of purchase:
    1. Refund requests submitted within 24 hours of purchase will be offered a full refund (including shipping costs and taxes).
    2. Refund requests submitted after we have already shipped out your order, within 30days of purchase will be offered a partial refund (purchase price minus $30 or $45 for expedited shipping) for unused sample collection kits.
    3. Refund requests submitted after the kit with your specimen are returned to us, within 30 days of purchase will not be processed.
    4. Any refund request submitted after 30 days of purchase will not be processed.
    5. In all cases, we cannot accept returned/unused kits. If you received your order and do not wish to continue with the test, we ask that you dispose of the kit.
    6. Refund requests submitted after 24 hours are contingent upon receipt of your collection kit(s) by Psomagen, Inc. within 30 days of your request for refund.

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.

7. Damaged/Lost Packages/Invalid Bar Code Registration

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 health@psomagen.com with your order details so we can investigate and file a claim.

8. Returned Kits

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 health@psomagen.com.