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 authorized laboratories. This test has been authorized only for the detection and differentiation of nucleic acid of SARS-COV-2 from multiple viral and bacterial organisms. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use on in vitro diagnostics test for detection and diagnosis of COVID-19 infection under section 565(b) (1) of the Act, 21 U.S.C. 360bbb-3 (b) (1), unless the authorization is terminated or revoked sooner. When diagnostic testing is negative (not detected), the possibility of false negative results should be considered in the context of a patient's recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. An individual without symptoms of COVID-19 and who is not shedding SARS-COV-2 virus would expect to have a negative (not detected) result in this assay.
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 authorized laboratories. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use on in vitro diagnostics test for detection and diagnosis of COVID-19 infection under section 565(b) (1) of the Act, 21 U.S.C. 360bbb-3 (b) (1), unless the authorization is terminated or revoked sooner. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2 , not for any other viruses or pathogens. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
CONSENT AND AUTHORIZATION
I am ordering the laboratory tests indicated below. By providing my email address below, I am authorizing Quick Test Lab Diagnostics or their affiliates to email me my test
results to the address indicated, even though I understand there is a risk the email may not be secure and could be read by a third party.
DISCLAIMER: The specimen collection tube contains reagents/liquids that could be hazardous with direct contact to skin, eyes, mucus membranes or if ingested. DO
NOT drink the fluid within the specimen tube. DO NOT breathe vapors. DO NOT use bleach for cleaning or disinfection. DO NOT place the swab into the fluid prior to collection
of the specimen. The specimen collection tube contains Guanidine Thiocyanate which forms very toxic gases on contact with acids. Keep away from acidic or alkaline products
and oxidizing agents.
I am requesting Direct Access Testing. I do not have a physician order for these tests. I understand that only I and the entity paying for this testing will receive the testing results. We the Laboratory may share the test results with my physician or other providers only in critical or emergent situations or as required by law.
I understand that certain patient test results are required by law to be reported to the federal, state and local health department for public health reasons. I understand it is my responsibility to consult with my doctor and/or contact my county health department main office.
I am 18 or older. If <18, I am an emancipated minor or otherwise authorized to request and provide consent for the tests ordered below. If I am requesting testing for which a minor is required by law to consent the minor has consented to such testing.
I understand that both federal and state law prohibits laboratories from billing health insurance for patient ordered laboratory testing. I further understand that these tests are not covered by Medicare as Medicare does not cover laboratory testing without a physician order.
I understand that it is solely my responsibility to promptly discuss all laboratory results with a physician and that neither the laboratories nor its Medical Director will provide interpretation, counseling, consultation, or care recommendations on the basis of any laboratory results provided to me. I release from liability and will not hold the laboratories or their directors responsible if I do not promptly communicate the results of these tests to my physician.