Consent Form: DTPM COVID-19 RT-PCR Test
INTRODUCTION:Coronaviruses (“COV”) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (“MERS-COV”) and Severe Acute Respiratory Syndrome (“SARS-COV”). The novel coronavirus (“SARS-COV-2” or “COVID-19”) is a new strain that has not been previously identified in humans.
Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur
INTENDED USE:To detect and/or diagnose COVID-19, Global 7 Diagnostics utilizes the DTPM COVID-19 RT-PCR Test (the “Test”). The Test has been authorized under the Food and Drug Administration’s (“FDA”) Emergency Use Authorization (“EUA”). The Test has not been FDA cleared or approved. The 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, as determined by the Secretary of the Department of Health and Human Services under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the EUA is terminated or revoked sooner. The Test is limited to United States laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), 42 U.S.C. §263a, to perform moderate complexity tests, and in United States laboratories certified under CLIA to perform high complexity tests, by clinical laboratory personnel who have received specific training on the use of the Test. As with any complex clinical laboratory test, there is a nominal possibility of failure or error in analysis. Extensive measures are taken to avoid these errors.
Positive results are indicative of the presence of SARS-COV-2 nucleic acid; clinical correlation with patient history and other diagnostic information are necessary to determine patient infection status. A patient obtaining a positive result should seek physician consultation immediately. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-COV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
By engaging our services, you acknowledge and agree to assume the risk of these limitations.
I understand the above statements. I had the opportunity to ask questions and have had them answered.
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TERM OF USE
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