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Consent Form: Saliva LDT 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 a LDT Saliva COVID-19 RT-PCR Test (the “Test”). The Test has not been FDA cleared or approved. 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.

I am signing as *

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Step 2

Personal Details

Sample Kit ID
Registration for Individual or Family
Patient Ethnicity
I consider myself: *
Patient Race
Which of the following racial designations best describes you (select one or more): *
How did you hear about us? *
In addition to E-Mail, I want to receive my Patient QR-Code through this notification type:

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Insurance / Payment Details

Do you have insurance? *
How will you be paying? *

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Health

I have follwing condition(s): *
I have a condition that weakens my immune system or makes it harder to fight infections: *
I am taking one of these medications: *
I am or may be pregnant
I regularly use tobacco or nicotine products (e.g. cigarettes, e-cigarettes, vapes, hookah, etc.)
Have you possibly been exposed to the Coronavirus in the past 2 weeks? *
Yes, I have been in close proximity (within 6 ft.) to someone who has been diagnosed with or presumed to have COVID-19. *
Yes, I have been in close proximity (within 6 ft.) to someone who is sick but has not been diagnosed with COVID-19. *
Yes, I live, work or have visited a place where COVID-19 is widespread. *

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Symptons

Have you had any of the following symptoms since December 2019: *
Are you currently experiencing any of these symptoms? *