Covid-19 Test

Terms of Service

global 7 COvid-19 

terms of service

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 which has not previously been 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: 

 

The SARS-COV-2 or COVID-19 Test (“Test”) utilized by Global 7 Diagnostics is for informational use only and should not be used for diagnostic purposes.  The Test has been validated but the Food and Drug Administration’s (“FDA”) independent review of the validation is pending. The Test is performed as a laboratory developed test; independent review of the validation under the FDA's Emergency Use Authorization (“EUA”) authority will be performed according to current guidance requirements.  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 antibodies; 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. Global 7 Diagnostics is required to report all positive results to the appropriate public health authorities.

 

By engaging our services, you acknowledge and agree to assume the risk of these limitations.