This is a study designed to determine the 99th percentile upper reference limit (URL) for the Quidel
TriageTrue® hs-Tnl Test (TriageTrue) in whole blood and plasma.
The study will enroll apparently healthy adults. Potential subjects will be pre-screened for
eligibility using a questionnaire to assess comorbidities, chronic conditions, and medication use.
Those with comorbidities or chronic conditions that potentially affect the heart will not be eligible,
nor will those who are prescribed medications related to cardiovascular disease or risk factors.
The purpose of this research study is to see the impact of a study video on CRC screening rates and adherence.
Approximately 5,280 subjects will participate in this study at roughly 40 sites.
1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness
1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness
Researchers want to find out more about how to manage and treat suspected infections and sepsis. Sepsis is a life-threatening condition in which your body is fighting a severe infection.
This study is a collection of health information, blood samples and possibly a nose swab. The samples collected will depend on your doctor's recommendation.
The study is an experimental laboratory test (Interleukin-6, abbreviated IL-6) for infection in your blood, called IL-6 Neonates_US. An IL-6 test is a laboratory test that has not been approved by the regulatory authorities, such as the U.S. Food and Drug Administration (FDA) in your country. The results from experimental laboratory test used in this study will not be used to make a diagnosis or guide therapy.
The name of the study is PERFORM-TSIX. An investigational diagnostic test is a new diagnostic test, in this case a blood test.
The name of the study is PERFORM-TSIX. An investigational diagnostic test is a new diagnostic test, in this case a blood test.
Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.
Troponin I (cTnI) is a protein that is found in the heart muscle. When someone has a heart attack or other injury to the heart muscle, increased levels of cTnI can be measured in the blood and testing for cTnI in blood is used to help diagnose a heart attack and other heart conditions.