Comparison Study of the Xpert Tap Panel Test Between Trained and Untrained Users on the Genexpert Edge X System
Study on a Test for Detecting Serious Infections
Thomas E. Davis
Primary Investigator
Brief description of study
The purpose of the study is to develop a new diagnostic test that could detect if a person is infected with tularemia, anthrax, and/or plague (acronym: TAP).
Detailed description of study
Participants will have 2 blood tubes and 2 fingerstick blood samples collected. Altogether, this will be about 5 mL of blood, which is approximately 1 teaspoon of blood.
Additionally, participants' medical records will be reviewed and medical information will be gathered. This will be completed in a single visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy
-
Age: 14 years or above
-
Gender: All
Inclusion criteria
• Participant is ≥14 years of age.
• Participant is “healthy” as defined by this protocol
• Participant is able and agrees to provide either:
o paired specimens comprising of two tubes of ≥ 2mL
VWB (at least 4 mL total volume) and two CWB
specimens (≥ 500μL total volume)
or
o two CWB specimens (≥ 500μL total volume) for the study
without compromising their health or well-being.
Exclusion criteria
Healthcare professional does not feel the participant is a suitable
candidate for VWB and/or CWB collection.
• Participant has been previously enrolled into this protocol.
• The VWB specimen was not collected per the manufacturer’s
instructions.
The CWB specimen was not collected per the manufacturer’s
instructions.
This study investigates a new diagnostic test to detect infections such as tularemia, anthrax, and plague. These are serious diseases caused by bacteria, and early detection is important. The study compares the test results from trained and untrained users using a system called Genexpert Edge X.
Participants will provide blood samples, which include two blood tubes and two fingerstick samples, totaling about 5 mL of blood. Additionally, their medical records will be reviewed to gather necessary medical information. All procedures will be completed in a single visit.
- Who can participate: Participants must be 14 years or older and considered healthy. They should be able to provide the required blood samples without health risks. Enrollment is by invitation only.
- Study details: Participants will provide blood samples, including venous whole blood and capillary blood. Medical records will also be reviewed to collect information. Enrollment is by invitation only.
- Study visits: The study requires 1 visit.
