- INCLUSION CRITERIA:
- Normal, healthy adult donors as judged by screening questionnaire
- Nonpregnant
- Weighing at least 110 lbs
- 18-65 years of age
- HIV negative (proof required every 6 months we will conduct test)\*
- Hepatitis B surface antigen and hepatitis C serology negative (checked every 6 months we will conduct test)\*
- The rationale for HIV and hepatitis viral testing is that chronic viral infection may alter and possibly invalidate our experimental results. HIV and hepatitis results will be confidentially obtained. Testing will be contracted to an external certified laboratory and will be paid for by the study group. Results will be available only to the study doctor/PI (Fessler), the study coordinator, the CRU Director (Garantziotis, LAI), and the donor, with the few caveats that follow
All positive HIV, hepatitis B, and hepatitis C results will be promptly communicated to the donor by the study doctor/PI or the CRU Director. The participant will be referred to their physician and/or to the N.C. Department of Health for confirmatory testing and counseling. As explained in detail in the attached Supplement describing N.C. State Department of Health code will be followed. The state code mandates reporting of positive results along with the participant s name and identifying information to the N.C. Department of Public Health. Upon contracting with the testing laboratory, clarification will be obtained and documented as to whether the contracted laboratory or the study MD will be responsible for reporting positive results to the state to avoid duplication of reporting. Upon receipt of the test results, the N.C. Department of Health will contact the participant to inform them of the positive result, how to find care, how to avoid infecting others, how the newly diagnosed HIV and/or hepatitis infection is reported, and the importance of informing their partners at possible risk because of their HIV and/or hepatitis infection. If the HIV, hepatitis B, and hepatitis C results are negative, the participant will be not be notified. However, the participant may contact the research study nurse for their results.
HIV and hepatitis B/C test results, non-reactive and reactive, will be documented confidentially by the PI or study coordinator in the subject s file, and kept in a locked file cabinet in the CRU Medical Records Room.In order to document the reporting procedure and the time associated with the reporting process, a document has been created and placed in the study specific manual (Hepatitis B/C and HIV Notification Process for Reactive Results Form)
EXCLUSION CRITERIA:
By questionnaire:
Feeling ill within the last 24 hours.
Alcohol consumption in the last 24 hours.
Visit to the dentist in the last 24 hours.
A doctor visit for illness or vaccination in the last 2 weeks.
Diarrhea in the last 2 weeks.
Recurrent fever (4 weeks).
Pregnant or suspected pregnancy in the last 6 weeks.
Blood or plasma donation that will cause the participant to exceed 550ml of blood in the last 8 weeks.
Receiving a blood donation in the past 12 months.
Bleeding disorder.
Anemia.
Heart problems.
Insulin dependent diabetes.
Problems with blood donation.
Risk of or evidence of Creutzfeldt-Jacob Disease in the family.
HIV-positive status, Hepatitis B/C-positive status or other confirmed or suspected immunosuppressive or immunodeficient conditions.
Use of immunosuppressants or other immune-modifying drugs.
Use of selected medications within the preceding 5 days unless the PI or AI receiving the samples states otherwise (NSAIDS/aspirin/tylenol, antidepressants, antihistamines , corticosteroids, HMG CoA reductase inhibitors, and antihypertensives).
By exam:
Temperature over 99.5 F.
Blood pressure less than 90/50.
Blood pressure higher than 170/95 mm Hg.
Pulse rate less than 50 or greater than 100 beats/minute.
If blood donation exceeds 200ml:
- Hematocrit less than 34% for women or less than 36% for men, or greater than 56% for either gender.
- Patients will be informed of disqualifying vital signs and hematocrit values and advised by trained staff, as appropriate, to seek assistance from their physician.