Bonfils Prepares to Launch New HIV Test

Bonfils is pleased to announce that we will begin testing for HIV type O in March 2007 (HIV+O).  This is another step towards making the blood supply even safer for recipients.  Currently, Bonfils screens for HIV type O through two travel questions on the donor questionnaire and although our screening process is effective, nothing is as effective in detecting diseases as a blood test.

Not only will this new test reduce the number of questions on our donor questionnaire, it will increase the donor pool by allowing us to accept donors who have been deferred in the past for being born in or residing in one of the following African countries:  Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger or Nigeria. Currently, until the HIV+O test is implemented, Bonfils conducts additional face-to-face screening with donors who have traveled to one of these risk countries. If the screening indicates a donor lived in a risk area or received medical treatment, then Bonfils must defer that donor. Per FDA guidelines Bonfils is also required to defer any donor who has ever had sexual contact with anyone who was born in or lived in one of the risk countries.

Currently the FDA has no guideline for donor re-entry for a blood center that is tests for HIV type O. We are in the process of creating a re-entry protocol proposal that will allow Bonfils to have a re-entry program for our donors that have false positives with HIV tests.  The proposal was submitted at the end of 2006 and Bonfils hopes to garner FDA approval by March 2007.  If your hospital-based blood center is interested in learning more about our re-entry program proposal for consideration at your healthcare facility or if you would like to submit your own proposal to the FDA, please contact Gina Ramirez, Bonfils' manager of regulatory affairs at 303.363.2221.

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