INTERCEPT Blood System for Plasma

Bacteria

Although bacterial contamination is not common for plasma, studies performed using representative gram-negative and gram-positive organisms demonstrated efficacy of the INTERCEPT process for bacterial inactivation. In addition, studies demonstrated inactivation of two spirochete bacteria, Treponema pallidum, for which blood is currently tested, and Borrelia burgdorferi. Studies were carried out with these organisms because they are known to be asymptomatically present in the blood during chronic infections. Bacteria, which have been shown to be inactivated, are listed in Table 2.

Table 2: Inactivation Claims - Bacteria

* “>” refers to inactivation below the limit of detection of the assay;
“≥” refers to inactivation at or below the limit of detection of the assay
** intracellular inoculum