INTERCEPT Blood System for Platelets
Bacteria
The INTERCEPT Blood System for platelets has been shown to inactivate a variety of bacteria in platelet components. Inactivation studies using a range of gram positive and gram negative pathogenic bacteria demonstrated inactivation of approximately 6 logs of organisms, with the exception of P. aeruginosa and B. cereus (including spores), which showed reductions of 4.5 and 3.6 logs, respectively. Bacterial spores are resistant to inactivation; however, spore-forming bacteria in the vegetative state are sensitive to inactivation.
The results of these studies are summarized below:
Table 2: Inactivation Claims - Bacteria
| Gram-Negative Bacteria |
| Escherichia coli |
>6.4
|
≥7.3
|
| Serratia marcescens |
>6.7
|
-
|
| Klebsiella pneumoniae |
>5.6
|
≥6.7
|
| Pseudomonas aeruginosa |
4.5
|
-
|
| Salmonella choleraesuis |
>6.2
|
-
|
| Yersinia enterocolitica |
>5.9
|
>7.3
|
| Enterobacter cloacae |
5.9
|
-
|
| Anaplasma phagocytophilum (HGE agent)** |
-
|
>4.2
|
| Gram-Positive Bacteria |
| Staphylococcus epidermidis |
>6.6
|
>7.4
|
| Staphylococcus aureus |
6.6
|
>7.6
|
| Streptococcus pyogenes |
>6.8
|
-
|
| Listeria monocytogenes |
>6.3
|
-
|
| Corynebacterium minutissimum |
>6.3
|
-
|
| Bacillus cereus (includes spores) |
3.6
|
-
|
| Bacillus cereus (vegetative) |
>6.0
|
-
|
| Bifidobacterium adolescentis |
>6.5
|
-
|
| Propionibacterium acnes |
>6.7
|
-
|
| Lactobacillus species |
>6.9
|
-
|
| Clostridium perfringens (vegetative form) |
>7.0
|
-
|
| Spirochete Bacteria |
| Treponema pallidum (syphilis) |
≥6.8 to ≤7.0
|
>5.9
|
| Borrelia burgdorferi (Lyme disease) |
>6.8
|
>10.6
|
* “>” refers to inactivation below the limit of detection of the assay
** intracellular
“-” means not tested
 Platelet Technical Data Sheet Page 4 of 7
|
