Inactivation Data
Proven Efficacy Against over 40 Clinically Relevant Pathogens1The INTERCEPT® Blood System for Platelets, pathogen reduction system, provides robust, broad-spectrum reduction,
reducing the risks of transfusion-transmitted infection (TTI), including sepsis, and is approved as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD).
What is log reduction?
In terms of 1 log, reduction means a 10 fold reduction in the number of live bacteria.
A log reduction of at least 4 is required by the FDA to consider that a given pathogen has been inactivated.
For example:
1 log reduction would be reducing the amount of bacteria by 90%
2 log reduction would be reducing the amount of bacteria by 99.0%
4 log reduction would be reducing the amount of bacteria by 99.99%
5 log reduction would be reducing the amount of bacteria by 99.999%
Bacteria
(Gram-negative and Gram-positive)
| Log Reduction1 (cfu/mL)a | ||
| Platelets in 65% PAS-3/ 35% plasma |
Platelets in 100% Plasma |
|
| Klebsiella pneumoniae | >6.2 | >6.2 |
| Escherichia coli | ≥6.3 | >5.9 |
| Serratia marcescens | ≥6.7c | >7.1 |
| Pseudomonas aeruginosa | ≥6.7 | ≥6.7 |
| Salmonella choleriaesuis | 6.2 | >5.9 |
| Enterobacter cloacae | >6.6 | >6.8 |
| Yersenia enterocolitica | ≥5.9 | >6.3 |
| Staphylococcus epidermidis | ≥6.4 | >6.5 |
| Staphylococcus aureus | ≥6.6 | ≥6.5 |
| Listeria monocytogenes | ≥6.3c | >6.6 |
| Corynebacterium minutissimum | ≥5.3 | >6.4 |
| Streptococcus pyogenes | ≥6.8c | >6.1 |
| Bacillus cereus (vegetative) | ≥5.5 | ≥5.6 |
| Bacillus cereus (spore forming) | 3.7c | b |
| Bifidobacterium adolescentis | ≥6.0 | b |
| Clostridium perfringens (vegetative) | ≥6.5 | >6.0 |
| Propionibacterium acnes | ≥6.5 | >6.7 |
| Treponema pallidum (Syphilis) | ≥6.4 | >6.3 |
| Borrelia burgdorferi (Lyme disease) | ≥6.8 | >4.1 |
Virus
(enveloped and non-enveloped)
| Log Reduction1 (pfu/mL)a | ||
| Platelets in 65% PAS-3/ 35% plasma |
Platelets in 100% Plasma |
|
| HIV-1 IIIB, cell-associated | ≥5.4 | ≥4.7 |
| HIV-1 IIIB, cell-free | ≥5.6 | b |
| HIV-1 Z84 (clinical isolate) | ≥3.3 | b |
| HIV-2 CLB-20 (clinical isolate) | ≥2.4 | b |
| DHBV (model virus for HBV) | ≥4.8 | ≥4.3 |
| BVDV (model virus for HCV) | ≥4.1 | >3.5 |
| HTLV-I | 4.7 | b |
| HTLV-II | ≥5.1 | b |
| West Nile virus (WNV) | ≥6.3 | >6.3 |
| Chikungunya virus (CHIKV) | ≥5.7 | >6.5 |
| Dengue virus (DENV) | ≥4.3 | 3.6 |
| Cytomegalovirus (CMV) | ≥4.9 | b |
| Pseudorabies Virus (model for CMV) | b | ≥4.2 |
| Influenza A virus | ≥5.9 | b |
| Calcivirus (model non-enveloped virus) | 2.1 | 0.9 |
| Adenovirus | ≥4.9 | ≥5.3 |
| Bluetongue virus (model non-enveloped virus) | 5.2 | 4.4 |
Protozoan
Parasite
| Log Reduction1 (pfu or cfu/mL)a | ||
| Platelets in 65% PAS-3/ 35% plasma |
Platelets in 100% Plasma |
|
| Plasmodium falciparum | ≥6.6 | >6.5 |
| Babesia microti | ≥4.9 | >4.5 |
| Trypanosoma cruzi | ≥7.8 | >8.4 |
| Leishmania mexicana (metacyclic promastigote stage) |
≥5.0 | b |
Leukocyte
For a full list of pathogens, see Package Insert. a. Based on input titer and post-treatment titer in 1 mL, data obtained in platelet components in PAS-3 or plasma components unless otherwise noted. b. Not tested. c. Based on culture of full platelet unit (300mL).
1. INTERCEPT Blood System for Platelets [Package Insert]. Concord, CA: Cerus Corporation.