| Product |
No. of Studies |
No. of Positive Units |
No. of Units Tested |
Positive Units (per 105 U) |
Approximate Frequency |
| Whole Blood Derived Platelet Concentrates (a) |
8 |
64 |
188,958 |
33.9 |
1 in 3,000 |
| Apheresis Platelet Concentrates (b) |
5 |
21 |
41,175 |
51.0 |
1 in 2,000 |
| Red Blood Cells (c) |
2 |
1 |
38,475 |
2.6 |
1 in 38,000 |
| Overall |
15 |
86 |
268,608 |
32.0* |
1 in 3,00 |
|
|
References: a[5, 6, 7, 8, 9, 10, 11, 12], b[7, 8, 13, 14, 15], c[7, 14] *95% confidence intervals; 25.6 to 39.1
Impact of Bacterial Contamination
- Transfusion-associated bacterial sepsis is estimated to occur in 1 case per 6 contaminated units transfused [16], and can be fatal in up to 1 in 4 cases [17].
- In the UK, Serious Hazards of Transfusion (SHOT) data from 1996 to 2001 indicate that 60% of all reported cases of transfusion-transmitted infection were attributed to bacterial contamination [18].
- In France, Haemovigilance Network data reported 15% of transfusion-related deaths between 1996 - 1997 were due to bacterial contamination [4, 19].
Current Safeguards
Despite a battery of tests for viral pathogens, only a single bacterial strain—Treponema pallidum, the bacterium that causes syphilis—has historically been selected for routine screening.
Although automated culture methods are available for detecting the presence of different classes of bacteria, these systems have limitations, including sampling errors, false-positive and false-negative results, and long lead times of up to 48 hours for reporting.
Benefits of the INTERCEPT Blood System
The INTERCEPT Blood System offers broad-spectrum inactivation of bacterial pathogens in platelet concentrates and plasma, reducing the risk of transfusion-transmitted infection.
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