Pall Corporation (NYSE: PLL) announced the CE marking of
its eBDS System to detect bacterial contamination of red blood cells,
the most widely transfused blood component. The Pall eBDS is a highly
sensitive culture-based test routinely used by blood centers to detect
bacterial contamination of platelets, the leading infectious cause of
sickness and death from a transfusion. Results of a new study
presented at the International Society of Blood Transfusion (ISBT)
2006 Congress show the efficacy of the system in also detecting
bacteria that are commonly found as contaminants of red blood cells.
Since the availability of the Pall eBDS for detection of bacteria
in platelets, there has been interest in applying the same technology
to improve safety of red blood cells. Recent studies have documented
sepsis and death caused by transfusion of contaminated red cells, with
the bacteria Yersinia enterocolitica most often implicated. The U.S.
FDA estimates that the rate of bacteria associated adverse reactions
from Yersinia is one per 500,000 units of red cells, although they
note that this rate may be underestimated. The U.S. Centers for
Disease Control and Prevention (CDC) estimates bacterial contamination
of red blood cells at one per million units whereas other nations have
reported incidence as high as one in 65,000 units with a fatality rate
of one in 104,400 units.
Despite the unknown actual number of cases, there is no question
that transfusion of a contaminated red blood cell, especially if
contaminated with gram-negative bacteria, is a rapid and catastrophic
event with a quick onset of sepsis and greater than 60 percent
mortality rate. Multiple studies have also documented a link between
transfusion of red blood cells with nosocomial (hospital-acquired)
infection. Critically ill patients who receive red cell transfusions
are at increased risk of a nosocomial infection with a significant
increase in mortality and/or length of stay in intensive care.
"Adding bacterial detection of red cells along with platelets can
have a significant impact on the safety of the blood supply," says
Allan Ross, President, Pall Medical. "The blood centers that employ
the Pall eBDS for platelet testing can simply and readily use it to
detect bacteria in red cells. This is a highly cost-effective way to
help them ensure they can provide the safest blood for transfusion."
The Pall eBDS uses a novel approach to detection by measuring
oxygen consumption as the marker for bacteria. If bacteria are present
in the blood sample collected, an increasing amount of oxygen is
consumed through the metabolic activity and proliferation of the
bacteria during incubation, resulting in a measurable decrease in
oxygen content.
The study presented to the ISBT tested the Pall eBDS on 662 red
blood cell samples that had been inoculated separately with twelve
different bacteria strains. Each sample was tested after 48 hours
resulting in 100 percent detection of the contaminating bacteria.
Pall, the leading global provider of filtration and other technologies
to enhance the safety of the blood supply, conducted this study in
response to the need to reduce the problem of bacterial contamination
of blood components.
#1 Infectious Source of Transfusion-Transmitted Disease
There has been an astounding reduction in the risk of viral
infections from a blood transfusion, especially with routine testing
for viruses that cause diseases such as hepatitis and AIDS. As a
result of these advances, the risk of infection from bacterial
contamination of blood products exceeds that from viral agents and has
emerged as the greatest residual infectious source of
transfusion-transmitted disease.
Bacterial contamination is most often found in platelets and the
use of a sensitive culture-based detection test, such as the Pall
eBDS, is helping solve the problem. Since the introduction of Pall's
Acrodose(TM) PL System, more blood centers are moving forward in
providing whole-blood derived platelets to alleviate platelet
shortages. It allows blood centers to efficiently conduct a single
culture-based bacterial contamination test for a bacteria-free,
transfusion-ready therapeutic dose of platelets. Using the Pall eBDS,
these centers will be able to ensure that red cells derived from whole
blood collection are also free from contaminating bacteria.
As some nations urge greater use of autologous red blood cells (a
person's own pre-donated blood) for transfusion, especially for
non-emergency surgical patients, concerns about the safety of this
blood has become more paramount. It is not generally appreciated that
autologous blood may not be safe from bacteria and can become
contaminated whether it's from environmental factors, skin
contamination at the time of donation or during the handling and
processing after collection. In the U.S., one in 16,999 autologous
units has 12 times more likely risk of contamination than those
associated with community donations from healthy individuals. Japan is
one of the nations currently investigating bacteria contamination of
autologous red cells and is using the Pall eBDS as one of its study
methods. Testing autologous red blood cells for bacteria can ensure
it's safe use to help conserve and supplement the blood supply to
alleviate emerging blood inventory shortages.
About Pall
Pall Corporation is the global leader in the rapidly growing field
of filtration, separations and purification. Pall's business is
organized around two broad markets: Life Sciences and Industrial. The
Company provides leading-edge products to meet the demanding needs of
customers in biotechnology, pharmaceutical, transfusion medicine,
semiconductor, water purification, aerospace and broad industrial
markets. Total revenues for fiscal 2005 were $1.9 billion. The Company
headquarters is in East Hills, New York with extensive operations
throughout the world. Visit Pall at www.pall.com.
Editor's Notes:
-- Photos and additional information about the Pall eBDS along
with a Scientific and Technical Report on the study results
can be found on http://www.pall.com/corporate_40982.asp
-- Visit the Pall booth Stand 5, Hall 1B at the 29th Congress of
the International Society of Transfusion Medicine in the
International Conference Centre, Cape Town, South Africa from
September 2 through 7.
-- The CE mark certifies that the product meets the safety and
efficacy requirements for it to be marketed throughout the
European Union.
