The Serious Hazards of Transfusion scheme (SHOT) in the
UK between 1996 and 2004 analysed 2630 reports of
adverse reactions and events associated with transfusion
of labile blood components [1]. Among the 1832 events
classified as incorrect blood component transfused (IBCT),
249 ABO-incompatible transfusions were reported.
During this 8-year period, taking into account the 27
million blood components issued by the UK blood services,
the risk of IBCT can be estimated at 1:15 000 blood components issued, an ABO-incompatible transfusion at
1:100 000 and the risk of death as a result of an IBCT at
1:1 500 000 [1]. In 2012, almost 10 years after, the
annual SHOT report revealed that there were 10 ABOincompatible
red cell transfusions corresponding to a risk
of 1:214 678 red cells issued, all resulting from clinical
errors with 4 inducing major morbidity from haemolysis
[2].
In 2008, the Food and Drug Administration (FDA)
reported that 7% of transfusion-related deaths were
attributable to ABO-associated haemolytic reactions [3].
Linden et al. [4] observed that one error-related ABOincompatible
transfusion occurred every 38 000 RBC
units transfused in New York State.
The Haemovigilance network in France showed similar
findings from 1994 to 1998 and estimated the risk of death due to ABO-mismatched transfusion at 1:1 800 000
allogeneic red cell units transfused [5].
Since 1985, the French authorities have introduced a
systematic bedside ABO agglutination test for checking
that the right blood is given to the right patient. Consequently,
the incidence of ABO-incompatible transfusions
has decreased to 1:235 000 [6]. Their experience underlines
the efficiency of bedside verification of ABO group
on both patient and donated blood. However, this strategy
requires an extremely time-consuming learning programme
and still relies on a human interpretation of bedside
card ABO agglutination test.
To our knowledge, there is currently no automated
bedside agglutination assay allowing an easier verification
of ABO group just before transfusion. We therefore
decided to evaluate the feasibility of a device able to perform
an agglutination test that could be fully automatizable
to be used at the bedside. It should be associated
with a patient identification system using barcoded wristbands.
This point-of-care testing (POCT) will deliver the
result of the ABO compatibility between the patient and
the blood bag without any human intervention either to
perform the test or to interpret the results. The objective
of this work is the proof of concept of a simple device for
bedside blood group determination. This should lead to
the development of a fully automated device based on
the same principle that will be fully validated in clinical
settings.
The Serious Hazards of Transfusion scheme (SHOT) in theUK between 1996 and 2004 analysed 2630 reports ofadverse reactions and events associated with transfusionof labile blood components [1]. Among the 1832 eventsclassified as incorrect blood component transfused (IBCT),249 ABO-incompatible transfusions were reported.During this 8-year period, taking into account the 27million blood components issued by the UK blood services,the risk of IBCT can be estimated at 1:15 000 blood components issued, an ABO-incompatible transfusion at1:100 000 and the risk of death as a result of an IBCT at1:1 500 000 [1]. In 2012, almost 10 years after, theannual SHOT report revealed that there were 10 ABOincompatiblered cell transfusions corresponding to a riskof 1:214 678 red cells issued, all resulting from clinicalerrors with 4 inducing major morbidity from haemolysis[2].In 2008, the Food and Drug Administration (FDA)reported that 7% of transfusion-related deaths wereattributable to ABO-associated haemolytic reactions [3].Linden et al. [4] observed that one error-related ABOincompatibletransfusion occurred every 38 000 RBCunits transfused in New York State.The Haemovigilance network in France showed similarfindings from 1994 to 1998 and estimated the risk of death due to ABO-mismatched transfusion at 1:1 800 000allogeneic red cell units transfused [5].Since 1985, the French authorities have introduced asystematic bedside ABO agglutination test for checkingthat the right blood is given to the right patient. Consequently,the incidence of ABO-incompatible transfusionshas decreased to 1:235 000 [6]. Their experience underlinesthe efficiency of bedside verification of ABO groupon both patient and donated blood. However, this strategyrequires an extremely time-consuming learning programmeand still relies on a human interpretation of bedsidecard ABO agglutination test.To our knowledge, there is currently no automatedbedside agglutination assay allowing an easier verificationof ABO group just before transfusion. We thereforedecided to evaluate the feasibility of a device able to performan agglutination test that could be fully automatizableto be used at the bedside. It should be associatedwith a patient identification system using barcoded wristbands.This point-of-care testing (POCT) will deliver theresult of the ABO compatibility between the patient andthe blood bag without any human intervention either toperform the test or to interpret the results. The objectiveof this work is the proof of concept of a simple device forbedside blood group determination. This should lead tothe development of a fully automated device based onthe same principle that will be fully validated in clinicalsettings.
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