The hot topic for discussion at the British Blood Transfusion Service meeting held in October 2003 was the impact that the European IVD Directive will have on blood donor screening methods
The hot topic for discussion at the British Blood Transfusion Society (BBTS) meeting held in October 2003 was the impact that the European IVD Directive will have on blood donor screening methods.
The copper sulphate test currently used throughout the UK and Ireland for primary screening at donor centres clearly fails to comply with the Directive that becomes obligatory under European Law in December 2003.
The Directive applies to reagents, reagent products, calibrators and instruments intended for the in vitro examination of human tissue, blood or fluid samples for the purpose of providing information about the patient or donor's health.
Methods must conform to specified performance in terms of analytical and diagnostic sensitivity and specificity, accuracy, repeatability, and limits of detection. All of the National Blood Authorities are aware of the implications of the IVD Directive, and the Irish BTS is understood to be leading the way in terms of conformity.
The intention is to replace the old copper sulphate test traditionally used for primary screening in favour of a laboratory quality haemoglobin measurement with effect from 1 January 2004.
Independent studies have often questioned the accuracy of the copper sulphate test and a recent paper from the Trent NBS Centre, published in Transfusion (March 2003) reported that 11.2% of females and 5.2% of males who pass the copper sulphate primary screening test have haemoglobin levels below Council of Europe guidelines for blood donation.
This equates to approximately 145,600 women being inappropriately bled each year. However, the test has remained the method of choice for the National Blood Service a situation that now looks certain to change.
Compliance with the IVD Directive should now ensure that a far more accurate primary screening procedure is introduced to improve the confidence and well being of blood donors.
