HSA’s advisory on the use of the ID-Micro Typing System test cell reagent ID-DiaCell I-II-III

HSA would like to update healthcare professionals on the reports it has received relating to the ID-Micro Typing System test cell reagent, ID-DiaCell I-II-III. The ID-Micro Typing System test cell reagent, ID-DiaCell I-II-III, is licensed in Singapore by Bio-Rad Laboratories (Singapore) Pte Ltd for the detection of antibodies that may be present against the antigens on red blood cells during compatibility testing for blood transfusion.

Background

The ID-Micro Typing System test cell reagent ID-Diacell I-II-III consists of human red blood cells from single donors intended for use in antibody screening with the Indirect Antiglobulin Test (IAT) and the NaCl test. Recently,Bio-Rad received reports of an unexpectedly high number of false positive reactions with the use of test cell reagent (cell III) of the ID-Micro Typing System test cell reagent ID-Diacell I-II-III.Bio-Rad has initiated investigations into the possible reasons that may have resulted in these false positive reactions. However, the preliminary tests on the corresponding reference material, using the Bio-Rad ID system, at Bio-Rad manufacturing site have not yet identified the root cause of this problem.

HSA's advisory

HSA had issued a Dear Healthcare Professional Letter in August 2011 to alert healthcare professionals to the potential risks of possible false positive reactions that may occur with the use of the ID-Micro Typing System test cell reagent ID-Diacell I-II-III. Healthcare professionals who require the ID-Micro Typing System test cell reagent ID-Diacell I-II-III are advised to take into consideration the high rate of false positives when using this reagent for diagnostic purposes. It is recommended that all samples tested positive in the antibody screen should be confirmed by an antibody identification test.