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Thomas H. Müller, Harald Mohr, Thomas Montag
Methods for the detection of bacterial contamination in blood products Screeningverfahren zum Nachweis bakterieller Kontaminationen in Blutprodukten
Keywords: Bacteria, blood components, detection of bacteria, platelet concentrate, screening methods
Culture-based and molecular assays have been developed for the screening of platelet concentrates and other blood components for bacterial contamination. The principles of the assays are outlined.
This review focuses on the assessment of the analytical qualities of the methods. Spiking studies by adding defined levels of a wide range of bacteria to the complex biological matrix provide the first basis to evaluate and compare the qualities of methods for bacterial detection. The sensitivity acceptable for a reliable screening for bacteria critically depends on the timing of either early sampling (within a period of up to 24 h after preparation of the blood component) or late sampling (a few hours before issuing the blood component). Large screening studies are essential to confirm both adequate sensitivity and specificity of the testing. In the ideal setting, these studies are prospectively planned and include the systematic surveillance of adverse events in response to the administration of the screened products. The findings from sterility testing (predominantly with automated systems for the detection of bacteria based on CO2 generation) of more than 550,000 platelet concentrates in 13 studies are summarized. The limitations of the early sampling and the “negative-to-date” strategy with regard to issuing platelet concentrates are addressed. A few reported cases of probable bacterial transmission by platelet transfusion despite negative screening tests emphasize the need for further development of optimized methods for the testing of blood components for bacterial contamination.
LaboratoriumsMedizin, Walter de Gruyter
Print ISSN: 0025-8466
Volume: 30, 05/2006
Pages: 74 - 90