Methods for the detection of bacterial contamination in blood products
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Thomas H. Müller
, Harald Mohr and Thomas Montag
Abstract
Culture-based and molecular assays have been developed for the screening of platelet concentrates and other blood components for bacterial contaminations. In this review, the principles of the assays are outlined.
The focus of this review is 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 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 systematic surveillance of adverse events in response to the administration of the screened products. The findings from sterility testing (predominantly with automated systems for detection of bacteria based on CO2 generation) of more than 550,000 platelet concentrates in 13 studies are summarised. The limitations of the early sampling and the “negative-to-date” strategy to issue platelet concentrates are addressed. A few reported cases of probable transmission of bacteria by platelet transfusion despite negative screening tests emphasise the need to further develop optimised methods for testing of bacteria blood components.
Clin Chem Lab Med 2008;46:933–46.
©2008 by Walter de Gruyter Berlin New York
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- Validation criteria for nucleic acid amplification techniques for bacterial infections
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Articles in the same Issue
- Editorial
- CCLM: Evolving to meet the needs of today's laboratory professionals and scientists
- Bacterial detection and blood product contamination
- Editorial: Rapid diagnostic tests to detect pathogenic microorganisms
- Reviews
- Rapid methods for diagnosis of bloodstream infections
- Validation criteria for nucleic acid amplification techniques for bacterial infections
- Incidence of bacterial transmission and transfusion reactions by blood components
- Strategies of bacteria screening in cellular blood components
- Methods for the detection of bacterial contamination in blood products
- Bacteria detection by flow cytometry
- Rapid screening by real-time 16S rDNA PCR for bacterial contamination of blood products
- Microbial safety of cell based medicinal products – what can we learn from cellular blood components?
- Genetics and Molecular Diagnostics
- Screening for genetic heterogeneity in the interferon sensitivity determining region of the hepatitis C virus genome by polymerase chain reaction with melting curve analysis
- Thiopurine S-methyltransferase (TPMT) pharmacogenetics: three new mutations and haplotype analysis in the Estonian population
- Genetic testing for adult-type hypolactasia in Italian families
- Improved real-time detection of the H63D and S65C mutations associated with hereditary hemochromatosis using a SimpleProbe assay format
- Easy detection of 5,10-methylenetetrahydrofolate reductase 1298A/C genotype by mutagenically separated PCR assay
- General Clinical Chemistry and Laboratory Medicine
- Mediterranean diet and plasma concentration of inflammatory markers in old and very old subjects in the ZINCAGE population study
- Plasma interleukin-1β, -6, -8 and tumor necrosis factor-α as highly informative markers of pelvic inflammatory disease
- The effect of hypothyroidism, hyperthyroidism, and their treatment on parameters of oxidative stress and antioxidant status
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- Letters to the Editor
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- Erratum
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