Current status of rapid bacterial detection methods for platelet components: A 20-year review by the ISBT Transfusion-Transmitted Infectious Diseases Working Party Subgroup on Bacteria.

Abstract

Bacterial contamination of platelet components (PCs) poses a safety challenge for transfusion patients. Despite mitigation interventions, the residual risk of transfusion-transmitted bacterial infections remains predominant. PC safety can be improved either by pathogen reduction or by implementation of bacterial detection methods. Detection methodologies include culture methods and rapid detection methods. The current review focuses on currently available rapid detection methods. We reviewed published manuscripts since 2000 on rapid bacterial detection methods used for PC screening with result determination within 4 h. Methods meeting this criterion included Verax PGDprime, BacTx and nucleic amplification testing. The analytical and diagnostic sensitivity and specificity of these systems were assessed. The analytical sensitivity between the different detection methods ranged between 50 and 100,000 CFU/ml. The sample volume used by these testing systems varies between 0.5 and 1.0ml of PCs. A delay of at least 48 h before sampling enhances detectability. All rapid detection methods generate results in a timely manner, allowing testing to be performed before transfusion with optimal sensitivity. Rapid detection methods improve PC safety regarding bacterial contamination. The assays are optimal for rapidly growing bacteria, which are more likely to cause septic transfusion reactions in patients. Because of the reduced diagnostic sensitivity, the sample collection should be late in shelf-life and ideally just before transfusion. The major benefit of these methods is that the test result can be obtained before releasing PCs for transfusion or to be used in combination with other screening methods applied early during PC storage.