Evaluation of an improved rapid bacterial assay with untreated and pathogen‐reduced platelets: Detection of Acinetobacter strains

Abstract

Background: The PGDprime ® test was updated to enable Acinetobacter spp. detection to respond to morbidity and mortality events in 2018 and 2020 involving platelets contaminated with Acinetobacter-calcoaceticus-baumannii complex (ACBC). In one morbidity event, the first-generation PGD test failed to detect ACBC. In two other reported events, pathogen-reduced (PR) platelets contaminated with ACBC and other bacteria led to patient morbidity and one death. Study Design and Methods: A polyclonal antibody to Acinetobacter was integrated in the test device and evaluated for detection of Acinetobacter spp., including the ACBC isolate recovered in one of the 2018 contamination events. Limits of Detection for various Acinetobacter strains were determined in dilution studies. Detection of Acinetobacter growing in platelets after an initial low inoculum was evaluated. Use of the updated test as a secondary test after pathogen reduction was also evaluated by testing at 12-h intervals PR platelet units inoculated with low levels of the 3 species reported in the fatal PR platelet: ACBC, Staphylococcus saprophyticus, and Leclercia adecarboxylata.Results: The test detected several Acinetobacter strains at the clinically relevant CFU/ml levels associated with septic transfusions and successfully detected Acinetobacter growing in various non-PR platelet types after an initial low inoculum. In PR platelets, the test yielded a positive result with the 3 implicated bacteria in 48 h or less after inoculation, or 48-72 h earlier than the reported time of transfusion of contaminated PR platelets. Conclusion: PGDprime was improved to detect Acinetobacter and has shown utility to interdict contaminated PR platelets.

Posttransfusion sepsis attributable to bacterial contamination in platelet collection set manufacturing, United States

“…As a result of this case investigation, the manufacturer of the secondary rapid test updated the device to improve detection of Acinetobacter spp. and demonstrated that the rapid test also detected S. saprophyticus and Leclercia adecarboxylata 7 . In addition, CDC, state health departments, blood establishments, and transfusion services involved in the investigation reported a detailed summary of the cases in MMWR and noted their genetic relatedness and an unidentified potential common source 8 …”

“…and demonstrated that the rapid test also detected S. saprophyticus and Leclercia adecarboxylata. 7 In addition, CDC, state health departments, blood establishments, and transfusion services involved in the investigation reported a detailed summary of the cases in MMWR and noted their genetic relatedness and an unidentified potential common source. 8 Considering the findings of the investigation up to that point, in 2019, FDA conducted for-cause inspections at the Fenwal manufacturing facilities for the Amicus collection sets and solutions in Maricao, Puerto Rico, and Haina, Dominican Republic.…”

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

“…More recently, an enhanced PGDprime test was developed to include recognition of Acinetobacter spp. because this bacterium has been implicated in several transfusion reactions in the United States in recent years, including one that was missed with the PGD test [20,21]. A comprehensive review of the PGD assays has been recently published by Mintz and Vallejo [18].…”

Identification and management of bacterially contaminated platelets—Back to the future

“…However, the use of rapid tests or culture did not prevent all septic reactions, because some organisms, like Acinetobacter , either were not detected by the rapid test, or the concentration of bacteria were below the level of detection of the assay 18 . A more recent version of the rapid test has been developed, and this new generation assay is reportedly able to detect this organism 19 …”

“…18 A more recent version of the rapid test has been developed, and this new generation assay is reportedly able to detect this organism. 19 False-negative cultures can result in platelet units that cause sepsis in recipients. The observations that the same culture results were not always seen in both bags when split platelet units were cultured and that recipient sepsis occurred despite negative bacterial culture results led investigators to hypothesize that initial levels of bacteria contaminating platelet units may be very low at the time of testing, resulting in less than one organism in the sampling volume.…”