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Evaluation of an improved rapid bacterial assay with untreated and pathogen-reduced platelets: Detection of
David LaVerda1, Lisa Shinefeld1, Nancy Best1
1Research and Development Department, Verax Biomedical Incorporated, Marlborough, Massachusetts, USA.
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.
Insights
The updated PGDprime® test now detects Acinetobacter species, improving safety for platelet transfusions. This enhancement helps prevent serious patient harm from contaminated blood products.
Area of Science:
- Microbiology
- Blood Transfusion Safety
- Diagnostic Test Development
Background:
- Recent morbidity and mortality events in 2018 and 2020 were linked to platelets contaminated with Acinetobacter-calcoaceticus-baumannii complex (ACBC).
- The previous PGD test failed to detect ACBC in one critical event.
- Pathogen-reduced (PR) platelets contaminated with ACBC and other bacteria caused patient harm and one fatality.
Purpose of the Study:
- To update the PGDprime® test to include Acinetobacter spp. detection.
- To evaluate the efficacy of the enhanced test in identifying bacterial contamination in platelets, including after pathogen reduction.
Main Methods:
- A polyclonal antibody to Acinetobacter was incorporated into the PGDprime® test device.
- Limit of Detection studies were performed for various Acinetobacter strains.
- The test's ability to detect Acinetobacter growth in platelets and its performance as a secondary test after pathogen reduction were evaluated.
Main Results:
- The updated PGDprime® test successfully detected Acinetobacter strains at clinically relevant levels.
- The test identified Acinetobacter growth in various platelet types after inoculation.
- In pathogen-reduced platelets, the test detected the three implicated bacteria within 48 hours, significantly earlier than transfusion.
Conclusions:
- The PGDprime® test has been successfully improved to detect Acinetobacter.
- The enhanced test demonstrates utility in identifying and interdicting contaminated pathogen-reduced platelets, thereby improving transfusion safety.
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