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Published on: August 24, 2015
Long-term Experience with Rapid Screening for Platelet Bacterial Contamination in a High-volume Transfusion Service
Reem Alrabeh1,2, Laura Korte1, Meredith Reyes1
1Department of Cardiology, CHI St. Luke's Health - Baylor St. Luke's Medical Center, Houston, TX, USA.
Insights
The Pan Genera Detection (PGD) test effectively screens platelets for bacterial contamination, enhancing transfusion safety. This method proved feasible and efficient in a high-volume setting, reducing transfusion-transmitted infections.
Area of Science:
- Transfusion Medicine
- Microbiology
- Clinical Laboratory Science
Background:
- Bacterial sepsis following platelet transfusion is a significant cause of transfusion-transmitted infections in the United States.
- The U.S. Food and Drug Administration (FDA) recommends bacterial quality control for platelets on storage days 4 and 5.
- Current culture-based methods can be time-consuming, potentially delaying the release of vital platelet products.
Purpose of the Study:
- To evaluate the feasibility and efficiency of the Pan Genera Detection (PGD) test for primary and secondary bacterial screening of platelet units.
- To assess the PGD test's performance in a high-volume transfusion service setting.
- To determine the repeat reactivity and positive predictive value of the PGD test for platelet bacterial contamination.
Main Methods:
- A retrospective review of records from January 2010 to December 2015 was conducted.
- The Pan Genera Detection (PGD) test, an FDA-approved immunoassay, was implemented for screening apheresis and pooled whole blood-derived platelets.
- Testing protocols evolved, with PGD implemented at different storage days (daily, day 5, day 4) and for post-storage pooled platelets on the day of use.
Main Results:
- Over 16,800 PGD tests were performed during the study period.
- An initial reactive rate of 0.25% (42/16,839) was observed, with a repeat reactivity rate of 0.15% (26/42).
- Only one unit with repeat reactivity grew coagulase-negative *Staphylococcus*, and no transfusion-transmitted infections were reported.
Conclusions:
- The Pan Genera Detection (PGD) test is a feasible and efficient method for bacterial screening of platelets in high-volume settings.
- Implementation of the PGD test can enhance transfusion safety by detecting bacterial contamination.
- The PGD assay demonstrates a low repeat reactivity rate and effectively contributes to preventing transfusion-transmitted bacterial infections.
Abstract:
Bacterial sepsis after platelet transfusion is a major cause of transfusion-transmitted infections in the US. The Food and Drug Administration (FDA) recommends performing quality control for platelet bacterial detection on days 4 and 5 before platelet transfusion. We assessed the feasibility of implementing the Pan Genera Detection (PGD) test, an FDA-approved immunoassay for platelet bacterial detection, for the primary and secondary bacterial screening of platelet units in a high-volume setting. Records were reviewed from January 2010 through December 2015. All apheresis platelets underwent primary screening by using culture methods. Additional screening with the PGD test was performed daily until February 2013, when PGD testing of apheresis platelets was performed at the start of storage day 5. In April 2015, PGD testing of apheresis platelet products was performed at the start of storage day 4. Post-storage pooled whole blood-derived platelets were screened by using the PGD test on the day of use. During the 6-year study period, 16,839 PGD tests were performed. If the PGD test was reactive, repeat PGD testing was performed. In cases of repeat reactivity, units were quarantined and cultured. Initially, 42 (0.25%) tests were reactive; 26/42 (61.91%) were repeatedly reactive and resulted in an overall PGD repeat reactivity rate of 0.15%. Only one sample grew coagulase-negative Staphylococcus No transfusion-transmitted infections were reported. The PGD bacterial detection assay was feasible and efficient in our high-volume transfusion service.
