Background/Case Studies: Given the expanding range of disasters in the U.S., blood banks must have an emergency management plan for blood supply. The need for platelets in disaster events is particularly complicated since platelets have a relatively short shelf life and are at risk for bacterial growth due to storage at room temperature. In response to the 2019 FDA guidance, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” blood centers developed processes for ensuring the safety of platelet products. Many blood collection facilities implemented Large Volume Delayed Sampling (LVDS) and require a minimum of 60 hours prior to release for transfusion. In an emergency event, geographically isolated populations might not have the ability to wait for culture results to support disaster victims, and remote locations will have difficulty importing from other blood centers to meet immediate need. Although emergency release of products prior to culture result availability is always possible, a mechanism to allow early release of platelets while initially ensuring the safety of the product is ideal. The Verax PGDprime (VPGD) Test provides a rapid, reliable means of ensuring the safety of platelet products in emergency situations where conventional LVDS culture is not feasible.
Study
Design/Methods: Results of VPGD tests conducted in-house between 10/1/2021 and 7/31/2023, as well as data from 7 in-state hospitals, were reviewed. The results of VPGD were correlated with aerobic and anaerobic culture results from the BacT/Alert (bioMérieux), incubated for 7 days after collection. A total of 16571 platelet units were labeled and cultured on the BacT/Alert during this timeframe. Of the total platelets labeled, 5232 (31.6%) of platelets were tested with VPGD for expiration date extension.
Results/Findings: Of 5232 platelets tested with VPGD, 4 (0.08%) products tested positive for possible bacterial contamination (Table 1). Three cases were negative by culture and repeat VPGD. One case tested repeat reactive at a hospital on day 6, Staphylococcus epidermidis was isolated in the culture. The sister unit tested negative by VPGD, and the third part of the unit was transfused with no evidence of reaction. All aerobic and anaerobic bacterial cultures inoculated at the blood collection facility were negative at 7 days. It was determined that the positive VPGD and culture was likely due to contamination during the handling/sampling of the platelet bag. Conclusions:
VPGD is a reliable and sensitive rapid method with a strong correlation to culture results from the BacT/Alert.
Utilizing VPGD to release platelets in emergency situations can provide a level of initial assurance of product safety similar to conventional culture methods.
A larger sample size is recommended for further testing correlation.
