| Popis: |
BACKGROUND Apheresis platelet (AP) contamination may be influenced by manufacturing methods because bacteria are subject to the same forces that permit separation of blood cells. This study assesses whether apheresis technology influences in-process detection of bacterial contamination. STUDY DESIGN AND METHODS Blood Systems, Inc. (BSI) and New York Blood Center (NYBC) use Amicus and Trima devices to collect APs. Manufacturing (arm disinfection and in-line diversion) was consistent for both devices in the study period. Detection was performed using BacT/ALERT. True-positive (TP) rates were calculated and significance testing was performed using chi-square tests separately for BSI and NYBC. For BSI, multivariable logistic regression analysis was also performed to identify factors associated with TP results. RESULTS For BSI, there were 49 TPs in 354,946 donations (1.4/10,000): 2.5 per 10,000 for Amicus and 1.0 per 10,000 for Trima (p |
Plný text