Kleinman Steven H, Kamel Hany T, Harpool Dennis R, Vanderpool Sandra K, Custer Brian, Wiltbank Thomas B, Nguyen Kim-Anh, Tomasulo Peter A
Blood Systems Research Institute, San Francisco, California, USA.
Transfusion. 2006 Oct;46(10):1787-94. doi: 10.1111/j.1537-2995.2006.00978.x.
Throughout its system of regional centers, Blood Systems implemented culture based bacterial testing with a standardized protocol for both apheresis and whole blood-derived platelets (PLTs).
After a 24-hour hold, 4 mL of PLT product was inoculated into an aerobic bottle (BacT/ALERT, bioMérieux). Cultures were incubated for 24 hours before routine product release to prevent distribution of infected products while minimizing consignee notification, product retrievals, and hospital PLT inventory problems. Initial-positives were further tested (and bacteria identified) by performing cultures from the original component and subcultures from the BacT/ALERT bottle. Results were categorized according to AABB recommended definitions with minor modifications.
The rate of true-positive detections from culturing 122,971 apheresis PLTs was 0.017 percent (95% confidence interval [CI], 0.011%-0.026%). All true-positive microorganisms were Gram-positive with a predominance of coagulase-negative Staphylococcus and Bacillus species. Twenty of the 21 true-positive samples (95%) were detected by 24 hours but only 14 (68%) were detected by 18 hours. The false-positive rate due to contamination was 0.1 percent with the majority of isolates being skin or environmental organisms. Results did not differ significantly for whole blood-derived versus apheresis PLTs.
These data corroborate the fact that the rate of detection of truly contaminated PLT apheresis products in the United States is approximately 1 in 5000 (0.02%); this is lower than the 0.03 to 0.05 percent rates that were generally quoted in the literature before the implementation of prospective bacterial culturing programs.
血液系统公司在其整个区域中心系统中,针对单采血小板和全血来源的血小板(PLT),采用标准化方案实施基于培养的细菌检测。
在保存24小时后,将4 mL血小板产品接种到需氧瓶(BacT/ALERT,生物梅里埃公司)中。培养物培养24小时后再进行常规产品放行,以防止感染产品的分发,同时尽量减少收货方通知、产品回收和医院血小板库存问题。初始阳性结果通过对原始成分进行培养以及从BacT/ALERT瓶中进行传代培养进一步检测(并鉴定细菌)。结果根据美国血库协会(AABB)推荐的定义进行分类,并做了细微修改。
对122,971个单采血小板进行培养,真阳性检测率为0.017%(95%置信区间[CI],0.011% - 0.026%)。所有真阳性微生物均为革兰氏阳性菌,以凝固酶阴性葡萄球菌和芽孢杆菌属为主。21个真阳性样本中有20个(95%)在24小时内被检测到,但只有14个(68%)在18小时内被检测到。污染导致的假阳性率为0.1%,大多数分离株为皮肤或环境微生物。全血来源的血小板与单采血小板的结果无显著差异。
这些数据证实了在美国,真正受污染的单采血小板产品的检测率约为五千分之一(0.02%);这低于前瞻性细菌培养计划实施前文献中普遍引用的0.03%至0.05%的比率。