Mintz Paul D, Sanders Joe R
Verax Biomedical Inc., Marlborough, MA, USA
Verax Biomedical Inc., Marlborough, MA, USA.
Ann Clin Lab Sci. 2020 May;50(3):404-407.
Platelets for transfusion in the US are stored at room temperature which is associated with a risk of bacterial transmission and subsequent sepsis. A recent FDA Final Guidance has been issued with options to mitigate this risk while maintaining or enhancing platelet availability.Storage had been limited to five days for many years due to the risk of bacterial growth. The short shelf-life has resulted in a national outdate rate of approximately 16%. FDA has recently cleared two devices as "safety measures" the use of which now allows seven-day platelet storage in bags cleared for this option. The Platelet PGD Test (Verax Biomedical, Marlborough, MA) is one such device and the other is the bioMérieux BacT/Alert Microbial Detection System (Durham, NC). These "safety measure" options are included in the Final Guidance.In 2018 and 2019, we conducted a survey of 16 blood collection centers and 66 hospitals that use the PGD Test to extend platelet dating to seven days to ascertain how this has resulted in reduced outdating and thereby saved costs. The surveyed institutions were collectively responsible for 21-22% of the annual volume of platelet transfusions in the US.The blood collection centers reported that extension of platelet storage to seven days resulted in a mean outdate reduction of 69% (median 67%, range 23%-92%) and mean cost savings of $415,000 (median $300,000, range $150,000-$900,000). The hospitals reported that extension of platelet storage to seven days resulted in a mean outdate reduction of 74% (median 80%, range 17%-100%) and mean cost savings of $176,803 (median $150,000, range $30,000-$1,200,000). Hospitals saved 24,080 platelet doses annually and blood centers saved 18,700 doses annually. From these institutions alone, this represents a savings of more than 2% of platelet transfusions in the US.Extending platelet shelf-life to seven days with the PGD Test significantly reduced outdating of this valuable resource, increased product availability in accord with FDA Final Guidance recommendations, and saved more money than bacterial testing costs in the surveyed institutions.Results have been presented in part at the Association of Clinical Scientists Annual Meeting, Hershey, PA May 2019.
在美国，用于输血的血小板在室温下储存，这存在细菌传播及随后引发败血症的风险。美国食品药品监督管理局（FDA）近期发布了最终指南，提供了在维持或提高血小板可用性的同时降低这种风险的方法。由于存在细菌生长的风险，多年来血小板储存期限一直限制为五天。较短的保质期导致全国范围内约16%的过期率。FDA最近批准了两种设备作为“安全措施”，使用这两种设备现在允许在为此选项获批的袋子中进行为期七天的血小板储存。血小板PGD检测（Verax Biomedical公司，马萨诸塞州马尔伯勒）就是这样一种设备，另一种是生物梅里埃BacT/Alert微生物检测系统（北卡罗来纳州达勒姆）。这些“安全措施”选项包含在最终指南中。2018年和2019年，我们对16个血液采集中心和66家使用PGD检测将血小板有效期延长至七天的医院进行了一项调查，以确定这如何减少了过期情况并从而节省了成本。这些接受调查的机构总共负责美国每年血小板输血量的21%至22%。血液采集中心报告称，将血小板储存期延长至七天使过期率平均降低了69%（中位数为67%，范围为23%至92%），平均节省成本41.5万美元（中位数为30万美元，范围为15万美元至90万美元）。医院报告称，将血小板储存期延长至七天使过期率平均降低了74%（中位数为80%，范围为十七%至100%），平均节省成本176,803美元（中位数为15万美元，范围为3万美元至120万美元）。医院每年节省24,080个血小板剂量，血液中心每年节省18,700个剂量。仅从这些机构来看，这就代表着美国血小板输血量节省了超过2%。使用PGD检测将血小板保质期延长至七天显著减少了这种宝贵资源的过期情况，根据FDA最终指南建议提高了产品可用性，并且在接受调查的机构中节省的资金超过了细菌检测成本。部分结果已在2019年5月于宾夕法尼亚州赫尔希举行的临床科学家协会年会上公布。
