2017年4月11日，生物医学公司Verax的Platelet PGD®检测(快速检测血小板细菌)技术再次获得了美国FDA的批准，该检测技术因此扩大了应用范围，可以作为一次性设备用于单采去白细胞或非去白细胞全血制备的血小板细菌污染与否的检测。此前，FDA已经批准该项检测技术用于去白细胞或非去白细胞全血制备的血小板的贮后检测。
单一单位的血小板输注常被用于美国医院儿童患者的应用，这次Platelet PGD®检测的批准将帮助减小用于患者输注的血小板被细菌污染的风险，从而降低输注后的感染风险。
Verax公司CEO Jim Lousararian表示：“这次新的使用批准扩展了我们PGD®血小板检测的使用范围，这次批准可以极大满足目前的细菌盘检测技术(PGD)的操作者的应用需求，同时也将被写入FDA解决血小板细菌污染风险的指南草案。”
VeraxPGD®检测是此前已被FDA批准的血小板细菌污染检测的一项安全检测设备，所以这意味着该项技术同样适用于单采血小板7天时间的检测。
Verax公司首席医学官Paul Mintz博士表示：“对儿童患者进行输血是具有挑战性的工作，他们需要更低剂量的血小板，同时他们的免疫系统也更加脆弱，而PGD检测技术用于儿童患者的单采全血制备的血小板输注前的细菌检测，是完全可以实现的。”
Verax公司专利化的Pan genera(R)detection(PGD)技术，对广泛的细菌具有独特及确切的检出能力，因此该技术可以理想的实现对血小板广泛细菌污染的快速检测，成本效益更佳。PGD检测技术必须在进行血小板输注前一次性使用，可以大大减少检测人员的工作量，可以极大地满足现今血液输注细菌检测市场。
Platelet PGD Test
During a major multi-center study of Platelet PGD Test performance on the day of transfusion:
Over a 2 year period 18 US hospitals participated in a study using the PGD test on the day of transfusion. The objective of the study was to eva luate the test's ability to detect bacterially contaminated units in the US apheresis inventory that tested negative for contamination by existing growth based QC tests. A total of 9 contaminated units were detected by PGD and confirmed as bacterially contaminated in a population of 27,620 leukoreduced apheresis units (1:3,069 doses tested). Seven of these 9 units were determined to have very high levels of contamination that have been associated with serious to fatal transfusion reactions3. All 9 units had previously tested negative by growth based QC methods applied earlier in unit life in conformance with all applicable AABB and CAP standards for bacterial testing. The study clearly demonstrated the ability of the Platelet PGD Test to detect and interdict contaminated units missed by current QC testing methods. The study findings have been accepted for publication in the journal Transfusion.
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The Platelet PGD Test meets all of the critical requirements for platelet bacterial detection:
Broad detection-only one test to detect aerobic and anaerobic bacteria
Sensitive-Detected 9 culture false negative units in a population of 27,620 apheresis platelets
99.3-99.8% specificity-based on the repeat reactive rate in LRAP units
Rapid results—1 test in 30 minutes, a batch of 12 in less than an 1 hour
Ease of use—<3 minutes of attended labor for one test, < 15 minutes for a batch of 12
Small sample size-only 500 uL
No dedicated instrument required-simple visual results
Built in procedural controls-confirm sample addition and test completion
The test consists of a disposable plastic cartridge that can be stored at room temperature and three dropper bottle sample pretreatment reagents. The Platelet PGD test procedure involves pre-treating a freshly collected 500uL platelet sample and applying it to the sample well on the test cartridge. Within approximately 20 minutes of sample addition, a pink colored line will appear in one of the two reading windows on the test cartridge if either Gram-positive or Gram-negative bacteria are detected in the sample above the cut-off level of the assay. Non-reactive samples show no color line in the result windows. Procedural Controls which change from yellow to blue violet when the test is ready to be interpreted are included at each end of the test cartridge. These allow visual confirmation that the appropriate volume of sample was added to the cartridge and that the test has run to completion. |
