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Update on the AABB Standards and platelet bacterial contamination TAC: MVRBC 2011 Standard 5.1.5.1 • The blood bank or transfusion service shall have methods to limit and to detect or inactivate bacteria in all platelet components. • Standard 5.6.2 applies. –Venipuncture skin prep and diversion Association Bulletin 09-04 “…after publication of data sufficiently robust…the current standard will be reappraised. At that time, AABB intends to promulgate an interim standard to require enhanced methods of bacterial detection in WBD platelets—either by specifically prohibiting the use of less sensitive methods such as pH or glucose, or by establishing a minimum sensitivity level for methods used to detect bacteria. • At this time, transfusion services using uncultured WBD platelets should begin to consider their options.” Interim Standard 5.1.5.1.1 • Detection methods shall either be approved by the FDA or validated to provide sensitivity equivalent to FDA-approved methods. Effective date of January 31, 2011. FDA fatality surveillance FY 2005-10 40 35 FY05 30 FY06 25 FY07 FY08 20 FY09 15 FY10 10 5 0 Bacterial deaths reported to FDA 7 6 RDP Apheresis 5 4 3 Average 2001-05 = 6/year 2 1 0 2005 2006 2007 2008 2009 http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/ TransfusionDonationFatalities/ucm204763.htm Contamination rate/106 based on early (release) culture: optimal arm prep and diversion pouch 1200 1000 1000 800 800 640 648 600 400 211 200 0 Corash, L. Expert Rev. Heme. 2011 855 900 Rates/106 of bacterial contamination detected with culture-based testing at expiration 2500 2000 2200 1500 1580 1000 500 1140 1200 900 662 0 PASSPORT Wales Corash, L. Expert Rev. Heme. 2011 German Irish BTS 4apheresis day retest German pools Irish BTS Confirmed cultures (per sample tested) WBD vs. apheresis platelets WBD Study Pool size Method N Apheresis Rate/ 106 N Rate/ 106 OR (95%CI) 5.8 Benjamin, US 5 PRP 20,725 965 431,490 167 Yomtovian, US 5 PRP 12,961 2,392 15,493 452 Schrezenmeier, Germany 5 BC 22,044 726 15,198 855 NS Murphy, Ireland 5 BC 30,407 329 12,823 312 NS de Korte, Netherlands 5 BC 6,749 1,322 4,963 2,418 Adapted from Benjamin et al. Transfusion. 2008 (3.5-9.5) 5.3 (2.3-12.0) NS Verax PGD®: 10 November 2009 Clinical vs. analytical sensitivity Yomtovian et al. CID. 2008. LOD for bacteria in platelets with Verax PGD® Verax PGD PI. 2010. Performance of Verax PGD® at ITxM WBD platelet pools Test PGD WBD platelets Positive Positive screened tests cultures 7733 14 2 Spec. PPV p 99.85 14.3 .014 pH 37060 405 4 98.93 1.0 After Yazer et al. AJCP. 2010 Verax PGD and apheresis platelets (negative release culture at time of issue) AP doses w/ valid PGD 27,620 Repeat reactive PGD 152 Negative PGD 27,469 .55% Recultured 10,344 Culture positive 9 True pos PGD Culture negative 142 False pos PGD Culture positive 2 False neg PGD Culture negative 10,342 True neg PGD .033% .514% .019% 99.980% Jacobs et al. Transfusion. 2011 Options to meet the intent of 5.1.5.1.1 • PGD® within 4 h. of transfusion on WBD pools: point of issue; • Prepooled WBD platelets tested by supplier with approved culture-based QC test; • Culture aliquots from WBD units at pooling; • Use methods not FDA-cleared but validated to be of equivalent sensitivity to an approved assay, subject to review at the time of accreditation assessments. • Use apheresis platelets tested by supplier with approved culture-based QC test; • Should PGD (or equivalent) be used in transfusion service? What else? • pH, glucose and microscopy will NOT be acceptable • Use of untested WBD pools (e.g. ≤3 days) will require validation • Use of Verax at ≤72 hr. may detect clinically important bacteria, and should be considered when other sensitive alternatives are not available • Optimal practice is to test WBD pools before LR (per PI); testing after LR may be considered if workflow or clinical constraints demand • Urgent platelet release without or during QC testing is “practice of medicine” and is acceptable if addressed in facility SOPs. [email protected]
