기증제대혈의 미생물 오염
Microbial Contamination of Donated Umbilical Cord Blood
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배경: 제대혈에서 유래한 동종세포치료제제의 안전성을 검증하기 위해서는 미생물 오염에 대한 검사가 필수적이다. 이에 본 연구에서는 국내 최대의 기증제대혈은행에서 제대혈의 오염 정도와 이에 영향을 미치는 인자를 분석하였다. 또한냉동 저장이 제대혈에 오염된 균에 미치는 영향을 알아보았다. 방법: 제대혈은 제대혈은행의 표준업무지침에 따라 채취, 운반, 처리 및 저장되었다. 미생물 배양 및 동정 검사는 저장전 제대혈 혈장 5-10 mL를 BacT/ALERT 혈액배양병(bioMérieux, France)에 분주하여 통상적인 방법으로 시행하였다. 냉동저장되어 있던 오염 제대혈 중 무작위로 40개를 선택해서 해동하고 2.5 mL를 취하여 상기와 같이 배양 검사를 시행하였다. 결과: 전체 21,236단위 중에서 677단위(3.19%)가 배양 양성이었다. Lactobacillus spp. (17.2%)가 가장 많이 배양되었고, Bacteroides spp. (10.1%), coagulase negative staphylococcus (6.4%)순으로 많이 배양되었으며, 이외 그람양성 간균이 21.4% 에서 배양되었다. 오염률은 제왕절개에서보다 질식분만에서 높았으며(4.1% vs. 0.7% , P＜0.001), 채취 기관별로도 차이가 있었다(0.7-25.4%, P＜0.001). 오염 제대혈의 해동 후 배양에서는 55%에서만 미생물이 배양되었다. 결론: 본 연구는 국내에서 대규모로 제대혈의 오염률을 살펴보았다. 이는 제대혈 채취기관의 질 관리를 위한 기초자료로활용이 가능할 것이다. 냉동 저장 후에 오염 제대혈의 미생물 배양률이 낮아진 것은 추가 연구를 통해 오염 미생물 양의감소를 검증할 필요가 있을 것이다.
Abstract
Background: Testing for possible microorganism contamination in umbilical cord blood (UCB) is essential for validating the product safety of allogeneic cellular therapeutics. We analyzed the level of contamination and related factors at the largest public cord blood bank in Korea. In addition, we also studied the influence of cryopreservation on contaminating microorganisms. Methods: UCB was collected, transported, processed, and stored according to standard operating procedures. Microbial detection and identification was performed using a conventional automated blood culture system (BacT/ALERT; bioMérieux, France) with an inoculum of 5-10 mL plasma for pre-freezing UCB. Forty randomly selected non-conforming units were thawed and studied for microbiologic recovery with an inoculum of 2.5 mL. Results: Among a total of 21,236 UCB, 677 (3.19%) were positive for culture. The most frequently identified organism was Lactobacillus spp. (17.2%), followed by Bacteroides spp. (10.1%), coagulase negative staphylococcus (6.4%), except the unidentified grampositive bacillus (21.4%). The contamination rate was higher in vaginal delivery specimens than in cesarean section specimens (4.1% vs. 0.7%, P＜0.001), and differed by collection center (0.7-25.4%, P＜0.001). Only 55% after-thaw cultures of non-conforming units were positive. Conclusion: We determined the contamination rate of UCB in Korea in a large sample size. The results of this study could be used as baseline data at collection centers for quality control purposes. The low recovery rate of microorganisms after cryopreservation presents a possible way to rescue some non-conforming cord blood units, although further study is needed to confirm the reduction of microbiological burden.
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