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1 대한수혈학회지 : 제 24 권제 3 호, 2013 The Korean Journal of Blood Transfusion Vol. 24, No. 3, , December 2013 ISSN Original Article 5 년간모든수혈환자를대상으로시행한 Di a 를포함한 Type and Screen 법과 Immediate Spin Crossmatch 적용 김혜림ㆍ김형회 부산대학교의학전문대학원진단검사의학교실 Applied the Type and Screen Method Based on Antibody Screening Test Including Di a Cells and Immediate Spin Crossmatch to All Patients Who Received Transfusion for Five Years Hye-Rim Kim, Hyung-Hoi Kim Department of Laboratory Medicine, School of Medicine, Pusan National University, Busan, Korea Background: To prevent a hemolytic transfusion reaction caused by an unexpected antibody, a crossmatch following ABO/Rh typing and antibody screening test is performed before a red cell transfusion. The conventional crossmatch method is usually performed using the room temperature saline method, 37 o C albumin method, and anti-globulin method. With growth and development of techniques for laboratory and records management, demand for reduction of work load is on the rise, therefore, use of the type and screen method and Immediate spin crossmatch as a pretransfusion test is recommended. Methods: A retrospective analysis was performed using records from the Pusan National University Hospital blood bank from 2008 to Room temperature saline method omitting the anti-globulin crossmatch has been used in order to issue a compatible red cell product, when antibody screening performed using a cell panel (DiaCell I-II-Di a ) in all patients where a request for a red cell transfusion was sent to the blood bank is negative, without previously identified unexpected antibodies. Results: In total, 107,569 units of PRBCs were requested, 100,978 units (93.88%) were issued only immediate-spin crossmatch following type and screen method, and exclusion criteria were indicated in 6.12% of the total. There was no single case where the antibody screen was negative with guarantee of compatibility and hemolytic transfusion reaction occurred. Conclusion: The Type and Screen method based on antibody screening test including Di a cells and Immediate spin crossmatch application can contribute to safe, efficient transfusion service in the blood bank. (Korean J Blood Transfus 2013;24: ) Key words: Type and screen method, Antibody screening, Transfusion, Cross-matching Received on November 16, Revised on December 11, Accepted on December 12, 2013 Correspondence to: Hyung-Hoi Kim Department of Laboratory Medicine, School of Medicine, Pusan National University, 179 Gudeok-ro, Seo-gu, Busan , Korea Tel: , Fax: , hhkim@pusan.ac.kr This work was supported by a 2-Year Research Grant of Pusan National University. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright C 2013 The Korean Society of Blood Transfusion

2 김혜림외 : Di a 를포함한 Type and Screen 법과 Immediate Spin Crossmatch 적용 서론 수혈을시행하는목적은환자에게부족한혈액성분을보충해주어산소운반능력향상, 혈액응고기능유지또는순환혈액량보충등이다. 수혈의학이발전함과함께수혈의효과뿐만아니라부작용과안정성에대한관심도증가되고있다. 수혈을실시하기에앞서수혈받을혈액의적합성여부를평가하는데정확한 ABO 및 RhD 혈액형검사및비예기항체를검출하기위한항체선별검사를시행한다. 혈액이출고되기전에는환자의혈장과수혈될혈액제제간의교차시험을통해응집이일어나는지여부를조사하여안정성을확보한다. 교차시험의주된목적은 ABO 혈액형을다시확인하고비예기항체를검출함으로써수혈로인한부작용을예방하는것이다. 교차시험은전통적으로 3단계에걸쳐시행되는데실온식염수단계 (saline phase), 37 o C 항온알부민단계및항글로불린단계 (Gel phase, Indirect coombs test) 순으로진행한다. 하지만모든수혈예정혈액을대상으로세단계교차시험을시행할경우혈액은행의업무량과부하및수혈되기까지의시간이지연되는결과를초래하게된다. 1) 혈액은행의업무흐름및재고관리를효율적으로조절하기위해예약된적혈구제제의혈액형확인및항체선별검사를시행하고항체선별검사에서음성인환자에한해서 37 o C 항온알부민단계와항글로불린단계를생략하고실온식염수단계 (Immediate spin crossmatch) 만을시행하고적합한혈액제제를출고하는 Type & Screen법 (T & S법 ) 이추천되고있다. 국외에서는 T & S법을통해서안전한수혈이가능함을증명하는연구들이수차례보고되었지만, 2,3) 국내에서는아직이러한연구가없어안정성에대한불안감으로여전히많은의료기관에서수혈전검사로혈액형검 사, 항체선별검사및세단계교차시험을모두통과한혈액을출고하고있다. 혈액제제입고, 출고및재고관리등을적합한전자기록체계가구축되어있으며, 임상적으로중요한항체들을모두검출할수있는항체선별용혈구를포함한민감도가높은항체선별검사를시행하며검사수행및결과에관한기록을보유한다면, 항체선별검사상음성인경우 T & S법이수혈전적합성검사로안전성을보장할수있어권장되는바, 4) 본원에서는모든적혈구제제수혈예정환자들을대상으로시행한항체선별검사에서음성인환자들에한해교차시험으로서 T & S 법과실온식염수단계의교차시험을시행하여혈액제제를출고하고있으며, 본연구에서는 2008 년 1월부터 2012년 12월까지 5년간의경험을분석하여 T & S법으로출고된혈액제제의비율을확인하고, 혈액은행의업무단순화및수혈의안정성확보등을보고하고자하였다. 대상및방법 1. 대상 2008년 1월 1일부터 2012년 12월 31일까지부산대학교병원혈액은행으로혈액이의뢰된환자를대상으로수혈전검사인 ABO 및 RhD 혈액형검사및항체선별검사를시행한 107,569건의적혈구제제를연구대상으로하였다. 2. 방법 1) 검사방법항체선별검사는 LISS/Coombs card (DiaMed, Murten, Switzerland) 에 Dia cell이포함된 cell panel [ID-DiaCell I-II-Di a ] (DiaMed, Murten, Switzerland) 를사용하였으며, 검사법은제조사가제시한

3 Korean J Blood Transfus Vol. 24, No. 3, , Dec Fig. 1. Flow chart of type and screen method, in Blood Bank, PNUH. Abbreviations: Ab ID, antibody identification test; Selection, corresponding antigen negative RBC unit selection; XM, cross matching test; PRBC, packed red blood cells; PNUH, Pusan National University Hospital. 방법을준용하였다. 결과는양성, 약양성, 음성으로보고하였으며양성및약양성결과를보인모든환자를대상으로 LISS/Coombs card와 NaCl/ Enzyme card에 cell panel로는 ID-Dia Panel 1-11 (DiaMed, Murten, Switzerland) 을이용하여항체동정검사를시행하였다. 혈액불출은비예기항체선별검사음성인경우실온식염수단계 (Immediate spin crossmatch) 만을시행하였고비예기항체양성을포함한예외기준인경우실온식염수단계와항글로불린단계의 5) 두단계교차시험을거친뒤적합한혈액을선별하여출고하였다 (Fig. 1). 실온식염수단계교차시험은시험관에생리식염수한방울, 환자혈청한방울, 적혈구한방울을혼합한후 3,100 rpm으로 15초간원심분리후육안으로응집여부를관찰하여 ABO형의오판여부, 생리식염수속에서작용을잘하는항체인항-M, N, s, Lu, P항체등을비롯하여한랭항체및자가항체등을검출하였다. 6) 각환자에게여러단위의혈액제제가의뢰된경우항체선별검사는한번만시행하고, 항체선별검사의결과는 72시간동안유효하게인정되었으며 7) 72시간이경과하였거나이전수혈력이있을경우수혈전항체선별검사를다시시행하였다. 8) 2) T & S법의예외기준항체선별검사에서양성또는약양성으로보고된환자, 이전에항체동정검사결과가있는환자, 이전수혈부작용이력이있는환자, 그리고 ABO 불일치를나타내는환자는 T & S법의적용에서배제되었다. ABO 불일치를나타내는환자들은대개골수이식을받은환자이거나말초혈액도말에서적혈구연전현상을보이는경우이다. T & S 법에서배제된환자들은교차시험단계에서실온식염수단계와항글로불린단계를거쳐서적합한혈액을찾아출고하였다. 3) 수혈부작용사례연구 2008년부터 2012년까지혈액은행에문서로신고된수혈부작용사례를수혈기록및입원기록지로후향적으로조사하였다. 결과 1. T & S법의적용율본원혈액은행에 2008년 1월부터 2012년 12월까지, 지난 5년간의뢰된적혈구제제 (320 ml 및 400 ml) 는총 107,569단위로각환자별로 ABO

4 김혜림외 : Di a 를포함한 Type and Screen 법과 Immediate Spin Crossmatch 적용 Table 1. Applied cross matching results of total request for PRBC over the past 5 years Crossmatch Total Units (%) Units (%) Units (%) Units (%) Units (%) Units (%) Emergency transfusion 263 (1.31) 569 (2.61) 375 (1.67) 520 (2.43) 559 (2.57) 2,286 (2.13) Type & screen 19,215 (95.7) 20,555 (94.2) 21,320 (94.9) 20,156 (94.1) 19,732 (90.6) 100,978 (93.88) Gel matching 521 (2.60) 616 (2.82) 697 (3.10) 683 (3.19) 1,387 (6.37) 3,904 (3.63) 37 o C albumin - (0.00) 8 (0.04) 7 (0.03) - (0.00) - (0.00) 15 (0.01) Least incompatible 78 (0.39) 73 (0.33) 61 (0.27) 65 (0.31) 109 (0.50) 386 (0.36) Total 20,077 21,821 22,460 21,424 21, ,569 Table 2. Number of patients who were transfused with gel cross-matched red blood cells Total (%) Ab positive (65.4) Ab weakly positive (27.9) ABO discrepancy (6.4) Previous transfusion reaction (0.6) Total (100) 및 Rh 혈액형검사및항체선별검사를모두시행하였으며그중 100,978단위 (93.88%) 의적혈구제제가 T & S법을통해실온식염수단계의교차시험만시행후적합한혈액을선별하여출고되었다. 응급수혈을포함한 T & S법의미적용율은 6.12% 로항글로불린및실온식염수두단계교차시험을거치거나추가적으로 37 o C 항온알부민단계까지세단계교차시험을거친뒤출고하였다 (Table 1). 2. 항글로불린교차시험시행분석항글로불린단계와실온식염수단계의교차시험을시행한적혈구를수혈받은환자는총 641 명으로 ABO불일치, 항체선별검사양성및과거수혈부작용병력이있는경우였다 (Table 2). 3. 수혈부작용검토지난 5년간혈액은행에접수된수혈부작용신고건수는총 10건으로적혈구제제를수혈받은환자는 2명이었으며나머지 8명은신선동결혈장또는혈소판제제를수혈받았다. 적혈구제제를수혈받은 2명은고열및전신발진의증상을보였으나수혈후항글로불린검사및교차시험재확인에서모두음성을보여용혈성수혈부작용을배제할수있었다. 고찰수혈전검사의주된목적은용혈성수혈부작용을예방하고수혈된적혈구의생존기간을연장하는것이다. 수혈목적으로혈액제제가의뢰된모

5 Korean J Blood Transfus Vol. 24, No. 3, , Dec 든환자를대상으로 ABO 및 RhD 혈액형검사를시행하고, 임상적으로문제가될수있는비예기항체를검출하기위한항체선별검사를시행한다. 한국인에서발견되는비예기항체의빈도는항-E, -Le a, -Di a, -C, -D, -M, -Le b, -Jk a, -C, -Fy b, Xg a, -S, -P1 등이며비예기항체도임상적으로치명적인수혈부작용을유발할수있다. 9) Di a 항원은백인에서는거의없으며주변동남아시아의평균 2.1% 의발현빈도에비해서 10) 한국인에서는 % 의비교적높은빈도를보이는항원으로 9,11) 이로인한용혈성반응을예방하기위해비예기항체선별검사의항체선별용혈구로 Di a 항원양성혈구를추가하여시행하여임상적으로중요한항체들을수혈전검사에서검출해냈다. Cell panel [ID-DiaCell I-II-Di a ] 을이용한원주응집법의항체선별검사상양성을보일경우저이온강도식염수법, 항글로불린법그리고효소법을조합한항체동정검사를실시하여환자가가지는항체의특이성을확인하여해당항원이없는적혈구를선택해서실온식염수단계와항글로불린단계를포함하는교차시험을시행한다. 과거에항체가동정된환자의혈청에대해서는수혈시마다항체동정검사를반복하지않으며추가항체가생겼을가능성이있을경우항체동정검사를반복하여시행하였다. 7) 항체선별검사상음성을보이는경우가장간단한방법인실온식염수단계만을시행하여적합한혈액을출고하는 T & S를모든수혈예정환자들을대상으로 5년간적용한결과환자에게위해한수혈부작용을일으키는항체를검출해내지못한적은없었다. 이는 cell panel [ID-DiaCell I-II] 에한국인에유의하게높은빈도를보이는 Diego 항체까지병행하여검출하는본원의항체선별검사가매우높은효과를보이며임상적으로중요한항체를모두걸러내는안전한방법임을뒷받침한 다. 비용면에서분석해보면 Diego cell panel을모든수혈예정환자들을대상으로추가적으로시행하게되므로검사재료의비용증가가발생하여적혈구 1단위당 T & S 시행에드는비용은 6,385 6,278원이지만항글로불린단계와함께두단계교차시험을시행하는대신실온식염수단계의교차시험만시행하면업무시간이 25분정도단축되어 1단위당 8,975원의노동비용감소를예측할수있다. 12) 수혈환자의약 98.7% 에서비예기항체선별검사가음성을보이므로 9) 대부분의수혈은 T & S법과실온식염수단계의간략한수혈전검사를적용하여자원을효율적으로이용할수있도록하면서도수혈의안전성을보장할수있다. 또한모든수혈예정환자들을대상으로항체선별검사가의무적으로시행되므로혈액은행의사전예약된혈액제제의준비율이낮아지므로실제수혈이필요한사람에게적절한시점에출고할수있게되고혈액폐기율이유의하게낮아지므로 13) 제한된혈액공급하에서자원의효과적인분배를이룰수있다. 8) T & S 적용은다른국가에서의연구들에서도안정성, 업무량감소, 비용감소및효율적인혈액재고관리면에서의이점이증명되었다. 14,15) 이번연구결과는가까운미래에도입될 Computer cross-match (Electronic crossmatching, exm) 의근거가될수있을것이다. 1992년에제안되어점차세계적으로수혈전검사의시스템으로구축되고있는 exm은 ABO 및 RhD 혈액형검사결과가과거기록과일치하며, 비예기항체가없는경우교차시험을생략하고혈액제제를출고하는것으로혈액은행의업무량, 혈액제제의폐기율, 필요한환자의혈액검체량및전체적인비용을의미있게낮출수있다. 16,17) 본원에서는 5년이상 T & S으로선별검사상비예기항체가음성인환자를대상으로실온식염수단계만을통해혈액을

6 김혜림외 : Di a 를포함한 Type and Screen 법과 Immediate Spin Crossmatch 적용 출고하여왔으며용혈성수혈부작용을야기하는비예기항체를검출하는데실패한적이없다. 그러므로실온식염수단계를생략하고혈액을불출하는 exm을도입하기에무리가없을것으로보인다. 다만 exm의전제조건인동일환자에게요구되는과거 ABO/Rh 혈액형검사의전자기록이구축되어야하므로지역단위또는병원단위등부분적으로적용해나가야할것이며한환자를대상으로두번의 ABO/Rh 혈액형검사가이루어져야하는불편이있지만이는뒤바뀐검체로인한검사오류나 ABO 수혈오류를줄이기위해필요하므로감수해야할것이다. 18) 요약 배경 : 용혈성수혈부작용의발생을예방하기위해수혈전검사로 ABO 및 RhD 혈액형확인, 항체선별검사및교차시험을시행한다. 전통적으로교차시험은실온식염수단계, 37 o C 알부민단계, 그리고항글로불린단계의세단계검사를시행하였지만검사및정보관리기술의발전으로업무량축소의필요성이대두되면서수혈전검사로 Type and Screen법및 Immediate spin crossmatch가권장되고있다. 방법 : 2008년부터 2012년까지본원혈액은행의기록을후향적으로분석하였다. 혈액은행에적혈구수혈이의뢰된모든환자를대상으로시행한 Cell panel [ID-DiaCell I-II-Di a ] 을이용한항체선별검사가음성이면서이전에동정된비예기항체가없는환자에게항글로불린단계를생략하고실온식염수단계의교차시험만시행하여적합한혈액제제를출고하였다. 결과 : 혈액은행에신청된적혈구제제총 107,569 단위중 100,978단위 (93.88%) 가 T & S법을통해실온식염수단계만을시행후출고되었고 6.12% 는예외기준에포함되었다. 항체선별검사결과음성인환자에게적합한혈액으로선별되어출고된이후임상에서의용혈성수혈부작용이보고된사례는없었다. 결론 : Di a 를포함한 Type and Screen법과 Immediate spin crossmatch의적용은안전하고효율적인혈액은행업무에기여한것으로생각된다. References 1. Ness PM, Rosche ME, Barrasso C, Luff RD, Johnson JW Jr. The efficacy of type and screen to reduce unnecessary cross matches for obstetric patients. Am J Obstet Gynecol 1981;140: Pathak S, Chandrashekhar M, Wankhede GR. Type and screen policy in the blood bank: Is AHG cross-match still required? A study at a multispecialty corporate hospital in India. Asian J Transfus Sci 2011;5: Chaudhary R, Agarwal N. Safety of type and screen method compared to conventional antiglobulin crossmatch procedures for compatibility testing in Indian setting. Asian J Transfus Sci 2011;5: Council of Europe. Guide to the preparation, use and quality assurance of blood components : recommendaton No. R (95) th ed. Strasbourg: Council of Europe Publ., 2007: Löw B, Messeter L. Antiglobulin test in lowionic strength salt solution for rapid antibody screening and cross-matching. Vox Sang 1974; 26: Meyer EA, Shulman IA. The sensitivity and specificity of the immediate-spin crossmatch. Transfusion 1989;29: Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories

7 Korean J Blood Transfus Vol. 24, No. 3, , Dec BCSH Blood Transfusion Task Force. Transfus Med 1996;6: American Association of Blood Banks. Standards for blood banks and transfusion services. 24th ed. Bethesda: American Association of Blood Banks, 2006:37 9. Ok SJ, Kim SY, Kim IS, Lee EY, Kim HH. Eleven years' experience with unexpected antibody screening tests including a Di a cell in transfusion candidates. Korean J Blood Transfus 2013;24: Wei CT, Al-Hassan FM, Naim N, Knight A, Joshi SR. Prevalence of Diego blood group antigen and the antibody in three ethnic population groups in Klang valley of Malaysia. Asian J Transfus Sci 2013;7: Yun SG, Ryeu BJ, Yang JH, Lim CS, Kim YK, Lee KN. An experience with unexpected antibody screening tests using a panel that included Di a cells in Koreans. Korean J Blood Transfus 2009;20: Shin KH, Kim HH, Chang CL, Lee EY. Economic and workflow analysis of a blood bank automated system. Ann Lab Med 2013; 33: Choi SH, Seo YH, Ahn JY, Kim KH, Hur HK, Jeon YB, et al. Change of the disposal and the cancellation ratio after enforcement of a precedent antibody screening test. Korean J Blood Transfus 2012;23: Chaudhary R, Agarwal N. Safety of type and screen method compared to conventional antiglobulin crossmatch procedures for compatibility testing in Indian setting. Asian J Transfus Sci 2011;5: Heddle NM, O'Hoski P, Singer J, McBride JA, Ali MA, Kelton JG. A prospective study to determine the safety of omitting the antiglobulin crossmatch from pretransfusion testing. Br J Haematol 1992;81: Roback JD, Grossman BJ, Harris T, Hillyer CD. Pretransfusion testing. In: Roback JD. Technical manual. 17th ed. Bethesda: American Association of Blood Banks, 2011: Reesink HW, Davis K, Wong J, Schwartz DW, Mayr WR, Devine DV, et al. The use of the electronic (computer) cross-match. Vox Sang 2013;104: US FDA. Guidance for industry: Computer crossmatch (computerized analysis of the compatibility between the donor s cell type and the recipient s serum or plasma type). odvaccines/guidancecomplianceregulatoryi nformation/guidances/blood/ucm p df9 [Online] (last visited on 9 December 2013)

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untitled 354 Jae-Jung Kim. Frequency and Distribution of Unexpected Antibody ORIGINAL ARTICLE Korean J Clin Lab Sci. 2018;50(3):354-358 https://doi.org/10.15324/kjcls.2018.50.3.354 pissn 1738-3544 eissn 2288-1662