REPORT ON PROFICIENCY TESTING Annual Report on the External Quality Assessment Scheme for Urinalysis and

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1 REPORT ON PROFICIENCY TESTING Annual Report on the External Quality Assessment Scheme for Urinalysis and Faecal Occult Blood Testing in Korea (2016) Chang-Ho Jeon, A-Jin Lee, Sang-Gyung Kim, Hun-Seok Suh, and Young-Cheol Bae Department of Laboratory Medicine, Daegu Catholic University School of Medicine, Daegu, Korea Corresponding author: Chang-Ho Jeon Department of Laboratory Medicine, Daegu Catholic University Medical Center, 33 Duryugongwon-ro 17-gil, Namgu, Daegu 42472, Korea Tel: Fax: In 2016, external quality assessment trials for urinalysis and faecal occult blood (FOB) were performed with 1,487 participants in Korea. Urine chemistry and FOB tests were performed three and two times, respectively, whereas urine sediment was evaluated once using photography. Urine chemistry tests consisted of ph, protein, glucose, ketone, bilirubin, blood, urobilinogen, and nitrite levels; leukocyte count; specific gravity. The results of the urine chemistry and specific gravity tests showed accuracy rates of >95%. The accuracy rate of urine sediments was low, especially that for transitional epithelial cells and atypical crystals. In the FOB quality test, all reagents showed accuracy rates of >90%, which suggested the improvement of false-positive reaction. In the FOB quantitative test, discrepant results depending on the instrument used was observed. To compensate for the result differences caused by the stool samples, the results should be reported using another unit (mg/g of stool). (J Lab Med Qual Assur 2017;39: ) Key Words: Quality assessment, Urinalysis, Occult blood pissn: eissn: 서론 요경검학분과의 2016년도외부정도관리사업은새로운전산입력시스템을도입하여시행되었다. 새로운전산시스템의도입되었으나결과분석및보고가적시에이루어지지않아많은기관에서불편을호소하였다. 이런문제가늦은감이있지만모두해결되어하반기에는잘진행될수있었다. 2015년신빙도조사사업에서대변잠혈검사 (faecal occult blood, FOB) 는음성검체에서 11.0%-72.3% 의정답률을나타내었고, 요침사판독에서 82.6%-98.1% 의정답률을각각나타내어 [1] 정답률이가장낮았던 FOB의위양성문제를보완하고자하였다. 따라서 2016년외부정도관리사업을위하여 3차에걸쳐 12 개의관리물질을사용하여요화학검사를시행하였고, 요침사검사는 1회 4개의물질로시행하였다. 또한 2회에걸쳐 6개 의관리물질을사용하여 FOB를시행하였다. 요화학검사및 FOB 신빙도조사에는국내에서제조된관리물질을사용하였다. 요침사검사는요침사사진 4매를본협회홈페이지에게시하여판독하도록하였다. 재료및방법 1. 대상요경검학분과에서는대한임상검사정도관리협회에등록된기관을대상으로 2016년도 4월, 6월, 8월 3차에걸쳐정도관리물질을발송하였다. 발송기관수는 1,487기관으로 15 년도 1,265기관에비하여 222기관이증가되었으며회신율은 97.8% 였다. Copyright 2017 Korean Association of External Quality Assessment Service 117

2 2. 재료요화학검사를위한관리물질은 1차 (CU ), 2차 (CU ), 3차 (CU ) 검체모두국내에서제조한액상관리물질 4종씩을각회원기관에냉장포장하여발송하였다. 이중 2차에는액상검체외에본협회홈페이지에제시한요침사사진 4매등모두 22종의검체를우송및제시하여정도관리신빙도조사를시행하였다. 결과치의입력은본협회에서새롭게구축된신빙도조사사업홈페이지에서직접입력하는방식을사용하였다. FOB를위한관리물질도 1차및 2 차검체모두국내에서제조한점액성분말관리물질 3종 (CS ) 을각회원기관에냉장포장하여발송하였다. 3. 정도관리물질의허용치요화학및 FOB검사의경우분과위원회에서실험한참고치, 각기관에서회신한결과의일치도를고려하였으며, 가능하면전기관의 95%-99% 가허용범위에들어올수있도록허용치를설정하였다. FOB 및굴절계에의한비중은평균 ±2SD의범위를허용범위로설정하였다. 결과 1. 요화학검사 9종의신빙도조사성적요화학검사 9종 (ph, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte) 의신빙도조사성적은 Table 1에요약하였다. Table 1은 1차및 3차의모든정도관리 Table 1. Number of participants and acceptable rates of urine chemistry QC Tests 1st QC 2nd QC 3rd QC Participants Acceptable (%) Participants Acceptable (%) Participants Acceptable (%) ph 1, , , Protein 1, , , Glucose 1, , , Ketone 1, , , Bilirubin 1, , , Blood 1, , , Urobilinogen 1, , , Nitrite 1, , , Leukocyte 1, , , Abbreviation: QC, quality control. Table 2. Acceptable rates according to the urine chemistry analysers of different companies Company ph Protein Glucose Ketone Bilirubin Blood Urobilinogen Nitrite Leukocyte Total (%) YD (39.8) SD (15.8) Roche (15.2) DFI (8.6) Siemens (6.6) Eiken (4.1) Arkray (3.0) Beckman (0.5) Others (5.8) Values are presented as % or number (%). The instruments used were from the following companies: YD (YD Diagnostics, Yongin, Korea), SD (Standard Diagnostics, Seoul, Korea), Roche (Roche diagnostics, Mannheim, Germany), DFI (DFI Co. Ltd., Gimhae, Korea), Siemens (Siemens Healthcare (Erlangen, Germany), Eiken (Eiken Chemical Co., Tokyo, Japan), Arkray (Arkray Inc., Kyoto, Japan), and Beckman (Beckman Coulter Inc., Brea, CA). 118 J Lab Med Qual Assur 2017;39:

3 검체의평균정답률을구한자료이며, 모든항목에서 97% 이 상의정답률을나타내었다. calcium oxalate 결정체는비정형형태가출제되어가장낮은 8.7% 의정답률을보였다. 2. 요화학분석기에따른요화학검사신빙도조사성적각회사별요화학분석기에따른요화학검사의신빙도조사성적은 Table 2와같다. YD (YD Diagnostics, Yongin, Korea) 가 39.8% 로가장많이사용하고있으며, SD (Standard Diagnostics, Seoul, Korea) 15.8%, Roche (Roche, Mannheim, Germany) 15.2%, DFI (DFI Co. Ltd., Gimhae, Korea) 8.6% 순이었다. 회사별장비에따라요화학검사의정답률은차이를보이지않았으나 Beckman 장비 (Beckman Coulter Inc., Brea, CA, USA) 는백혈구검출에서 75% 의낮은정답률을나타내었으며, 이는백혈구양성검체를음성으로판독한데서기인하였다. 3. 요화학분석기로시행한요비중검사신빙도조사성적요비중검사는굴절계검사는시행하지않고요화학분석장기로측정하였다. Table 3에서와같이모든검체에서 95% 이상의정답률을나타내었다. 4. 사진검체를이용한요침사물검사결과사진검체를사용하여시행한요침사물신빙도조사의평균정답률은 8.7% 에서 86.7% 의정답률을보였다 (Table 4). Transitional epithelial cell 및 renal tubular epithelial cell을 monocyte 혹은 macrophage로판정하였다. 또한 sulfonamide 및 calcium oxalate 결정체의식별은더욱낮은정답률을보였다. Sulfonamide 결정체는자주관찰되지않아서 79.4%, 5. FOB 시약에따른 FOB 정성검사의정답률및시약의분포 FOB 시약에따른 FOB 정성검사의정답률은 Table 5 Table 4. Acceptable rates for the urine sediment examination Replied results Specimen no. Value Sulfonamide* CUI Ca oxalate CUI Bilirubin CUI Correct answer (%) CUI Transitional epi cell* CUI Monocyte/macrophage CUI Renal tubular epi cell* CUI Correct answer (%) CUI Cellular cast* CUI Granular cast CUI RBC/pigmented casts CUI Correct answer (%) CUI Leucine CUI Starch granule CUI Calcium oxalate* CUI Correct answer (%) CUI No. of participants 805 Values are presented as number, unless otherwise stated. *Correct answer. Table 3. Acceptable rates for the urine specific gravity test Specimen Participants Mean±SD 95% Confidence interval Acceptable (%) CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to CU , ± to J Lab Med Qual Assur 2017;39:

4 에나타내었다. 시약은 SD FOB Rapid test (261기관), YD FOB test (115기관), Asan FOB easy test (Asan Pharmaceutical, Seoul, Korea; 58기관 ), Eiken homocatch light (Eiken Chemical Co., Tokyo, Japan; 56기관 ) 순으로사용하였다. 모든시약에서양호한정답률을나타내었으나, FOB 음성검체에서 GC genedia FOB (Green Cross Medial Science Co., Yongin, Korea; 90.9%), Humasis FOB test (Humasis Co., Anyang, Korea; 91.4%), YD FOB test (93.9%) 시약에서다소낮은정답률을나타내었다. 6. FOB 시약에따른 FOB 정량검사의정답률및시약의분포 FOB 정량검사결과분포는 Table 6에요약하였다. 장비별로검사에사용하는대변양이달라서장비간비교가어려워이번에는이를보정한값을함께비교하였다. 사용장비는 Eiken (156기관), Alfresa (Alfresa Pharma Co., Osaka, Japan; 49기관 ), Kyowa (Kyowa Chemical Industry Co., Kagawa, Japan; 34기관 ) 순으로분포하였다. 전체평균에비하여 Alfresa 장비는 CS 및 CS 검체에서높은수치를보였다. 또한 Alfresa 장비는 CS-16-02, 16-03, 및 검체에서모두낮은농도를나타내었다. 고찰 2016년의정도관리신빙도조사에서나타난결과를분석해볼때 2015년정도관리신빙도사업결과에비하여요화학검사및비중검사는우수한정답률을유지하였다. 그러나요침사신 빙도조사에서도 2015년정답률 80.1%-98.1% 보다낮은결과를보였다. FOB 정성검사에서 2015년보다는매우우수한정답률을보여위양성률이대폭감소하였다. 요화학검사에서 9종의검사항목에서 leukocytes를제외하고장비간결과차이를보이지않았다. Beckman 장비에서 leukocytes 양성인검체를음성으로판독하였다. 요화학검사의정도관리검체는 phosphate buffered saline에양성물질을첨가하여제조한것이다. Leukocytes 양성물질은공개되지않아알수없지만, 기질에의한간섭현상으로음성결과를보이는것으로생각되었다. 향후기질에의한간섭현상을방지할수있는정도관리물질을사용하는것으로개선할필요성이있다. 요침사신빙도조사에서는낮은정답률을기록하였는데 transitional epithelial cell을 monocyte 혹은 macrophage로판정하였다. Fig. 1에서관찰된바와같이다핵세포를보여오해할수있으나결석증이나카세터를삽관한환자에서는종종다핵을보이는 transitional epithelial cell을볼수있다 [2]. Sulfonamide 결정체는 sulphonamide 복용환자나화상치료제로쓰이는 sliver sulfadiazine 사용시나타나며 [3], calcium oxalate 결정체는비정형형태가출제되어매우낮은정답률을보였다. Calcium oxalate 결정체는소변에서가장흔한결정체이며비정형형태도자주나타나므로 [4,5] 이에대한주의가필요하다. FOB 정성검사에서 2015년에는전시약에서음성검체를양성으로판독하여오답률이 89.0% 에달하여문제점으로부각되었다. 이를위하여국내시판되는주요 FOB 정성검사시 Table 5. Acceptable rates for the faecal occult blood quality test Reagents No. CS CS CS Negative Acceptable (%) Positive Acceptable (%) Positive Acceptable (%) SD FOB Rapid test YD Occult Tech FOB test ASAN Easy Test FOB Eiken Hemocatch light Humasis FOB test Bio Focus FOB Rapid test HBI HiSens FOB NCard GC Genedia FOB Others Abbreviation: FOB, faecal occult blood. The instruments used were from the following companies: SD (Standard Diagnostics, Seoul, Korea), YD (YD Diagnostics, Yongin, Korea), Asan Pharmaceutical (Seoul, Korea), Eiken Chemical Co. (Tokyo, Japan), Humasis Co. (Anyang, Korea), Bio Focus Co. (Uiwang, Korea), HBI Co. (Anyang, Korea), and GC (Green Cross Medial Science Co., Yongin, Korea). 120 J Lab Med Qual Assur 2017;39:

5 Table 6. Distribution of the results of the faecal occult blood quantitation tests Instruments Specimen no. No. Median Minimum Maximum Average ng/ml µg/g stool ng/ml µg/g stool ng/ml µg/g stool ng/ml µg/g stool Eiken CS Alfresa CS Kyowa CS Others CS NA 1 NA 28 NA 17 NA Eiken CS Alfresa CS Kyowa CS Others CS NA 5 NA 498 NA NA Eiken CS Alfresa CS Kyowa CS Others CS NA 43 NA 1,000 NA NA Eiken CS Alfresa CS Kyowa CS Others CS NA 4 NA 72 NA 24.9 NA Eiken CS Alfresa CS Kyowa CS Others CS NA 18 NA 413 NA NA Eiken CS Alfresa CS Kyowa CS Others CS NA 40 NA 916 NA NA Abbreviation: NA, not available. The instruments used were from the following companies: Eiken Chemical Co. (Tokyo, Japan), Alfresa Pharma Co. (Osaka, Japan), and Kyowa Chemical Industry Co. (Kagawa, Japan). 약을대상으로환자검체를사용하여성능검사를시행하여 11 ng/ml 이상일때 14.3%-57.1% 의양성률을보였다. 정성시약의 FOB 검출민감도는 20 ng/ml 이상으로알려져있다 [6]. 정성시약의과도한민감도를낮추기위하여국내 FOB 시약회사들에게민감도조정을요청하였고 2016년에 2회에걸쳐 FOB 음성인검체로신빙도조사사업을시행한결과모두 90% 이상의정답률을보였다. 일단신빙도조사성적에서는위양성문제가해결된것으로보이나시판되는 FOB 시약을사용하여민감도개선여부를확인할필요성이있다. 대변잠혈정량검사에서 Alfresa는저농도검체에서는높게, 중등및고농도검체에서는낮게측정하였다. FOB 정도관리검체는강력분밀가루에혈색소분말을첨가하여제조한것이 다. 검체기질에따른영향을배제할수는없으나, 장비에따른결과차이는다른연구자들에의해서도보고되었다 [7]. FOB 정량검사는측정장비에따라서사용되는대변양이달라서 ng/ml의단위로보고하면주입되는대변양으로인한농도차이를보일수있다. 향후 FOB의또다른보고단위인 mg/g stool을 [8] 도입하여병행하여사용함으로써이문제를해결하고자한다. REFERENCES 1. Jeon CH, Lee AJ; Urinalysis and Routine Microscopy Subcommittee, Korean Association of External Quality J Lab Med Qual Assur 2017;39:

A B C D Fig. 1. Images of urine sediments (with arrow) for the external quality assessment. (A) CUI-16-01 sulfadiazine crystal (original magnification 400).

(D) CUI- 16-04 calcium oxalate crystal (original magnification 400). Assessment Service.

Atlas of urinary sediment. Kobe: Sysmex Corporation, 2014. 3. Perazella MA. Crystal-induced acute renal failure. Am J Med 1999;106:459-65. 4. McPherson RA, Pincus MR.

Philadelphia (PA): Wolters Kluwer, 2016. 6. Guittet L, Bouvier V, Mariotte N, Vallee JP, Levillain R, Tichet J, et al.

6 A B C D Fig. 1. Images of urine sediments (with arrow) for the external quality assessment. (A) CUI sulfadiazine crystal (original magnification 400). (B) CUI transitional epithelial cell (original magnification 200). (C) CUI white blood cell count cast (original magnification 100). (D) CUI calcium oxalate crystal (original magnification 400). Assessment Service. Annual report on the external quality assessment scheme for urinalysis and faecal occult blood testing in Korea (2015). J Lab Med Qual Assur 2016;38: Itoh K, Miyachi H, Asai S, Nozaki T. Atlas of urinary sediment. Kobe: Sysmex Corporation, Perazella MA. Crystal-induced acute renal failure. Am J Med 1999;106: McPherson RA, Pincus MR. Henry s clinical diagnosis and management by laboratory methods. 23rd ed. St. Louis (MO): Elsevier, 2017: Mundt LA, Shanahan K. Graff s textbook of urinalysis and body fluids. 3rd ed. Philadelphia (PA): Wolters Kluwer, Guittet L, Bouvier V, Mariotte N, Vallee JP, Levillain R, Tichet J, et al. Performance of immunochemical faecal occult blood test in colorectal cancer screening in average-risk population according to positivity threshold and number of samples. Int J Cancer 2009;125: Kim JH, Hwang SY, Kim YJ. Evaluation of Hemo Techt NS-plus C15 Automatic Analyzer for fecal occult blood test. J Lab Med Qual Assur 2010;32: Sinatra MA, Young GP, St John DJ, Blake D, Ratnaike S. A study of laboratory based faecal occult blood testing in Melbourne, Australia. The Faecal Occult Blood Testing Study Group. J Gastroenterol Hepatol 1998;13: J Lab Med Qual Assur 2017;39:

7 요및대변잠혈검사신빙도조사결과보고 (2016) 전창호 이아진 김상경 서헌석 배영철대구가톨릭대학교의과대학진단검사의학교실 2016 년요경검및대변잠혈검사 (faecal occult blood, FOB) 정도관리사업이 1,487 개기관이참여하여시행되었다. 요화학검사 3 회, FOB 검사 2 회에걸쳐시행되었고, 사진판독에의한요침사물판정은 1 회실시하였다. 요화학검사는 ph, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte 및 specific gravity (SG) 등 10 항목이었다. 요화학검사및요시험지봉에의한 SG 검사는 95% 이상의우수한정답률을나타내었으나, 요침사물검사는 transitional epithelial cell 및비정형결정체에서낮은정답률을보였다. FOB 정성검사에서 90% 이상의정답률을보여음성검체에서나타난위양성결과가개선되었다. FOB 정량검사는장비간에농도차이를보였으며, 대변양사용에따른농도차이를보완하기위하여 μg/g stool 로보고할필요가제기되었다. (J Lab Med Qual Assur 2017;39: ) 교신저자 : 전창호우 )42472 대구시남구두류공원로 17 길 33, 대구가톨릭대학교병원진단검사의학과 Tel: 053) , Fax: 053) , chjeon@cu.ac.kr J Lab Med Qual Assur 2017;39:

REPORT ON PROFICIENCY TESTING Annual Report of the Korean Association of External Quality Assessment Servi

REPORT ON PROFICIENCY TESTING https://doi.org/10.15263/jlmqa.2019.41.2.75 Annual Report of the Korean Association of External Quality Assessment Service on Urinalysis and Fecal Occult Blood Testing (2018)