Annual Report on the External Quality Assessment Scheme for Biochemical Genetics in Korea (2014)
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1 ANNUAL REPORT Annual Report on the External Quality Assessment Scheme for Biochemical Genetics in Korea (2014) Soo-Youn Lee 1, Ok Ja Ji 1, Gye Cheol Kwon 2, Jong- Won Kim 1, Hyung-Doo Park 1, Junghan Song 3, Sang-Guk Lee 4, Yong- Wha Lee 5, Eun Hee Lee 6, Sail Chun 7, and Tae Youn Choi 8, as Biochemical Genetics Subcommittee, The Korean Association of External Quality Assessment Service 1 Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; 2 Medicine, Chungnam National University Hospital, Daejeon; 3 Department of Laboratory Medicine, Seoul Natinal University Bundang Hospital, Seongnam; 4 Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul; 5 Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon; 6 Green Cross Laboratories, Yongin; 7 Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine; 8 Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea Two trials of external quality assessment (EQA) of conventional newborn screening tests for phenylketonuria, galactosaemia, congenital adrenal hyperplasia, maple syrup urine disease, homocystinuria, and congenital hypothyroidism, as well as newborn screening tests were performed using tandem mass spectrometry in A total of 39 specimens in the form of dried blood spots were distributed to 16 laboratories and the response rate of these laboratories was 100%. Screening tests for phenylketonuria and congenital hypothyroidism did not meet the accepted performance criteria in some laboratories. The mean, standard deviation, coefficient of variation, median, and cut-offs were evaluated for each analyte in the newborn screening tests. Two trials of EQA for the analyses of methylmalonic acid, vanillylmandelic acid, catecholamines, metanephrines, organic acids, and amino acids were also performed. A well-designed EQA program and continuous education would improve the performance of biochemical genetic testing. (J Lab Med Qual Assur 2015;37:56-63) Key Words: External quality assessment, Newborn screening, Tandem mass spectrometry, Biochemical genetics Corresponding author: Soo-Youn Lee Medicine & Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul , Korea Tel: Fax: suddenbz@skku.edu pissn: eissn: Copyright 2015 The Korean Association of External Quality Assessment Service
2 서론 재료및방법 1. 대상및검체 Table 1. Test items and specimens included in the proficiency tests in 2014 Test items Category Specimen Number Neonatal screening Conventional Phenylketonuria Dried blood spot 24 Congenital hypothyroidism (thyroid-stimulating hormone, total T4, or free T4) 15 Galactosaemia 24 Congenital adrenal hyperplasia (17-hydroxyprogesterone) 24 Maple syrup urine disease 24 Homocystinuria 24 Expanded About 40 inherited metabolic disorders (13 amino acids, 18 acylcarnitines) Dried blood spot 24 Other items Vanillylmandelic acid Urine 6 Methylmalonic acid Urine 6 Organic acids About 70 organic acids Urine 4 Amino acids About 40 amino acids Plasma 4 Catecholamines Dopamine, epinephrine, norepinephrine Urine 6 Metanephrines Metanephrine, normetanephrine Urine 6 J Lab Med Qual Assur 2015;37:
3 2. 결과판정및분석 결과 1. 참여기관및회신율 2. 검사법및장비현황 No. of institutions Response rate (%) Year Fig. 1. The number of institutions that participated in the program conducted by the Korean Association of Quality Assurance for newborn screening tests and their corresponding response rates ( ). 58 J Lab Med Qual Assur 2015;37:
4 Phenylketonuria Maple syrup urine disease Homocystinuria Galactosemia Congenital hypothyroidism Congenital adrenal hyperplasia 1 1 ECA-B ECA-M ECA-Y EIA FlA MS/MS Others Year Fig. 2. The analytical methods used for conventional neonatal screening tests in Abbreviations: ECA-B, enzyme colorimetric assay using a Bio-Rad kit; ECA-M: enzyme colorimetric assay using a MP Biomedicals kit; ECA-Y, enzyme colorimetric assay using a Bayer kit; EIA, enzyme immunoassay using a Bio-Rad kit; FIA, fluorometric immunoassay using a Perkin-Elmer kit; MS/MS, tandem mass spectrometry 신빙도조사결과 고찰 Table 2. Results of the proficiency testing of conventional neonatal screening tests Variable No. of institutions 1st trial Proportion of correct answers (%) No. of institutions 2nd trial Proportion of correct answers (%) Phenylketonuria /191 (99) /176 (93) Galactosaemia /168 (100) /180 (100) Congenital adrenal hyperplasia /152 (99) /168 (100) Maple syrup urine disease /180 (100) /168 (99) Homocystinuria /179 (98) /180 (100) Congenital hypothyroidism Thyroid-stimulating hormone 14 83/83 (100) /135 (100) T4, total 6 29/29 (100) 7 63/63 (100) T4, free 8 20/21 (95) 7 57/63 (90) J Lab Med Qual Assur 2015;37:
5 Table 3. Results of the proficiency testing of expanded neonatal screening tests using tandem mass spectrometry Variable No. of institutions 1st trial Proportion of correct answers (%) No. of institutions 2nd trial Proportion of correct answers (%) Amino acids Arginine /168 (100) /168 (99) Tyrosine /180 (100) /180 (100) Phenylalanine /192 (99) /176 (92) Methionine /179 (99) /180 (100) Citrulline /180 (99) /180 (100) Glycine /179 (99) /180 (99) Ornithine /180 (99) /180 (100) Valine /180 (100) /165 (97) Leucine+isoleucine /180 (100) /165 (99) Phenylalanine/tyrosine /180 (100) /180 (99) Methionine/phenylalanine /168 (99) /168 (100) Alanine /168 (100) /140 (83) Histidine /168 (100) /168 (100) Proline /168 (100) /168 (100) Aspartate 5 60/60 (100) 5 60/60 (100) Glutamate 6 72/72 (100) 6 72/72 (100) Acylcarnitines C /165 (100) /180 (99) C /180 (100) /180 (100) C /180 (100) /180 (100) C /180 (99) /180 (99) C /180 (100) /180 (100) C /180 (100) /180 (99) C /180 (86) /180 (85) C /180 (100) /180 (100) C /168 (100) /168 (100) C /180 (99) /180 (99) C /180 (100) /180 (100) C /180 (100) /180 (100) C5DC /180 (100) /180 (100) C5-OH /179 (99) /168 (98) C3/C /168 (99) /168 (99) 60 J Lab Med Qual Assur 2015;37:
6 Table 4. Cut-offs used in expanded neonatal screening tests using tandem mass spectrometry Variable Mean Median Minimum Maximum Amino acids (μmol/l) Arginine Tyrosine Phenylalanine Methionine Citrulline Glycine , , Ornithine Valine Leucine+isoleucine Phenylalanine/tyrosine Methionine/phenylalanine Alanine Histidine Proline Aspartate Glutamate Acylcarnitines (μmol/l) C C C C C C C C C C C C C5DC C5-OH C3/C J Lab Med Qual Assur 2015;37:
7 감사의글 생화학유전분과위원회위원 (2014) SUPPLEMENTARY MATERIALS REFERENCES 1. Song J, Kwon KC, Kim JH, Kim JW, Min WK, Lee SY, et al. Annual report on external quality assessment in metabolic disorders in Korea (2007). J Lab Med Qual Assur 2008;30: Lee SY, Kwon KC, Kim JH, Kim JW, Park BT, Park HD, et al. Annual report on external quality assessment in biochemical genetics in Korea (2011). J Lab Med Qual Assur 2012;34:S Lee SY, Kwon KC, Kim JH, Kim JW, Park BT, Park HD, et al. Annual report on external quality assessment in biochemical genetics in Korea (2012). J Lab Med Qual Assur 2013;35:S Lee SY; Biochemical Genetics Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratory. Annual report on external quality assessment of biochemical genetics in Korea (2013). J Lab Med Qual Assur 2014;36: J Lab Med Qual Assur 2015;37:
8 생화학유전분과신빙도조사결과보고 (2014) 이수연 1 지옥자 1 권계철 2 김종원 1 박형두 1 송정한 3 이상국 4 이용화 5 이은희 6 전사일 7 최태윤 8 대한임상검사정도관리협회생화학유전분과위원회 1 성균관대학교의과대학삼성서울병원진단검사의학과, 2 충남대학교병원진단검사의학과, 3 분당서울대학교병원진단검사의학과, 4 연세대학교의과대학세브란스병원진단검사의학과, 5 순천향대학교의과대학순천향대학교부천병원진단검사의학과, 6 녹십자의료재단, 7 울산대학교의과대학서울아산병원진단검사의학과, 8 순천향대학교의과대학순천향대학교서울병원진단검사의학과 2014 년도생화학유전학분과신빙도조사사업은총 2 회시행되었다. 페닐케톤뇨증, 갈락토오스혈증, 선천성부신형성과다증, 단풍당뇨증, 호모시스틴뇨증, 선천성갑상선기능저하증을포함하는선천성대사질환기본선별검사와탠덤질량분석기를이용한광범위선별검사를위한총 32 개의건조혈액여과지검체를 16 기관에발송하였다. 회신율은 100% 로, 타기관으로위탁을보내는검사항목은제외하고각기관에서실제로시행하고있는검사들은모두참가하였다. 특히기준치에인접한값을보이는검체들이포함되어결과판정일치율이 70% 미만으로낮아판정보류를한항목들이관찰되었다. 타기관과차이나는측정값또는판정을보이는경우에는기관별측정값, 측정방법, 기준치의차이와그에따른판정결과의차이나결과해석방법등에대해각기관별로면밀한자체검토가필요할것으로판단되었다. 이외메틸말론산과바닐만델산, 유기산, 아미노산, 카테콜라민및메타네프린항목에대한신빙도조사도시행되었으며대부분만족스러운결과를보였다. 외부정도관리프로그램과지속적인교육을통하여생화학유전검사의질을향상시킬수있을것으로기대된다. (J Lab Med Qual Assur 2015;37:56-63) 교신저자 : 이수연우 ) 서울시강남구일원로 81, 성균관대학교의과대학삼성서울병원진단검사의학과 Tel: 02) , Fax: 02) , suddenbz@skku.edu J Lab Med Qual Assur 2015;37:
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