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Report of Korean Association of External Quality Assessment Service on the Accuracy-Based Lipid Proficiency Testing (2016-2018)
J Lab Med Qual Assur 2019;41:121-129
Published online September 30, 2019
© 2019 Korean Association of External Quality Assessment Service.

Jeong-Ho Kim1, Yonggeun Cho1, Sang-Guk Lee1, and Yeo-Min Yun2

1Department of Laboratory Medicine, Yonsei University College of Medicine;
2Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea
Correspondence to: Jeong-Ho Kim
Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea
Tel: +82-2-2228-2448 Fax: +82-2-313-0956 E-mail: jeongho@yuhs.ac
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 Abstract

The accuracy-based lipid (ABL) proficiency testing (PT) program was started in 2016 by the Korean External Quality Assessment Service to minimize the matrix effect. We analyzed 3 years of the program. We made or purchased six kinds of commutable frozen sera based on the Clinical and Laboratory Standards Institute 37A guideline and distributed it in two rounds per year from 2016 to 2018. We obtained reference values for levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC), total glycerides, and triglycerides in each fresh frozen pool at the reference-measurement laboratories. We evaluated the average percent bias of the participating laboratories based on the National Cholesterol Education Program (NCEP) bias limit. The number of participating laboratories evaluating TC, HDLC, LDLC, total glycerides, and triglycerides increased from 164 to 223, 163 to 223, 158 to 214, 98 to 139, and 61 to 82, respectively. The average percent bias of all participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was +0.14%, -0.54%, +2.9%, -1.08%, and -1.32%, respectively. The average percent bias exceeded the NCEP bias limit only once or twice for TC, HDLC, and total glycerides but frequently for LDLC (eight out of 18 pools). The manufacturer-specific bias estimation report seemed useful for traceability. Although the average percent bias of participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was mostly within the bias limit provided by NCEP, cases of bias limit exceeding the NCEP bias limit occurred occasionally, especially for LDLC during the 3 years of the ABL PT program in Korea, suggesting that ABL PT can be used to keep maintaining traceability.

Keywords : Laboratory proficiency testing, Accuracy-based proficiency testing, Cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol, Triglycerides
꽌濡

吏吏(꼥蘊)寃궗뒗 씠긽吏삁利앹쓽 吏꾨떒, 떖삁愿吏덊솚쓽 쐞뿕룄 삁痢 諛 移섎즺슚怨 異붿쟻뿉 궗슜릺뒗 以묒슂븳 寃궗씠떎. 떖삁愿吏덊솚 쟾 꽭怨꾩쟻쑝濡 궗留앹쓣 쑀諛쒗븯뒗 以묒슂븳 썝씤뱾 以 븯굹씠硫, 젙솗븳 寃궗떎 寃궗寃곌낵뒗 떖삁愿吏덊솚쓽 吏꾨떒 諛 移섎즺諛⑹묠 寃곗젙뿉 븘닔쟻씠떎[1]. 誘멸뎅뿉꽌 뿰援щ맂 옄猷뚯뿉 뵲瑜대㈃, 誘멸뎅吏덈퀝愿由щ낯遺뿉꽌 吏꾪뻾븳 吏吏덇궗 몴以솕 궗뾽쓣 넻빐 留ㅻ뀈 理쒖냼 3뼲3泥8諛깅쭔 떖윭뿉 빐떦븯뒗 寃쎌젣쟻 슚怨(珥 肄쒕젅뒪뀒濡 寃궗 몴以솕濡 씤븳 珥 肄쒕젅뒪뀒濡 愿由 媛쒖꽑 湲곗뿬룄瑜 理쒖냼 0.5%濡 媛젙븯怨, 씠濡 씤븳 湲곕닔紐 뿰옣쓽 媛移섎 5留 遺덈줈 궛젙븿)瑜 嫄곕몢뿀떎怨 븳떎[2]. 뵲씪꽌 吏吏덇궗쓽 젙솗룄瑜 넂씠怨좎옄 븯뒗 끂젰 쟻 鍮꾩슜쑝濡쒕룄 援誘 嫄닿컯 뼢긽뿉 겙 湲곗뿬瑜 븷 닔 엳떎.

븳엫긽寃궗젙룄愿由ы삊쉶뒗 젙솗룄湲곕컲吏吏덇궗뿉 븳 떊鍮숇룄궗뾽 봽濡쒓렇옩(accuracy-based lipids proficiency testing program)쓣 2016뀈遺꽣 떆뻾븯떎. 젙솗룄湲곕컲吏吏덇궗 떊鍮숇룄궗뾽 봽濡쒓렇옩 湲곗쭏슚怨(matrix effect)瑜 理쒖냼솕븯怨 쇅遺젙룄愿由щЪ吏덉쓽 援먰솚꽦(commutability)쓣 쑀吏븯뿬 吏吏덇궗쓽 젙솗룄 룊媛뿉 쟻빀븯떎[3-5]. 誘멸뎅 蹂묐━븰쉶(College of American Pathologists)뿉꽌뒗 2008뀈遺꽣 씠誘 젙솗룄湲곕컲吏吏덇궗瑜 젙솗룄 룊媛瑜 쐞븳 쇅遺젙룄愿由 봽濡쒓렇옩쑝濡 떆뻾븯떎[6]. 엫긽寃궗떎뿉꽌뒗 吏吏덇궗쓽 젙솗룄瑜 쑀吏븯湲 쐞빐 痢≪젙냼湲됱꽦씠 솗蹂대맂 寃궗떆뒪뀥(옣鍮, 移쇰━釉뚮젅씠꽣, 떆빟쓽 議고빀)쓣 궗슜븯怨, 二쇨린쟻쑝濡 寃궗쓽 젙솗룄瑜 寃利앺븷 닔 엳룄濡 젙솗룄湲곕컲 쇅遺젙룄愿由ъ뿉 李몄뿬븷 븘슂媛 엳떎. 겕젅븘떚땶 寃쎌슦뿉 씠誘 吏궃 7뀈媛꾩쓽 젙솗룄湲곕컲 쇅遺젙룄愿由ъ쓽 궗뾽쓣 넻빐 삤李④ 以꾩뼱뱾怨 엳쓬쓣 솗씤븳 諛 엳떎[7].

옄뱾 븳엫긽寃궗젙룄愿由ы삊쉶뿉꽌 二쇨븳 젙솗룄湲곕컲吏吏덇궗 떊鍮숇룄議곗궗궗뾽 옄猷(2016-2018)瑜 遺꾩꽍븯뿬 援궡 엫긽寃궗떎怨 二쇱슂 寃궗떆뒪뀥쓽 吏吏덇궗 젙솗룄 쁽솴쓣 뙆븙븯怨좎옄 븯떎.

옱猷 諛 諛⑸쾿

湲곗쭏 슚怨쇰 理쒖냼솕븯湲 쐞빐 Clinical Laboratory Standard Institute 37A 吏移⑥뿉 뵲씪 1쉶떦 3媛吏 냽룄쓽 援먰솚꽦 깋룞 삁泥(commutable frozen serum, CFS)쓣 吏곸젒 留뚮뱾嫄곕굹 Solomon Park Research Laboratories (Burien, WA, USA)濡쒕꽣 援щℓ븯뿬 궗슜븯떎[8]. 씠瑜 쐞빐 꽭釉뚮뒪蹂묒썝 諛 嫄닿뎅븰援먮퀝썝 엫긽떆뿕떖궗쐞썝쉶쓽 寃넗 諛 뿀씫쓣 諛쏆븯떎(怨쇱젣踰덊샇 4-2016-0328, 4-2017-0351, KUH1200060, KUH1200066). 씠 CFS瑜 媛吏怨 珥 肄쒕젅뒪뀒濡, 怨좊룄吏떒諛(high-density lipoprotein, HDL) 肄쒕젅뒪뀒濡, 諛룄吏떒諛(low-density lipoprotein, LDL) 肄쒕젅뒪뀒濡, 以묒꽦吏諛 벑 젙솗룄湲곕컲吏吏덇궗 떊鍮숇룄議곗궗뿉 궗슜뻽쑝硫, 2016뀈遺꽣 뿰 2쉶뵫 3뀈媛 룊媛븯떎. 2016뀈 1쉶李, 2쉶李 諛 2017뀈 1쉶李 젙룄愿由щЪ吏덉 嫄닿뎅븰援먮퀝썝뿉꽌 젣議고븯怨, 2017뀈 2쉶李⑤뒗 꽭釉뚮뒪蹂묒썝뿉꽌, 2018뀈 1쉶李⑤뒗 Solomon Park Research Laboratories뿉꽌 援щℓ븳 寃껋쓣, 2018뀈 2쉶李⑤뒗 遺꾨떦꽌슱蹂묒썝뿉꽌 젣議고븳 寃껋쓣 궗슜븯떎. 珥 肄쒕젅뒪뀒濡, HDL 肄쒕젅뒪뀒濡, LDL 肄쒕젅뒪뀒濡 諛 以묒꽦吏諛 벑쓽 李멸퀬媛(reference value) 삉뒗 紐⑺몴媛(target value) 李멸퀬痢≪젙諛⑸쾿쓣 궗슜븯뒗 李멸퀬痢≪젙寃궗떎濡쒖꽌 Table 1怨 媛숈씠 媛 醫낅ぉ蹂꾨줈 援젣쟻쑝濡 씤젙諛쏅뒗 寃궗떎뿉 쓽猶고븯떎. 利 珥 肄쒕젅뒪뀒濡, HDL 肄쒕젅뒪뀒濡, LDL 肄쒕젅뒪뀒濡ㅼ쓽 寃쎌슦뿉뒗 誘멸뎅 吏덈퀝愿由щ낯遺뿉 蹂몃瑜 몦 肄쒕젅뒪뀒濡 몴以寃궗 꽕듃썙겕寃궗떎(Cholesterol Reference Measurement Laboratory Network, CRMLN)씤 罹먮굹굹 CEQAL 삉뒗 誘멸뎅 Northwest Lipid Metabolism and Diabetes Research Laboratories뿉 쓽猶고븯뿬 誘멸뎅 Centers for Disease Control and Prevention 몴以寃궗踰뺤씤 Abell Kendall踰 諛 踰좏젙웾踰(beta-quantification踰)쑝濡 痢≪젙븯떎[9]. 以묒꽦吏諛 諛 쑀由ш由ъ꽭濡ㅼ쓽 寃쎌슦뿉뒗 씪蹂몄쓽 궗떒踰뺤씤 寃궗쓽븰몴以臾쇱쭏湲곌뎄(Reference Material Institute for Clinical Chemistry Standards) CRMLN 씤利앹쓣 諛쏆 슦由щ굹씪 吏덈퀝愿由щ낯遺 留뚯꽦吏덊솚삁諛⑷낵 援媛吏꾨떒쓽븰몴以寃궗떎(National Medical Reference Laboratory), 삉뒗 떛媛룷瑜댁쓽 Health Sciences Authority 몴以寃궗떎뿉 쓽猶고븯떎. 以묒꽦吏諛 以묒뿉 湲由ъ꽭濡 냼嫄곕쾿(glycerol blanking)쓽 李멸퀬媛믪 珥 湲由ъ꽭씪씠뱶(total glyceride)뿉꽌 쑀由 湲由ъ꽭濡ㅼ쓣 類 媛믪쑝濡 븯怨, 湲由ъ꽭濡 鍮꾩냼嫄곕쾿(glycerol non-blanking)쓽 李멸퀬媛믪 珥 湲由ъ꽭씪씠뱶 媛믪쑝濡 븯떎. 媛 李멸湲곌쓽 醫낅ぉ蹂 뿀슜湲곗 Table 1뿉 엳뒗 濡 National Cholesterol Education Program (NCEP) 珥 삤李④린以쑝濡 룊媛븯떎. Apolipoprotein A1, apolipoprotein B, lipoprotein (a) 醫낅ぉ 븘吏 슌졆븳 李멸퀬痢≪젙諛⑸쾿 쓽猶곌 뼱젮썙꽌 李멸湲곌뱾쓽 빀쓽 룊洹(consensus mean)쓣 李멸퀬媛믪쑝濡 븯떎. 삉븳 媛 醫낅ぉ蹂 뿀슜踰붿쐞뒗 Table 1怨 媛숈씠 젙븯떎[10]. 떒, 빀쓽 룊洹 諛 몴以렪李 궛젙 李멸湲곌쓽 궗遺꾩쐞媛꾨쾾쐞(interquartile range, IQR)쓽 1.5諛곕 珥덇낵븯뿬 Q1蹂대떎 궙嫄곕굹 IQR쓽 1.5諛곕 珥덇낵븯뿬 Q3蹂대떎 넂 寃곌낵媛믪쓣 踰쀬뼱궃 寃껋쓣 씠긽젏(outlier)쑝濡 媛꾩<븯뿬 젣嫄고븳 썑뿉 궛젙븯떎.

Table 1 . List of reference-measurement laboratories and acceptable limits of accuracy-based lipid assays.

긖est itemReference measurement laboratoriesAcceptable limitsNCEP performance criteria for inaccuracy [10]
Total cholesterolCEQAL*, NWRL짹9%짹3%
High-density lipoprotein cholesterolCEQAL, NWRL짹13%짹5%
Low-density lipoprotein cholesterolCEQAL, NWRL짹12%짹4%
Total glyceridesReCCS, NMRL짹15%짹5%
Free glycerolReCCS, HSA짹15%짹5%
Apolipoprotein A1-짹15%-
Apolipoprotein B-짹15%-
Lipoprotein (a)-짹3 SD-

Acceptable limits based on the NCEP performance criteria [10]..

Abbreviations: NCEP, National Cholesterol Education Program; SD, standard deviation..

*CEQAL (Canada, https://www.ceqal.com/).

Northwest Lipid Metabolism and Diabetes Research Laboratories (https://endocrinology.uw.edu/research/institutes).

Reference Material Institute for Clinical Chemistry Standards (Japan, http://www.reccs.or.jp/en/).

National Medical Reference Laboratory (Korea, from the second round of 2017; http://www.cdc.go.kr/CDC/eng/).

Health Sciences Authority, Singapore.

Consensus (average of each test of all participants excluding outlier).


寃곌낵

젙솗룄湲곕컲吏吏덇궗뿉 李멸븯뒗 湲곌 닔뒗 泥 빐뿉 164湲곌쑝濡 2016뀈룄 씪諛섑솕븰寃궗 봽濡쒓렇옩 珥 肄쒕젅뒪뀒濡 李멸湲곌 닔 1,366媛 湲곌쓽 12%뿉 遺덇낵븯쑝굹 3뀈吏몄씤 2018뀈룄뿉뒗 223湲곌씠 李몄뿬븯뿬 빟 15%濡 利앷븯떎[11,12]. 李멸湲곌 닔쓽 利앷뒗 Table 2 媛숈븯떎. 3뀈媛 NCEP 삤李⑦뿀슜踰붿쐞 湲곗쑝濡 蹂 븣뿉 珥 肄쒕젅뒪뀒濡, HDL 肄쒕젅뒪뀒濡, 珥 湲由ъ꽭由щ뱶(湲由ъ꽭濡 鍮꾩냼嫄곕쾿)쓽 李멸湲곌 룊洹좎삤李⑤뒗 1-2쉶留 NCEP 뿀슜삤李⑤ 踰쀬뼱궃 뜲 鍮꾪빐 以묒꽦吏諛(湲由ъ꽭濡 냼嫄곕쾿), 듅엳 LDL 肄쒕젅뒪뀒濡ㅼ 뜑 뿬윭 李⑤ NCEP 뿀슜삤李⑤ 踰쀬뼱궗떎(Tables 3, 4). 李멸湲곌 以묒뿉 10媛 씠긽쓽 湲곌씠 궗슜븳 珥 肄쒕젅뒪뀒濡, HDL 肄쒕젅뒪뀒濡, LDL 肄쒕젅뒪뀒濡, 珥 湲由ъ꽭由щ뱶, 以묒꽦吏諛 떆빟쓽 젣議곗궗蹂 삤李⑥쓽 3媛쒕뀈 룞븞쓽 異붿씠뒗 Fig. 1遺꽣 Fig. 5뿉 湲곗닠븯떎. CAL-17-03 寃泥댁쓽 寃쎌슦뿉 以묒꽦吏諛⑹씠 277 mg/dL濡 넂 寃泥댁뒗뜲, LDL 肄쒕젅뒪뀒濡ㅼ쓽 삤李④린以쓣 꽆뼱꽌뒗 湲곌씠 留롮븘 룊媛뿉꽌 젣쇅븯떎. Apolipoprotein A1, apolipoprotein B, 諛 lipoprotein (a)쓽 寃쎌슦뿉뒗 李멸퀬諛⑸쾿쑝濡 李멸퀬媛믪쓣 援ы븯湲 옒뱾뼱 빀쓽 룊洹좎쓣 湲곗큹濡 媛 湲곌쓽 삤李⑥ 룊洹좎삤李⑤ 援ы븯怨 3媛쒕뀈媛꾩쓽 洹 異붿씠뒗 Supplementary Figs.1-4 源뚯 湲곗닠븯떎. 븳렪, 媛 湲곌蹂꾨줈 Table 1뿉 湲곗닠븳 삤李⑦뿀슜踰붿쐞 궡뿉 뱾뼱媛뒗 湲곌쓽 鍮꾩쑉쓽 異붿씠뒗 Fig. 6뿉 湲곗닠븯뒗뜲, 珥 肄쒕젅뒪뀒濡 諛 以묒꽦吏諛(湲由ъ꽭濡 鍮꾩냼嫄곕쾿)쓽 寃쎌슦뿉뒗 뿀슜踰붿쐞 궡뿉 遺遺꾩쓽 湲곌씠 뱾뿀쑝굹, HDL 肄쒕젅뒪뀒濡ㅼ 뿀슜踰붿쐞瑜 踰쀬뼱굹뒗 湲곌룄 苑 엳뿀怨, 듅엳 LDL 肄쒕젅뒪뀒濡ㅼ쓽 寃쎌슦뿉뒗 뿀슜踰붿쐞 씠궡쓽 媛믪쓣 蹂닿퀬븳 湲곌씠 빟 90% 궡쇅瑜 쑀吏븯떎媛 留덉留 쉶李⑥뿉 뿀슜踰붿쐞 궡뿉 뱾뼱媛뒗 湲곌씠 98%濡 넂븘議뚮떎.

Table 2 . Number of participating laboratories for accuracy-based lipids programs of the Korean Association of External Quality Assessment Service from 2016 to 2018.

긘ariableYear-roundIncrease (%)*

2016-1st2016-2nd2017-1st2017-2nd2018-1st2018-2nd
Total cholesterol16416516918521922336.0
High-density lipoprotein cholesterol16316416818421922336.8
Low-density lipoprotein cholesterol15815916417821021435.4
Triglycerides15916316718421722139.0
Total glycerides (glycerol non-blanking)9810110811813413941.8
Triglycerides (glycerol blanking)61625966838234.4
Apolipoprotein A167707777797714.9
Apolipoprotein B79839394999824.1
Lipoprotein (a)59596565686713.6

*Percent increase in the number of participating laboratories for each item from 2016 to 2018.

The number of participating laboratories for triglycerides, including total glycerides (glycerol non-blanking) and triglycerides (glycerol blanking).


Table 3 . Average percent bias change of participants of the accuracy-based lipids external quality assurance program based on the Korea External Quality Assessment Scheme from 2016 to 2018 for total cholesterol, direct HDL cholesterol, and direct LDL cholesterol.

Year-roundPoolTotal cholesterolHDL cholesterolLDL cholesterol



Target valueAverage of all participantsAverage bias (%)Target valueAverage of all participantsAverage bias (%)Target valueAverage of all participantsAverage bias (%)
2016-1stCAL-16-01189.1189.60.2649.648.9-1.41111.8119.97.25
2016-1stCAL-16-02175.6175.80.1161.962.71.2997.599.21.74
2016-1stCAL-16-03227227.60.264747.20.43146.2153.75.13
2016-2ndCAL-16-04212.5213.90.6658.9590.17134.9137.62.00
2016-2ndCAL-16-05191.5191.60.054948.9-0.20121.1123.51.98
2016-2ndCAL-16-06152.41530.3938.336.2-5.4885.292.48.45
2017-1stCAL-17-01185.3186.20.4970.770.4-0.4298.8100.41.62
2017-1stCAL-17-02164.6164.4-0.1255.355.80.9088.592.74.75
2017-1stCAL-17-03178.6184.53.304342.8-0.4787.299.113.65
2017-2ndCAL-17-04184.3185.30.5450.749.2-2.96102.2107.55.19
2017-2ndCAL-17-05211.6213.20.765251.6-0.77129.7133.22.70
2017-2ndCAL-17-06229.3230.60.5743.243.20.00147.1154.65.10
2018-1stCAL-18-016160.4-0.982322.9-0.4332.530.4-6.46
2018-1stCAL-18-02226222.8-1.425453.4-1.11130134.63.54
2018-1stCAL-18-03160157.9-1.314242.71.679997-2.02
2018-2ndCAL-18-04140.8139.8-0.7141.240.4-1.9483.183.10.00
2018-2ndCAL-18-05201.4200.8-0.3056.255.7-0.89118.6120.21.35
2018-2ndCAL-18-06241.2240.9-0.1264.565.71.86164.7158.4-3.83
Average0.14-0.542.90

NCEP inaccuracy performance criteria for total cholesterol, HDL cholesterol, and LDL cholesterol are 짹3%, 짹5%, and 짹4%, respectively [10]. Bold type signifies all cells which exceeded NCEP inaccuracy performance criteria for each test item..

Abbreviations: HDL, high-density lipoprotein; LDL, low-density lipoprotein; NCEP, National Cholesterol Education Program..


Table 4 . Average percent bias change of participants of the accuracy-based lipids external quality assurance program based in Korea External Quality Assessment Scheme from 2016 to 2018 for total glycerides (glycerol non-blanking) and triglycerides (glycerol blanking) assay.

Year-roundPoolTotal glycerides (glycerol non-blanking)Triglycerides (glycerol blanking)


Target valueAverage of all participantsAverage bias (%)Target valueAverage of all participantsAverage bias (%)
2016-1stCAL-16-01134.5130.4-3.05127.6127.4-0.16
2016-1stCAL-16-026965-5.8061.757.9-6.16
2016-1stCAL-16-03145.4144.4-0.69139.1141.61.80
2016-2ndCAL-16-0484.683.7-1.0672.670.4-3.03
2016-2ndCAL-16-05100.197-3.1091.387.7-3.94
2016-2ndCAL-16-06154.8158.92.65143.9150.14.31
2017-1stCAL-17-0176.674.9-2.2267.363.7-5.35
2017-1stCAL-17-0286.284.8-1.6276.974.8-2.73
2017-1stCAL-17-03277.1279.10.72260.7265.91.99
2017-2ndCAL-17-04180.9182.20.72174.5177.71.83
2017-2ndCAL-17-05149.8150.90.73145.3148.62.27
2017-2ndCAL-17-06178.9181.51.45172.9177.72.78
2018-1stCAL-18-0135.0534.4-1.8532.528.4-12.62
2018-1stCAL-18-02178.81178.5-0.17130134.63.54
2018-1stCAL-18-0398.9298.7-0.229997-2.02
2018-2ndCAL-18-0492.991.7-1.2986.486-0.46
2018-2ndCAL-18-05137.8139.10.94129.5132.82.55
2018-2ndCAL-18-0663.660.1-5.5054.850.2-8.39
Average-1.08-1.32

NCEP inaccuracy performance criteria for triglycerides was 짹5% [10]. Bold type signifies all cells which exceeded NCEP inaccuracy performance criteria for each test item..

Abbreviation: NCEP, National Cholesterol Education Program..


Figure 1.

Average percent bias change for total cholesterol of each manufacturer in the accuracy-based lipids EQA program (20162018). Abbreviation: EQA, external quality assessment. The instruments were from the following companies: Roche Diagnostics (Mannheim, Germany); Beckman Coulter Inc. (Brea, CA, USA); Sekisui Medical Co. Ltd. (Tokyo, Japan); Siemens Healthcare Diagnostics Inc. (Erlangen, Germany); Kyowa Medex Co. Ltd. (Tokyo, Japan); and Fujifilm Wako Pure Chemical Corp. (Osaka, Japan).


Figure 2.

Average percent bias change in the direct HDL cholesterol assay of each manufacturer in the accuracy-based lipid EQA program (20162018). Abbreviations: HDL, high-density lipoprotein; EQA, external quality assessment. The instruments were from the following companies: Roche Diagnostics (Mannheim, Germany); Beckman Coulter Inc. (Brea, CA, USA); Sekisui Medical Co. Ltd. (Tokyo, Japan); Kyowa Medex Co. Ltd. (Tokyo, Japan); and Siemens Healthcare Diagnostics Inc. (Erlangen, Germany).


Figure 3.

Average percent bias change in the direct LDL cholesterol assay of each manufacturer in the accuracy-based lipid EQA program (20162018). We excluded the CAL-17-03 pool, as it may not be suitable for the evaluation of LDL cholesterol in the external quality assurance program. Abbreviations: LDL, low-density lipoprotein; EQA, external quality assessment. The instruments were from the following companies: Roche Diagnostics (Mannheim, Germany); Beckman Coulter Inc. (Brea, CA, USA); Sekisui Medical Co. Ltd. (Tokyo, Japan); Kyowa Medex Co. Ltd. (Tokyo, Japan); and Siemens Healthcare Diagnostics Inc. (Erlangen, Germany).


Figure 4.

Average percent bias change in the total glycerides (glycerol non-blanking) assay of each manufacturer in the accuracy-based lipids EQA program (20162018). Abbreviation: EQA, external quality assessment. The instruments were from the fol-lowing companies: Roche Diagnostics (Mannheim, Germany); Beckman Coulter Inc. (Brea, CA, USA); and Siemens Healthcare Diagnostics Inc. (Erlangen, Germany).


Figure 5.

Average percent bias change in the triglycerides (glycerol blanking) assay of each manufacturer in the accuracy-based lipids EQA program (20162018). Abbreviation: EQA, external quality assessment. The instruments were from the following companies: Sekisui Medical Co. Ltd. (Tokyo, Japan); Kyowa Medex Co. Ltd. (Tokyo, Japan); and Fujifilm Wako Pure Chemical Corp. (Osaka, Japan).


Figure 6.

Change in the proportion of participating laboratories with an acceptable performance in each test in the accuracy-based lipids proficiency testing from 2016 to 2018 in the Korean External Quality Assurance Scheme. We excluded the CAL-17-03 pool among three pools of the 2017-01 round, as it may not be suitable for the evaluation of LDL cholesterol performance in the external quality assurance program. Ab-breviations: HDL, high-density lipoprotein; LDL, low-density lipoprotein.


怨좎같

븳엫긽寃궗젙룄愿由ы삊쉶뒗 삁泥쓽 湲곗쭏슚怨(matrix effect)瑜 理쒖냼솕븯怨 援먰솚꽦(commutability)쓣 쑀吏븯湲 쐞븯뿬 2016뀈룄遺꽣 젙솗룄湲곕컲吏吏덇궗 떊鍮숇룄궗뾽 봽濡쒓렇옩쓣 떆옉븯떎. 留ㅻ뀈 李멸湲곌씠 利앷븯뿬 3李⑥뿰룄 李몄뿬湲곌 1李⑥뿰룄 李몄뿬湲곌뿉 鍮꾪빐 13.6%-41.8% 利앷븯떎. 븳렪, 3李⑥뿰룄뿉뒗 珥 肄쒕젅뒪뀒濡, HDL 肄쒕젅뒪뀒濡, LDL 肄쒕젅뒪뀒濡, 以묒꽦吏諛(湲由ъ꽭濡 鍮꾩냼嫄곕쾿 諛 湲由ъ꽭濡 냼嫄곕쾿) 紐⑤몢뿉꽌 李멸湲곌뱾쓽 룊洹 %삤李⑤뒗 遺遺 NCEP 寃궗蹂 닔뻾 젙솗룄 湲곗踰붿쐞 궡뿉 뱾뼱 솕쑝굹, 3뀈媛 뿰 2쉶 媛 쉶李⑤쭏떎 3媛吏 냽룄쓽 珥 18媛쒖쓽 CFS 寃泥대 醫낇빀쟻쑝濡 룊媛븯쓣 븣, 珥 肄쒕젅뒪뀒濡 諛 HDL 肄쒕젅뒪뀒濡ㅼ 媛 1쉶, LDL 肄쒕젅뒪뀒濡ㅼ 8쉶, 以묒꽦吏諛(湲由ъ꽭濡 鍮꾩냼嫄곕쾿) 2쉶, 以묒꽦吏諛(湲由ъ꽭濡 냼嫄곕쾿) 4쉶뿉꽌 NCEP 뿀슜湲곗쓣 踰쀬뼱궗떎. 븳렪, 珥 肄쒕젅뒪뀒濡ㅼ쓽 寃쎌슦뿉 젣議곗궗 媛꾩쓽 젙솗룄뿉 빟媛꾩쓽 李⑥씠媛 엳뿀뒗뜲 Roche궗(Roche Diagnostics, Mannheim, Germany)쓽 寃쎌슦뿉 1%-2%쓽 쓬꽦삤李⑤ 蹂댁씠뒗뜲, 씠뒗 떆빟 諛 移쇰━釉뚮젅씠꽣 젣議 떆 李멸퀬諛⑸쾿쓣 isotope dilution gas chromatography-mass spectrometry (ID-GC-MS)踰뺤쓣 湲곗쑝濡 븯湲 븣臾몄쑝濡 蹂댁씤떎(Fig. 1). 븳엫긽寃궗젙룄愿由ы삊쉶 봽濡쒓렇옩뿉꽌뒗 鍮꾨줉 ID-GC-MS踰뺤뿉 鍮꾪빐 鍮꾪듅씠쟻씤 뼇꽦삤李⑤ 蹂댁씠吏留, 誘멸뎅, 씪蹂 벑吏뿉꽌 留롮씠 벐씠뒗 Abell Kendall踰뺤쓣 李멸퀬寃궗踰뺤쑝濡 궗슜븯떎. 븘吏 誘멸뎅, 씪蹂 벑뿉꽌뒗 Abell Kendall踰뺤쓽 젙솗룄 臾몄젣瑜 씤吏븯怨 엳쓬뿉룄 遺덇뎄븯怨 怨쇨굅遺꽣 뿭븰뿰援ъ뿉꽌 留롮씠 궗슜릺뿀뜕 Abell Kendall踰뺤쓣 李멸퀬諛⑸쾿쑝濡 怨좎닔븯怨 엳뒗 떎젙씠떎. HDL 肄쒕젅뒪뀒濡ㅼ쓽 寃쎌슦뿉 Sekisui궗(Sekisui Medical Co. Ltd., Tokyo, Japan)뒗 뼇꽦삤李⑤, Beckman Coulter궗(Beckman Coulter Inc., Brea, CA, USA)뒗 쓬꽦삤李⑤ 蹂댁씠뒗 寃쏀뼢씠 엳뿀떎(Fig. 2). LDL 肄쒕젅뒪뀒濡ㅼ쓽 寃쎌슦뿉뒗 쟾泥댁쟻쑝濡 뼇꽦삤李⑤ 蹂댁씠뒗 寃쏀뼢씠 엳뿀怨 듅엳 Siemens 젣뭹(Siemens Healthcare Diagnostics Inc., Erlangen, Germany)쓽 뼇꽦삤李④ 而몃떎(Fig. 3). 洹몃윭굹 LDL 肄쒕젅뒪뀒濡ㅼ쓽 寃쎌슦뿉 깋룞 삁泥쓣 궗슜븯뒗 寃쎌슦뿉 젙솗룄 룊媛뿉 臾몄젣媛 엳怨 떊꽑 삁泥씠굹 삁옣쓣 鍮꾧탳룊媛뿉 異붿쿇븯湲 븣臾몄뿉 寃곕줎쓣 궡由ш린 옒뱺 빆紐⑹씠씪 븯寃좊떎[13]. 듅엳 CAL-17-03 寃泥댁쓽 寃쎌슦뿉 以묒꽦吏諛⑹씠 277 mg/dL濡 넂怨 媛 湲곌蹂 LDL 삤李⑤쾾쐞瑜 踰쀬뼱궃 湲곌씠 留ㅼ슦 留롮씠 諛쒖깮븯湲곗뿉, 쇅遺젙룄愿由щЪ吏덈줈뒗 遺쟻빀떎怨 뙋젙븯뿬 룊媛뿉 궗슜븯吏 븡븯떎. 씠 寃泥대 LDL 븘삎遺꾩꽍쓣 빐 蹂대땲 珥덉諛룄吏떒諛(very low-density lipoprotein, VLDL)씠 22.2%씠뿀怨 VLDL 鍮꾩쑉씠 넂쓣닔濡 LDL 肄쒕젅뒪뀒濡 吏곸젒踰뺤쓽 룊洹좎삤李⑤ 利앷떆궎뒗 寃껋쑝濡 異붿젙릺뿀떎. 洹몃윭굹 VLDL 삤엳젮 LDL 肄쒕젅뒪뀒濡ㅼ쓽 쓬꽦삤李⑤ 씪쑝궓떎뒗 臾명뿄怨쇰뒗 꽌濡 諛곗튂릺뒗 寃곌낵濡쒖꽌, 痢≪젙뿉 궗슜릺뒗 떆빟뿉 뵲씪 媛꾩꽠쓣 씪쑝궎뒗 湲곗쟾씠 떖씪吏 닔 엳쓣 寃껋쑝濡 異붿젙릺硫 異붽뿰援ш 븘슂븷 寃껋쑝濡 깮媛곷릺뿀떎[14]. 以묒꽦吏諛⑹쓽 寃쎌슦뿉뒗 遺遺 媛닔遺꾪빐븯뿬 湲由ъ꽭濡ㅼ쓣 痢≪젙븯뒗 諛⑸쾿씠 留롮씠 궗슜릺怨 엳떎. 洹몃윭굹 삁븸뿉뒗 쑀由 湲由ъ꽭濡ㅼ씠 빟 5% 젙룄 냼웾 議댁옱븯硫 寃쎌슦뿉 뵲씪 湲由ъ꽭濡ㅼ쓣 빟젣濡 궗슜븯뒗 寃쎌슦뿉뒗 洹 뼇씠 留롮쓣 닔 엳뼱 湲由ъ꽭濡 냼嫄곕쾿(glycerol blanking)씠 젙솗븳 諛⑸쾿씠씪 븷 닔 엳怨 씪蹂몄뿉꽌뒗 遺遺꾩쓽 엫긽寃궗떎뿉꽌 씠 諛⑸쾿쓣 궗슜븯吏留 쟾 꽭怨꾩쟻쑝濡쒕뒗 湲由ъ꽭濡 鍮꾩냼嫄곕쾿(glycerol non-blaking)쓣 뜑 留롮씠 궗슜븳떎[15,16]. 슦由щ굹씪뿉꽌뒗 湲由ъ꽭濡 냼嫄곕쾿쓣 궗슜븯뒗 湲곌씠 李몄뿬湲곌 以묒뿉 35%-38% 젙룄瑜 李⑥븯떎(Table 2). 씠젃寃 몢 媛吏 諛⑸쾿씠 궗슜릺떎 蹂대땲 쟾援쟻씤 뿰援щ굹 鍮 뜲씠꽣 뿰援ъ뿉 샎룞쓣 씪쑝궎뒗 臾몄젣媛 엳떎. 삉븳 쇅遺젙룄愿由ъ궗뾽쓣 븯뒗 엯옣뿉꽌 媛 李몄뿬湲곌씠 湲由ъ꽭濡 냼嫄곕쾿쓣 벐뒗吏 鍮꾩냼嫄곕쾿쓣 벐뒗吏 紐낇솗븳 솗씤씠 븘슂븯떎. 洹몃━怨 蹂 봽濡쒓렇옩怨 媛숈씠 젙솗룄湲곕컲吏吏덇궗쓽 寃쎌슦뿉 珥 湲由ъ꽭由щ뱶(total glycerides)肉먮쭔 븘땲씪 쑀由 湲由ъ꽭濡ㅼ쓣 李멸퀬諛⑸쾿쓣 씠슜븯뿬 蹂꾨룄濡 痢≪젙빐빞 븯뒗 臾몄젣媛 諛쒖깮븳떎[17-19]. 븳렪, apolipoprotein A1, apolipoprotein B, lipoprotein (a) 媛숈 븘룷떒諛깆 쁽옱 李멸퀬諛⑸쾿쓣 媛쒕컻븯뒗 떒怨꾩씠怨 李멸퀬寃궗떎 쓽猶곌 뼱젮슫 硫댁씠 엳뼱 빀쓽 룊洹좎쓣 湲곗쑝濡 젙솗룄瑜 룊媛븯떎[20,21] (Supplementary Figs. 1-3).

寃곕줎쟻쑝濡, 씠 젙솗룄湲곕컲吏吏덇궗뒗 湲곗쭏슚怨쇰 理쒖냼솕븯뿬 援먰솚꽦씠 엳뒗 깋룞삁泥쓣 궗슜븯뿬 슦由щ굹씪 엫긽寃궗떎쓽 吏吏덇궗쓽 젙솗룄瑜 룊媛븯怨 엳쑝硫, 젣議곗궗蹂꾨줈 넻怨꾨 궡뼱 젙솗룄 뼢긽뿉 湲곗뿬븯怨 엳떎怨 깮媛곹븳떎.

Supplementary
媛먯궗쓽 湲

옄뱾 씠 젙솗룄湲곕컲吏吏덇궗 궗뾽怨 蹂닿퀬꽌 옉꽦源뚯 留롮 룄쓣 二쇱떊 異⑸궓븰援 쓽怨쇰븰 吏꾨떒寃궗쓽븰援먯떎 沅뚭퀎泥 援먯닔떂, 엫吏꾩닕 援먯닔떂怨 嫄닿뎅븰援먮퀝썝 源븯굹 援먯닔떂, 洹몃━怨 吏덈퀝愿由щ낯遺 議곗갔씡 꽑깮떂 벑 뿬윭遺꾨뱾猿 媛먯궗瑜 뱶由곕떎.

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