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Analyses of the Proficiency Testing Program and the Performance of Qualitative Reagents for Rheumatoid Factor
J Lab Med Qual Assur 2019;41:105-110
Published online June 30, 2019
© 2019 Korean Association of External Quality Assessment Service.

Jongwon Oh and Hyung-Doo Park

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence to: Hyung-Doo Park, Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea, Tel: +82-2-3410-0290 Fax: +82-2-3410-2719 E-mail: nayadoo@hanmail.net
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

Background:

Rheumatoid factor (RF) is used as one of the diagnostic criteria for rheumatoid arthritis. The purpose of this study was to evaluate qualitative RF reagents used in clinical laboratories in Korea, and to provide basic data that can be used as a reference to improve the quality of RF testing.

Methods:

We reviewed the proficiency testing results for RF from the Korean Association of External Quality Assessment Service (KEQAS) and College of American Pathologists. Moreover, we evaluated five commercially available RF qualitative reagents, including LabSlide RF (IVD Lab Co., Korea), ASAN RA Latex Reagents (Asan Pharmaceuticals Co., Korea), RaPET RF (Stanbio Laboratory, USA), RF Latex Test (Pulse Scientific Inc., Canada), and RF-100 (Teco Diagnostics, USA). Commercially available quality control materials, calibrators, and pooled sera were used in this study. The consistency of qualitative reagents and Kappa statistics were calculated based on the quantitative values of the quality control materials and the mixed sera.

Results:

Up to 51.5% of high concentration samples were reported as negative in KEQAS. RF qualitative reagent test results were not consistent among reagent types. The consistency of the qualitative and quantitative test results was between 51% and 100%, and the kappa statistics varied depending on the reagent manufacturer.

Conclusions:

Measurement of RF qualitative reagents used in domestic clinical laboratories was not consistent with the quantitative values, and hence it is necessary to improve the consistency and verify the adequacy of the cut-off value.

Keywords : Rheumatoid factor, Rheumatoid arthritis, Proficiency testing, Quality control
꽌濡

瑜섎쭏떚뒪 愿젅뿼 몴쟻씤 옄媛硫댁뿭吏덊솚쑝濡 씪諛섏쟻쑝濡 씤援ъ쓽 1%뿉꽌 諛쒖깮븯硫, 뿬꽦뿉寃 샇諛쒗븯뒗 留뚯꽦吏꾪뻾꽦 뿼利앹쭏솚씠떎. 瑜섎쭏떚뒪 愿젅뿼 몴以솕맂 寃궗踰뺤씠 뾾湲 븣臾몄뿉 엫긽利앹긽, 떊泥닿궗, 吏꾨떒寃궗 냼寃, 쁺긽寃궗 냼寃 벑쓣 醫낇빀븯뿬 吏꾨떒븯寃 맂떎. 1987뀈뿉 媛쒖젙맂 誘멸뎅 瑜섎쭏떚뒪븰쉶쓽 瑜섎쭏떚뒪 愿젅뿼 吏꾨떒湲곗뿉 쓽븯뿬 씪怨 媛吏 빆紐 以 꽕 媛吏 씠긽쓣 異⑹”떆궎硫 瑜섎쭏떚뒪 愿젅뿼쑝濡 吏꾨떒븯怨, 洹 以 吏꾨떒寃궗 냼寃ъ쑝濡쒕뒗 삁泥 瑜섎쭏떚뒪씤옄(rheumatoid factor, RF) 뼇꽦留 룷븿릺뼱 엳뿀떎[1]. 씠썑 2010뀈뿉 誘멸뎅 瑜섎쭏 떚뒪븰쉶 쑀읇 瑜섎쭏떚뒪븰쉶쓽 怨듬룞뿰援ъ뿉 쓽빐 깉濡쒖슫 遺꾨쪟湲곗씠 諛쒗몴릺뿀쑝硫, 떦떆 湲곗뿉 삁泥 RF 빆 cyclic citrullinated peptide 빆泥닿궗媛 룷븿릺뿀떎[2]. 뵲씪꽌 RF뒗 瑜섎쭏떚뒪吏덊솚씠 쓽떖릺뒗 솚옄뱾뿉寃 븘닔쟻씤 寃궗濡 엫긽寃궗떎뿉꽌 留롮씠 떆뻾릺怨 엳떎.

RF뒗 硫댁뿭湲濡쒕텋由 immunoglobulin G (IgG)쓽 Fc portion 뿉 寃고빀븯뒗 옄媛빆泥댁씠硫, 瑜섎쭏떚뒪 愿젅뿼 솚옄쓽 60%-80% 뿉꽌 뼇꽦씤 寃껋쑝濡 븣젮졇 엳떎. RF쓽 寃궗諛⑸쾿 1956뀈 씪뀓뒪쓳吏묐쾿뿉 쓽븳 젙꽦寃궗踰뺤씠 泥섏쓬쑝濡 媛쒕컻릺뿀쑝硫, 씠썑 슚냼寃고빀硫댁뿭痢≪젙踰(enzyme-linked immunosorbent assay), 諛⑹궗硫댁뿭痢≪젙踰(radioimmunoassay), 硫댁뿭샎긽痢≪젙踰(Immunoturbidimetric assay) 벑씠 媛쒕컻릺뼱 젙웾寃궗媛 媛뒫븯寃 릺뿀떎[3]. RF뒗 瑜섎쭏떚뒪 愿젅뿼쓽 諛쒕퀝뿉 븳 以묒슂븳 삁痢≪씤옄씤뜲, 젙웾寃궗踰뺤 젙웾媛믪쓣 異붿쟻 愿李고븯硫댁꽌 瑜섎쭏떚뒪 愿젅뿼 솚옄쓽 吏덈퀝 吏꾪뻾뼇긽 벑쓣 룊媛븷 닔 엳怨 옄룞솕맂 寃궗옣鍮꾨 씠슜븯뿬 슜웾 寃泥 泥섎━媛 媛뒫븯떎뒗 옣젏씠 엳떎. 씠뿉 鍮꾪빐 젙꽦寃궗踰뺤 슜웾 寃泥 泥섎━ 諛 寃곌낵 빐꽍뿉 뼱젮씠 엳吏留, 寃궗 닔뻾쓽 媛꾪렪븿怨 媛믪떬 媛寃 寃쎌웳젰 벑쓽 옣젏쑝濡 씤븯뿬 嫄닿컯寃吏꾩씠굹 꽑蹂꾧궗 슜룄濡 뿬쟾엳 留롮 엫긽寃궗떎뿉꽌 궗슜릺怨 엳떎. 洹몃윭굹 씪뀓뒪쓳 吏묐쾿쓣 씠슜븳 젙꽦寃궗쓽 듅꽦 븣臾몄뿉 뙋룆옄뿉 뵲씪 寃곌낵媛 떎瑜닿쾶 뙋룆맆 媛뒫꽦씠 엳怨, 긽슜솕맂 RF 寃궗떆빟 媛 뙋룆 寃곌낵쓽 遺덉씪移섍 愿李곕맂 諛 엳뼱, 뼇꽦, 쓬꽦 뙋젙뿉 엳뼱꽌룄 李⑥씠媛 엳쓣 닔 엳떎怨 蹂닿퀬릺뿀떎[3,4].

RF 寃궗뿉 궗슜릺뒗 떆빟 떎뼇븳뜲, 寃궗諛⑸쾿 삉뒗 떆빟뿉 뵲씪 RF 寃궗寃곌낵媛 떖씪吏뒗 寃껋씠 蹂닿퀬맂 諛 엳떎[3,4]. 삉븳 RF쓽 젙꽦寃궗 媛 긽愿꽦 諛 젙웾寃궗 媛 긽愿꽦뿉 鍮꾪븯뿬 젙꽦寃궗 젙웾寃궗 媛꾩쓽 긽愿꽦씠 궙 寃껋쑝濡 蹂닿퀬릺뿀떎[5]. RF 寃궗寃곌낵뒗 瑜섎쭏떚뒪 愿젅뿼쓽 吏꾨떒 諛 移섎즺 寃곗젙 뿉 以묒슂븳 뿭븷쓣 븯誘濡 꽌濡 떎瑜 RF 寃궗떆빟쓽 쑀슜꽦쓣 룊媛븯뒗 寃껋 以묒슂븯떎[6]. 洹몃윭굹 븳엫긽寃궗젙룄愿由ы삊 쉶뿉꽌 닔뻾 以묒씤 떊鍮숇룄議곗궗 떒諛깅㈃뿭봽濡쒓렇옩쓣 궡렣蹂대㈃ RF 빆紐⑹쓽 젙꽦 諛 젙웾寃궗뿉 룞씪븳 젙룄愿由щЪ吏덉쓣 궗슜 븯쓬뿉룄 遺덇뎄븯怨, 젙웾寃궗 寃곌낵 젙꽦寃궗 寃곌낵媛 遺덉씪 移섑븳 寃쎌슦媛 긽떦닔 諛쒖깮븯떎[7]. 蹂 뿰援ъ뿉꽌뒗 吏궃 떊鍮숇룄議곗궗봽濡쒓렇옩쓽 RF 寃궗빆紐 寃곌낵瑜 遺꾩꽍븯怨, 援궡 엫긽 寃궗떎뿉꽌 궗슜릺뒗 RF 젙꽦寃궗쓽 寃곌낵 젙웾寃궗쓽 寃곌낵瑜 鍮꾧탳 룊媛븯뿬 RF 寃궗쓽 吏 뼢긽쓣 쐞븳 李멸퀬옄猷뚮줈 솢슜 맆 닔 엳뒗 湲곗큹옄猷뚮 젣怨듯븯怨좎옄 븯떎.

옱猷 諛 諛⑸쾿

1. 긽

븳엫긽寃궗젙룄愿由ы삊쉶 떊鍮숇룄議곗궗 떒諛깅㈃뿭寃궗봽濡쒓렇옩 뿰 2쉶 닔뻾븯硫, 留ㅽ쉶 3媛쒖쓽 젙룄愿由щЪ吏덉쓣 궗슜븳떎. 2016뀈怨 2017뀈 媛곴컖 1, 2李⑥ 2018뀈 1李 떊鍮숇룄議곗궗봽濡쒓렇옩 RF 寃궗寃곌낵瑜 遺꾩꽍븯쑝硫 誘멸뎅 蹂묐━븰쉶(College of American Pathologist, CAP)뿉꽌 二쇨븯뒗 援쇅 쇅遺젙룄 愿由ы봽濡쒓렇옩 寃곌낵瑜 븿猿 遺꾩꽍븯뿬 援궡·쇅 룞猷뚯쭛떒(peer group) 寃곌낵瑜 鍮꾧탳븯떎. 삉븳 援궡 떆뙋 以묒씤 RF 젙꽦寃궗 떆빟젣뭹 5醫낆쓣 긽쑝濡 寃궗젙蹂댁瑜 痍⑦빀븯뿬 湲곗移 (cut-off)瑜 솗씤븯쑝硫 떆빟 援щℓ 썑 떎뿕쓣 떆뻾븯뿬 湲곗移 쟻젅꽦쓣 룊媛븯떎. 빐떦 떆빟뱾 LabSlide RF (IVD Lab Co., Suwon, Korea), ASAN RA Latex Reagent (Asan Pharmaceuticals Co., Seoul, Korea), RaPET RF (Stanbio Laboratory, Boerne, TX, USA), Rheumatoid Factor Latex Test (Pulse Scientific Inc., Burlington, ON, Canada), RF-100 (Teco Diagnostics, Anaheim, CA, USA) 벑씠뿀떎. RF 젙꽦寃궗 떆빟쓽 寃궗썝由щ뒗 쟾遺 씪뀓뒪쓳吏묐쾿씠뿀떎. RaPET RF, Rheumatoid Factor Latex Test, RF-100 벑 3 醫낆쓽 떆빟뿉뒗 뼇꽦 議곕Ъ吏덉씠 룷븿릺뼱 엳뿀吏留, LabSlide RF ASAN RA Latex Reagent 벑 2醫낆쓽 떆빟뿉뒗 룷븿릺 뼱 엳吏 븡븯떎.

2. 떎뿕옱猷

1李 떎뿕 10媛吏 냽룄쓽 긽뭹솕맂 젙룄愿由щЪ吏덇낵 蹂댁젙 臾쇱쭏쓣 궗슜븯뿬 닔뻾븯쑝硫, 2李 떎뿕 옄媛젣議고븳 샎二 삁泥 5媛吏 냽룄 긽뭹솕맂 젙룄愿由щЪ吏 1媛쒕 궗슜븯뿬 룊媛븯떎. 1李 떎뿕뿉 궗슜븳 긽뭹솕 臾쇱쭏 Rheumatoid Factor Calibrator Series Level 1-5 (Randox Laboratories, Crumlin, UK), Specific Protein Control Level 1, 3 (Randox Laboratories)怨 Liquicheck Rheumatoid Factor Level 1-3 (Bio-Rad Laboratories Inc., Hercules, CA, USA)씠뿀쑝硫, 2李 떎뿕뿉 궗슜븳 젙룄愿由щЪ吏덉 Liquichek Immunology Control Level 1 (Bio-Rad Laboratories Inc.)씠뿀떎. 삉븳 궪꽦꽌슱蹂묒썝 吏꾨떒寃궗쓽븰怨쇱뿉 RF 寃궗媛 쓽猶곕맂 삁泥 寃泥대 샎二쇳븯뿬 젙웾媛믪쓣 10 IU/mL 誘몃쭔, 10-15 IU/mL, 20-25 IU/mL, 25-30 IU/mL, 100 IU/mL 珥덇낵쓽 냽룄媛 릺룄濡 젣議고븯뿬 젙꽦寃궗 떆빟쓽 쓳吏 뿬遺瑜 뙋젙븯떎. 긽뭹솕 맂 젙룄愿由щЪ吏덇낵 옄媛 젣議고븳 샎二 삁泥쓽 젙웾媛믪 Roche Modular E170 (Roche Diagnostics, Mannheim, Germany) 옣鍮꾨줈 2踰 痢≪젙븯뿬 룊洹좉컪쓣 援ы븯떎. 떆빟 lot 媛 寃궗寃곌낵 李⑥씠 뿬遺瑜 솗씤븯湲 쐞븯뿬 1李 떎뿕怨 2李 떎뿕뿉꽌 RF 젙꽦떆빟 lot쓣 蹂寃쏀븯뿬 떆뻾븯떎.

3. 뙋젙 諛 遺꾩꽍

1李 떎뿕뿉꽌뒗 10媛吏 냽룄쓽 긽뭹솕 臾쇱쭏쓣 RF 젙꽦떆빟 젣議곗궗쓽 吏移⑥뿉 뵲씪 媛곴컖 8쉶뵫 遺꾩<븳 썑 뙋룆븯떎. 2李 떎뿕뿉꽌뒗 5媛吏 냽룄쓽 옄媛젣議고븳 샎二 삁泥怨 1媛吏 냽룄쓽 긽뭹솕맂 젙룄愿由щЪ吏덉쓣 媛곴컖 5쉶뵫 遺꾩<븳 썑 뙋룆븯떎. 媛 떎뿕뿉꽌 寃궗寃곌낵 뙋룆쓽 媛앷꽦쓣 쐞븯뿬 몢 紐낆쓽 寃궗옄媛 룞떆뿉 留⑤늿쑝濡 뙋룆븯쑝硫 젣議곗궗쓽 吏移⑥뿉 뵲씪 뼇꽦 諛 쓬꽦쑝濡 뙋젙븯떎. 엯옄媛 蹂댁씠吏留 紐낇솗븳 쓳吏묒긽쓣 愿李고븷 닔 뾾뒗 쐞뼇꽦쓽 寃쎌슦 쓬꽦쑝濡 뙋떒븯떎. 젙룄愿由щЪ吏덇낵 샎二 삁泥쓽 젙웾媛믪쓣 湲곗쑝濡 젙꽦떆빟쓽 씪移섎룄 諛 kappa 넻怨꾨웾쓣 怨꾩궛븯떎.

寃곌낵

떊鍮숇룄議곗궗봽濡쒓렇옩쓽 RF 젙웾寃궗 諛 젙꽦寃궗 넻怨꾨뒗Table 1뿉 젙由ы븯쑝硫 CAP뿉꽌 二쇨븯뒗 쇅遺젙룄愿由ъ쓽 RF 寃곌낵뒗 Table 2뿉 젙由ы븯떎. 援궡 떊鍮숇룄議곗궗봽濡쒓렇옩뿉꽌 1踰 寃泥 젙웾媛믪쓽 以묒븰媛믪 20 IU/mL 洹쇱쿂濡 遺遺꾩쓽 젙꽦떆빟 湲곗移 洹쇱쿂 닔移섎줈 異쒖젣릺뿀쑝硫, 2踰 寃泥댁 3踰 寃泥댁쓽 젙웾媛믪 媛곴컖 30-40 IU/mL, 40-50 IU/mL쓽 踰붿쐞濡 젙꽦떆빟 湲곗移섎 珥덇낵븯뒗 닔移섎 蹂댁떎. CAP뿉꽌 二쇨븯뒗 쇅遺젙룄愿由ъ쓽 寃쎌슦, 궙 냽룄 寃泥대뒗 遺遺 10 IU/mL 씠븯쓽 踰붿쐞쑝硫, 넂 냽룄 寃泥대뒗 100 IU/mL 씠긽쓣 蹂댁떎. 援궡 떊鍮숇룄議곗궗봽濡쒓렇옩怨 CAP뿉꽌 二쇨븯뒗 쇅遺젙 룄愿由ъ뿉꽌 쑀궗븳 냽룄쓽 RF 臾쇱쭏 뾾뿀떎.

Table 1 . Proficiency testing results for rheumatoid factor from the Korean Association of External Quality Assessment Service.

Year/roundCP-01 (IU/mL, %)CP-02 (IU/mL, %)CP-03 (IU/mL, %)No. of quantitative/qualitative test results
2016/first22.3 (54.7)33.1 (56.8)44.0 (67.4)310/95
2016/second20.0 (44.8)34.1 (56.3)47.0 (55.2)314/96
2017/first19.9 (43.0)34.0 (65.0)46.1 (70.0)334/100
2017/second20.3 (64.2)33.0 (48.5)45.7 (95.5)363/134
2018/first20.4 (72.3)36.1 (95.3)45.3 (97.3)402/148

Values are presented as median (positive %), unless otherwise stated..


Table 2 . Proficiency testing results for rheumatoid factor from the College of American Pathologists.

Year/roundRF-01 (IU/mL, %)RF-02 (IU/mL, %)RF-03 (IU/mL, %)RF-04 (IU/mL, %)RF-05 (IU/mL, %)
2016/first5 (1.9)5 (1.4)189 (99.9)193 (99.4)6 (2.4)
2016/second242 (99.4)134 (98.1)9 (8.5)10 (9.3)131 (97.7)
2017/first148 (99.3)2 (2.1)247 (99.7)96 (95.3)3 (2.1)
2017/second113 (99.3)2 (3.8)3 (3.7)210 (99.7)115 (98.8)
2018/first228 (99.6)196 (100.0)136 (98.4)3 (0.3)3 (0.7)

Values are presented as median (positive %), unless otherwise stated..


1, 2李 떎뿕뿉 궗슜븳 긽뭹솕 젙룄愿由щЪ吏덇낵 샎二 삁泥쓽 痢≪젙맂 젙웾 룊洹좉컪, 젣議곗궗 젙蹂댁쓽 紐⑹쟻媛 諛 踰붿쐞, RF 젙꽦떆빟쓽 lot 踰덊샇 諛 湲곗移 젙蹂댁 뙋룆寃곌낵뒗 Table 3뿉 젙由ы븯떎. 5媛쒖쓽 젙꽦떆빟 以 3媛 떆빟 湲곗移섍 20 IU/mL 씠뿀쑝硫 2媛쒕뒗 媛곴컖 8 IU/mL怨 10 IU/mL씠뿀떎. 몢 紐낆쓽 寃궗옄 媛 뙋룆寃곌낵뒗 紐⑤몢 씪移섑븯떎. 떎뿕寃곌낵 紐⑤뱺 젙꽦 떆빟 10 IU/mL 씠븯쓽 踰붿쐞뿉꽌 쓬꽦 냼寃ъ쓣 蹂댁쑝硫, 30 IU/mL 씠긽쓽 냽룄뿉꽌뒗 遺遺 뼇꽦 냼寃ъ쓣 蹂댁吏留 씪遺 떆빟뿉꽌뒗 쓬꽦 냼寃ъ씠 愿李곕릺뿀떎. Table 4뿉 媛 RF 젙 꽦떆빟쓽 젙웾媛믨낵쓽 씪移섎룄 諛 kappa 넻怨꾨웾쓣 湲곗닠븯떎. 젙꽦떆빟怨 젙웾媛믨낵쓽 씪移섎룄뒗 51.4%-100.0%瑜 蹂댁쑝硫, kappa 넻怨꾨웾 0.40뿉꽌 1.00源뚯쓽 媛믪쓣 蹂댁떎.

Table 3 . Positive rates of qualitative rheumatoid factor reagents used in this study.

VariableLotCut-off (IU/mL)/time (min)Level 1Level 2Level 3Level 4Level 5Level 6Level 7Level 8Level 9Level 10
First experiment
 ManufacturerRandoxRandoxRandoxRandoxBio-radRandoxBio-radRandoxRandoxBio-rad
 Measured value by Modular E170 (IU/mL)11.418.228.033.033.648.859.977.890.893.8
 Target value (range), IU/mL12.623.128.5 (22.8–34.2)40.532.7 (28.0–37.4)60.859.5 (52.9–66.1)82.1 (65.7–98.5)109.995.5 (86.5–105)
 LabSlide RF651803110/20%0%25%87.5%100%100%100%12.5%100%100%
 ASAN RA LatexS99320/10%37.5%50%100%100%100%100%50%100%100%
 RaPET RF65700520/30%0%62.5%87.5%100%100%100%100%100%100%
 RaPET RF65800520/30%0%100%100%100%87.5%100%100%100%100%
 RF Latex Test18051220/20%50%100%100%100%100%100%100%100%100%
 RF-100753488/20%25%100%100%100%100%100%100%100%100%
Second experiment
 ManufacturerPooled serumPooled serumPooled serumBio-radPooled serumPooled serum----
 Measured value by Modular E170 (IU/mL)7.9013.2522.9523.1027.80199.10----
 LabSlide RF651808110/20%0%100%100%100%100%----
 ASAN RA LatexH99520/10%0%0%0%100%100%----
 RaPET RF65800420/30%0%100%100%100%100%----
 RF Latex Test18163120/20%0%100%100%100%100%----
 RF-100770018/20%0%100%80%100%100%----

Table 4 . Agreement rates and Kappa statistics between rheumatoid factor qualitative and quantitative reagents.

VariableReagents

LabSlide RFASAN RA LatexRaPET RFRF Latex TestRF-100
First experiment
 Lot6518031S993657005/65800518051275348
 Agreement rate (%)62.586.295.0/98.895.082.5
 Kappa statisticNA0.620.86/0.960.83NA
Second experiment
 Lot6518081H99565800418163177001
 Agreement rate (%)83.366.7100.0100.051.4
 Kappa statistic0.570.401.001.000.80

怨좎같

2016뀈遺꽣 2018뀈源뚯 븳엫긽寃궗젙룄愿由ы삊쉶뿉꽌 떆뻾븳 떊鍮숇룄議곗궗궗뾽쓽 떒諛깅㈃뿭봽濡쒓렇옩쓣 遺꾩꽍븳 寃곌낵, RF 젙꽦寃궗 寃곌낵媛 젙웾寃궗 寃곌낵 씪移섑븯吏 븡뒗 쁽긽씠 留롮씠 愿李곕릺뿀떎. 2016-2017뀈 2뀈媛꾩쓽 떊鍮숇룄議곗궗궗뾽 寃곌낵瑜 遺꾩꽍빐 蹂대㈃ RF 젙웾媛믪씠 20 IU/mL 궡쇅씤 1踰 寃泥댁쓽 寃쎌슦, 젙꽦 寃곌낵뿉꽌 뼇꽦쓣 蹂댁씤 寃쎌슦뒗 50% 궡쇅떎. 湲곗移섍 20 IU/mL씤 젙꽦떆빟쓽 寃쎌슦 젙꽦 寃곌낵媛 쓬꽦쑝濡 뙋룆맆 媛뒫꽦 엳쑝굹 삁긽릺뒗 寃곌낵蹂대떎 뜑 留롮 쓬꽦 뙋젙씠 愿李곕릺뿀떎. 2踰, 3踰 寃泥댁쓽 寃쎌슦 젙웾寃궗瑜 닔뻾븳 遺遺꾩쓽 湲곌뿉꽌 30 IU/mL 씠긽쑝濡 蹂닿퀬븯쑝誘濡 젙꽦 寃궗寃곌낵뒗 遺遺 뼇꽦쑝濡 뙋젙릺뼱빞 븯吏留, 쓬꽦쑝濡 뙋젙맂 寃쎌슦媛 2踰 寃泥대뒗 35.0%-51.5%, 3踰 寃泥대뒗 4.5%-44.8%濡 긽떦엳 留롮븯떎. 젙꽦떆빟 湲곗移섎 긽쉶븯뒗 2踰, 3踰 寃泥댁뿉꽌 쓬꽦쑝濡 뙋젙맂 寃쎌슦媛 30% 씠긽씠뿀떎뒗 寃껋 RF 痢≪젙뿉꽌 젙꽦 寃궗떆빟쓽 젙솗룄媛 뼥뼱吏뒗 寃껋쓣 쓽誘명븳떎. 젣씪 넂 냽룄씤 3踰 寃泥(40-50 IU/mL)뒗 2017뀈 2李⑥ 2018뀈 1李 떊鍮숇룄議곗궗궗뾽뿉꽌 뼇꽦瑜좎씠 利앷뻽뒗뜲, 2踰 寃泥(30-40 IU/mL)쓽 寃쎌슦 2017뀈 2李⑥뿉꽌뒗 뿬쟾엳 궙 뼇꽦瑜좎쓣 蹂댁씠떎媛 2018뀈 1李⑥뿉꽌 95.3%濡 뼇꽦瑜좎씠 利앷뻽떎. 씠 媛숈 젙솗룄쓽 媛쒖꽑 媛 RF 젙꽦떆빟 젣議곗궗뿉꽌 젙솗룄瑜 뼢긽떆궎怨좎옄 븯뒗 끂젰쓽 寃곌낵씪 닔룄 엳吏留, lot 蹂솕뿉 뵲瑜 씪떆쟻 쁽긽씪 媛뒫꽦룄 諛곗젣븷 닔 뾾떎. 룞씪븳 젣議곗궗 떆빟쓣 궗슜븯뜑씪룄 lot뿉 뵲씪 떎瑜 寃곌낵瑜 蹂댁씪 닔 엳쑝誘濡 떆빟쓽 lot 愿由щ 넻빐 젙솗꽦쓣 怨꾩냽 쑀吏븯硫, 湲곗移 씠긽쓽 臾쇱쭏뿉꽌 뼇꽦 寃곌낵媛 씪愿릺寃 蹂댁씠룄濡 媛쒖꽑븷 븘슂媛 엳떎.

RF 젙꽦떆빟 媛먮쭏湲濡쒕텋由곗쑝濡 肄뷀똿맂 씪뀓뒪씤옄瑜 븿쑀븯怨 엳쑝硫, 씤媛 媛먮쭏湲濡쒕텋由곗쓣 궗슜븳 떆빟怨 넗겮 媛먮쭏 湲濡쒕텋由곗쓣 궗슜븳 떆빟 媛 寃곌낵 遺덉씪移섍 엳쓣 닔 엳쓬씠 븣젮졇 엳쑝굹 씠踰 뿰援ъ뿉 궗슜븳 떆빟뱾 紐⑤몢 씤媛 媛먮쭏湲濡 遺덈┛쓣 궗슜븳 寃쎌슦떎[4]. 븳렪 RF 젙꽦떆빟 룊媛뿉꽌 젣議곗궗뿉 뵲씪 媛숈 臾쇱쭏뿉꽌룄 떎뼇븳 寃곌낵瑜 蹂댁뒗뜲, 젣議곗궗쓽 湲곗移섍 떆빟쓽 떎젣 꽦뒫蹂대떎 궙寃 옒紐 꽕젙릺뼱 엳뼱 떊鍮숇룄議곗궗궗뾽 寃곌낵뿉룄 쁺뼢쓣 二쇱뿀쓣 媛뒫꽦씠 엳떎. 듅엳 湲곗移섍 8 IU/mL怨 10 IU/mL씤 떆빟뱾쓽 쐞쓬꽦 寃곌낵媛 留롮븯뒗뜲, RF 18 IU/mL 臾쇱쭏뿉꽌 遺遺 쓬꽦 寃곌낵瑜 蹂댁뿬꽌 떊鍮숇룄議곗궗궗뾽쓽 遺덉씪移 寃곌낵뿉 쁺뼢쓣 二쇱뿀쓣 寃껋쑝濡 깮媛곷릺硫, 빐떦 떆빟쓽 寃쎌슦 湲곗移섏쓽 寃利앹씠 쟻젅엳 씠猷⑥뼱졇 빞 븷 寃껋씠떎. 떊鍮숇룄議곗궗궗뾽쓽 怨좊냽룄 3踰 寃泥댁 쑀궗븳 40 IU/mL 씠긽쓽 臾쇱쭏濡 룊媛븳 蹂 뿰援ъ뿉꽌룄 遺遺 뼇꽦 냼寃ъ쓣 蹂댁떎. Prozone 슚怨쇰줈 怨좊냽룄쓽 떆猷뚯뿉꽌 諛섎濡 궙 媛믪씠 痢≪젙맆 媛뒫꽦씠 엳떎怨 븣젮졇 엳쑝誘濡 70 IU/mL 씠긽쓽 젙웾媛믪뿉꽌 젙꽦떆빟씠 쓬꽦쓣 蹂댁씤 寃쎌슦뒗 prozone 슚怨쇱뿉 쓽븳 媛뒫꽦쓣 怨좊젮빐빞 븳떎. 瑜섎쭏떚뒪 愿젅뿼 솚옄뿉꽌 떎젣 RF 뼇꽦엫뿉룄 遺덇뎄븯怨 삁泥 以묒쓽 怨쇰떎 빆泥대웾쑝濡 씤빐 쓬꽦 샊 빟뼇꽦 諛섏쓳쑝濡 굹굹뒗 prozone 슚怨쇨 엳쓣 닔 엳쑝誘濡 젙꽦寃궗 뙋룆 떆 二쇱쓽媛 븘슂븯떎.

씠踰 떎뿕뿉꽌 젙꽦媛믨낵 젙웾媛믪쓽 씪移섎룄뒗 떆빟 諛 떆빟 lot뿉 뵲씪 51.4%뿉꽌 100%源뚯 떎뼇븳 뼇긽쓣 蹂댁떎. 媛숈 떆빟쓽 寃쎌슦룄 lot씠 떎瑜 寃쎌슦 쟻寃뚮뒗 5%뿉꽌 留롪쾶뒗 30% 씠긽쓽 씪移섎룄 李⑥씠瑜 蹂댁뿬 떆빟 lot 愿由ъ쓽 以묒슂꽦씠 媛뺤“릺뿀떎. Kappa 넻怨꾨웾룄 떆빟 lot뿉 뵲씪 렪李④ 떖뻽쑝硫 씪遺 떆빟 lot 愿由 諛 젙솗룄 媛쒖꽑씠 븘슂븷 寃껋쑝濡 깮媛곹븳떎. 떎 뿕뿉꽌 궙 씪移섎룄 諛 kappa 넻怨꾨웾쓣 蹂댁씤 RF 젙꽦떆빟 湲곗移 냽룄媛 10 IU/mL 씠븯씤 떆빟뱾씠뿀뒗뜲, 怨쇨굅뿉 湲곗移 냽룄瑜 15, 20, 25 IU/mL뿉 뵲씪 議곗궗븳 뿰援ъ뿉꽌뒗 湲곗移 냽룄瑜 넂뿬꽌 瑜섎쭏떚뒪吏덊솚 吏꾨떒쓽 듅씠룄瑜 넂씠뒗 寃 뜑 以묒슂븯떎怨 異붿쿇븯떎[8]. 뜶留덊겕뿉꽌 吏꾪뻾맂 瑜섎쭏떚뒪 愿젅뿼씠 뾾뒗 9,712紐낆쓣 긽쑝濡 議곗궗븳 뿰援ъ뿉꽌 RF쓽 以 븰媛믪 18 IU/mL쑝硫[9], 援궡 뿰援ъ뿉꽌 瑜섎쭏떚뒪 愿젅뿼 솚옄援곗쓽 RF 룊洹좎 377.1±614.2 IU/mL씤뜲 鍮꾪븯뿬 嫄닿컯 議곌뎔뿉꽌뒗 1.9±8.5 IU/mL瑜 蹂댁떎[10]. 瑜섎쭏떚뒪 愿젅 뿼 솚옄뱾뿉꽌뒗 100 IU/mL 씠긽쓽 닔移섎 蹂댁씠뒗 寃쎌슦룄 醫낆쥌 蹂닿퀬릺誘濡 꼫臾 궙 냽룄瑜 湲곗移섎줈 젙븯硫 떎吏덉쟻쑝濡 瑜섎쭏떚뒪吏덊솚 吏꾨떒뿉 룄씠 릺湲곕낫떎뒗 留롮 쐞뼇꽦 寃곌낵瑜 珥덈옒븯뿬 遺덊븘슂븳 異붽寃궗瑜 쑀諛쒗븷 寃껋쑝濡 뿬寃⑥쭊떎.

CAP뿉꽌 二쇨븯뒗 떊鍮숇룄議곗궗궗뾽쓽 寃쎌슦, RF쓽 젙꽦寃곌낵 湲곌 媛 씪移섎룄媛 90.7%-100%濡 슦닔븳 寃곌낵瑜 蹂댁뿬二쇱뿀쑝굹, 빐떦 쇅遺젙룄愿由щЪ吏덉쓽 젙웾媛믪씠 10 IU/mL 씠븯嫄곕굹 100 IU/mL 씠긽씤 臾쇱쭏쓣 二쇰줈 궗슜븯湲 븣臾몄뿉 湲곌 媛 씪移섎룄媛 留ㅼ슦 넂寃 굹삩 寃껋쑝濡 蹂댁씤떎. 긽쟻쑝濡 湲곗移 뿉 洹쇱젒븳 9-10 IU/mL쓽 냽룄臾쇱쭏쓣 궗슜븳 寃쎌슦뿉 90.7%- 91.8%쓽 湲곌 媛 씪移섎룄瑜 蹂댁엫쑝濡쒖뜥 2-6 IU/mL쓽 냽룄臾쇱쭏쓣 궗슜뻽쓣 寃쎌슦쓽 96.2%-99.7%쓽 湲곌 媛 씪移섎룄뿉 鍮꾪빐꽌 궙 寃쏀뼢쓣 蹂댁떎.

씠踰 뿰援ъ뿉꽌 늿뿬寃⑤낵 留뚰븳 寃껋 鍮꾩듂븳 냽룄쓽 샎二쇳븳 궗 엺 삁泥 臾쇱쭏뿉 鍮꾪븯뿬 젙룄愿由щЪ吏덈줈 寃궗뻽쓣 븣쓽 쓳吏묐컲쓳냽룄媛 뜑 뒓졇떎뒗 젏씠떎. 떆猷 醫낅쪟뿉 뵲씪 痢≪젙寃곌낵媛 떖씪吏 닔 엳쓬 옒 븣젮졇 엳뒗뜲, 씠踰 뿰援ъ뿉꽌룄 젙룄愿由щЪ吏덉쓣 궗슜븳 寃쎌슦蹂대떎 샎二쇳븳 궗엺 삁泥쓣 궗슜뻽쓣 븣 쐞쓬꽦씠 뜑 쟻뿀쑝誘濡, 젙룄愿由щЪ吏덈줈 룊媛븳 쇅遺젙룄愿由 寃곌낵뿉 鍮꾪븯뿬 떎젣 엫긽寃궗떎뿉꽌 솚옄 寃泥대줈 寃궗뻽쓣 븣 젙꽦 떆빟뿉꽌쓽 쐞쓬꽦씠 뜑 쟻寃 諛쒖깮뻽쓣 媛뒫꽦씠 엳떎.

씠 뿰援ъ쓽 젣븳젏 瑜섎쭏떚뒪 愿젅뿼쑝濡 吏꾨떒맂 솚옄뱾쓽 삁泥쑝濡 젙꽦떆빟쓣 룊媛븳 寃껋씠 븘땲뼱꽌 瑜섎쭏떚뒪 愿젅뿼 吏꾨떒뿉 엳뼱꽌쓽 엫긽쟻 誘쇨컧룄 듅씠룄 벑쓣 援ы븷 닔뒗 뾾뿀떎뒗 젏씠떎. 삉븳 蹂 떎뿕뿉꽌뒗 Roche Modular E170 옣鍮꾨줈 痢≪젙븳 젙웾寃궗 寃곌낵瑜 젙꽦寃궗 寃곌낵 鍮꾧탳븯뒗뜲, 뿬윭 醫낅쪟쓽 젙웾痢≪젙옣鍮꾨줈 寃궗븯뿬 젙꽦寃궗 寃곌낵 鍮꾧탳/룊媛븯뒗 寃껊룄 異붽쟻쑝濡 븘슂븷 寃껋씠떎.

寃곕줎쟻쑝濡, 援궡 엫긽寃궗떎뿉꽌 궗슜릺뒗 RF 젙꽦떆빟 젙웾媛믨낵 긽떦븳 遺덉씪移섎 蹂댁쑝硫, 留롮 젙꽦떆빟뿉 빐 젙솗룄쓽 媛쒖꽑 諛 湲곗移섏쓽 쟻젅꽦뿉 븳 寃利앹씠 븘슂븷 寃껋쑝濡 깮媛곷맂떎. 엫긽寃궗떎뿉꽌 뿬嫄댁씠 맂떎硫 RF 痢≪젙 젙꽦 寃궗瑜 理쒖냼솕븯怨 젙웾寃궗瑜 븯뒗 寃껋씠 異붿쿇릺吏留, 遺뱷씠 븳 긽솴뿉꽌뒗 젙꽦寃궗瑜 떆뻾빐빞 븯뒗 寃쎌슦媛 엳떎. 1李⑥쟻 쑝濡 젣議곗궗뿉꽌 떆빟쓽 젙솗꽦쓣 넂씠硫댁꽌 떆빟꽦뒫쓣 룊媛 븷 닔 엳뒗 議곕Ъ吏덉쓣 異붽븯怨, lot 媛 蹂씠 理쒖냼솕 諛 쟻젅 븳 湲곗移섎 꽑젙븯젮뒗 끂젰씠 븘슂븯떎. 2李⑥쟻쑝濡 젙꽦寃 궗 떆빟 궗슜옄뒗 쟻젅븳 젙룄愿由щЪ吏덉씠굹 엫긽 寃泥대 씠슜븯뿬 떆빟쓽 쟻젅꽦 諛 떆빟 lot 媛 닔뻾뒫쓣 젙湲곗쟻쑝濡 寃利앺븯怨, 쇅遺젙룄愿由ъ뿉 李몄뿬븯뿬 젙솗룄 뿬遺瑜 솗씤븷 븘슂媛 엳떎. RF 젙꽦떆빟쓽 吏덉쓣 媛쒖꽑븯怨 젙솗븳 寃곌낵瑜 뼸湲 쐞빐 젣議곗궗 궗슜옄 紐⑤몢 끂젰빐빞 븷 寃껋씠떎.

媛먯궗쓽 湲

씠 끉臾몄 븳엫긽寃궗젙룄愿由ы삊쉶 2018뀈 븰닠뿰援щ퉬(2018-01) 吏썝뿉 쓽빐 씠猷⑥뼱吏 寃껋씠떎.

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