ルミネックス（LABScreen）法 - UMIN
抗体検査結果解析HP掲載 ルミネックス（LABScreen）法国 病院機構 南和歌 医療センター成海 仁在
LABScreen：総合解析解析内容 LABScreen参加施設概要 23thQCWS抗体有無の 致率 Negative･Positive Controlの施設間差について 各施設におけるデータ 較 �て
11sup.GSingle 5831S6031S6131S6231S6431S6651MultiⅠ&Ⅱ造 otalMixedⅠ&Ⅱ臓器移植Lab ID輸 関連No〇〇〇〇〇〇〇〇252
LABScreen参加施設概要No1234Lab ID31S0131S0331S0431S05Anti-Human IgG?882/7981Negative control20201720解析ソフトHLA FusionHLA FusionHLA FusionHLA Fusion測定機器Luminex ISLuminex xPONENTLuminex 3DLuminex 100/200531S069020HLA FusionLuminex 100/200631S098920HLA Fusion 4.3Luminex xPONENT731S109120HLA FusionLuminex xPONENT8931S1131S1291741920HLA Fusion 3.0HLA FusionLuminex 3DLuminex xPONENT具体的な判定基準nMFI 1000nMFI 1000nMFI 1000nMFI ��た。PRA : MFI値 600以上を陽性とするSingle : MFI値 1000以上を陽性とする《NBG トオフ値：1.2nMFI 1000nMFI る。1031S138018HLA Fusion 3.0Luminex 20011121331S1431S1631S17889164191919HLA FusionHLA Fusion 4.3HLA FusionLuminex 200Luminex xPONENTLuminex xPONENT1431S189020HLA FusionLuminex xPONENT1531S199020HLA FusionLuminex 19191,Jackson908875191918202019HLA FusionHLA FusionHLA FusionHLA FusionHLA FusionHLA FusionLuminex xPONENTLuminex xPONENTLuminex xPONENTLuminex xPONENTLuminex 100Luminex xPONENT2231S299120HLA FusionLuminex xPONENTカットオフ値 Mixed:NGB ratio 3.0Single:nMFI ��も陽性とする場合あり。2331S309320HLA FusionLuminex xPONENT通常Mixedのratio ine S369091909220202019HLA Fusion 4.1HLA FusionHLA Fusion 4.1HLA FusionLuminex xPONENTLuminex 100/200Luminex xPONENTLuminex xPONENT2831S372020HLA FusionLuminex 3D293031S3831S399?90?911920HLA FusionHLA FusionLuminex xPONENTLuminex 3D3131S409220HLA FusionLuminex xPONENT3231S429320HLA FusionLuminex xPONENT3331S436615HLA Fusion 3.0Luminex xPONENT343531S4431S4588?20HLA FusionHLA FusionLuminex100Luminex xPONENT3631S479218HLA FusionLuminex xPONENT3731S48?20HLA FusionLuminex 3D38394031S4931S5031S51719290,Southern Biotechnology:IgM201920HLA FusionHLA FusionHLA FusionLuminex 3DLuminex 3DLuminex xPONENT4131S527018HLA FusionLuminex 3D42434431S5331S5431S55929291181920HLA Fusion 4.3HLA FusionHLA FusionLuminex xPONENTLuminex 3DLuminex xPONENT4531S569020HLA FusionLuminex xPONENT4631S589119自家製ソフトLuminex xPONENT4731S608820HLA FusionLuminex xPONENT4831S619020HLA FusionLuminex xPONENT4931S628119HLA FusionLuminex xPONENT505131S6431S6692?18?HLA FusionHLA FusionLuminex xPONENTLuminex xPONENTnMFI LABScreen PRAはDefault・LABScreen Single るnMFI 1000nMFI 1000陽性 MFI 2000カットオフ値 600以上で陽性nMFI 1000nMFI 1000nMFI 1000MIX ・・・NBG ratio 1.5以上Single ・・・nMFI 1000以上BNV 1000 以上nMFI ��値。Single AntigenについてはMFI ed: PositiveThreshold �）SingleAntigen: Mixedの結果を参照しながら、ＭＦＩ 1000を陽性nMFI 1000PRAは，nMFI ��判定。Singleは，nMFI して判定。HLA Fusionの自動判定( ６以上を陽性）、nMFI て判定を行ったnMFI 1000LABScreen Mixedは、Cut off1.5. Luminex Single antigenは、Cut offは、MFI1000BNVがPRA: 500およびSingle: 断で陽性としている。nMFI 1000LABScreen Mixedは、Cut off1.5. Luminex Single antigenは、Cut offは、MFI1000nMFI 1000PRA MFI:500Single MFI:1000PRA:500Single:1000Ｍｉｘｅｄ：NBG ratio 2.0以上Single：nMFI 1000以上Ratio 3.0nMFI 1000nMFI 1000nMFI 1000
LABScreen参加施設概要LABScreen Single AntigenLABScreen Single Antigen ��SH310SH31SH3102 SH3103 SH3104 SH3105 SH3106SH3105 SH3106SH3101 SH3102 SH3103 SH3104 SH3105 SH3106 SH3101 SH3102 SH3103 SH3104 SH3105 SH3106 SH3101 SH3102 SH3103 SH3104 SH3105 SH3106 SH3101 SH3102 EC K CACACACACA C K MCMCM31S3831S39CA31S40CMECME CME CMEA CME CMECME31S42CMEDCMEDCMED凍結融解3回 20000Ｇ3時間遠心凍結融解3回 20000Ｇ3時間遠心31S43 AdsorbedOut処理 AdsorbedOut処理CMED FBS添CMED FBS添加31S44CMED FBS添加CMED M31S54C,ECE31S55CMACMA31S56CECE31S58CC31S60 CCC Kx4CCCLabIDLABScreen Mixedサンプル前処理LABScreen Multiサンプル前処理LABScreen PRAサンプル前処理
LABScreen 抗体有無の 致率.Class IClass 18.8未実施未実施未実施
検体の前処理 法の影響について
CMEDS44CMED ES44CMED の前処理 法の影響についてNegative Control NC ClassⅠ140120100806040200SH3101NC ClassⅠ250200150100500
��理S29MES13EMACS44CMED 2CMEDS44CMED FBSS14ES51ES13EMACS29MEMFI検体の前処理 法の影響についてSH3102NC ClassⅠ6005004003002001000Negative Control NC ClassⅡ140120100806040200
CS13EMACS28無処理S42CMEDS44CMED FBSS42CMEDS44CMED AS06CMAE450400350300250200150100500S64CMASH3102NC ��前処理 法の影響についてSH3101 NC ClassⅡ350300250200150100500
LABScreen Mixed,Multi
Negative control NC: 2S6680Trimmed 40S43S44S45S48S50S54S60S61S62S66Trimmed MeanLABScreen Mixed,MultiNegative control PC: 000
SH3101NC: 0Trimmed 40S43S44S45S48S60S61S62S66Trimmed MeanLABScreen Mixed,MultiSH3102NC: SD:Mean:-SD300250200150100
SH3103NC: SD:Mean:-SD3000SH3103 High Back 5S48S50S54S60S61S62S664000Trimmed S40S43S44S45S48S50S54S60S61S62S66Trimmed MeanLABScreen Mixed,MultiSH3104NC: SD:Mean:-SD200150
4S60S60-2S61S61-2S62S66S66-2S66-3S66-4sample NC sample 31151065731487833414915SH3103 Class Ⅱ NC7500S54, 6563S50, 62106000S48, 445245003000S48‐2, 3951S06, 2800S39, 1974S60, 1825S66, �データのみを提出願います
SH3105NC: 0S61S62S66120Trimmed 40S43S44S45S48S50S54S60S61S62S66Trimmed MeanLABScreen Mixed,MultiSH3106NC: SD:Mean:-SD350300250200150100
SH3101 PC: 45S48S60S61S62S6610000Trimmed 9S40S43S44S45S48S60S61S62S66Trimmed MeanLABScreen Mixed,MultiSH3102 PC: SD:Mean:-SD120001000080006000400020000
SH3103 PC: 1S62S6615000Trimmed 9S40S43S44S45S48S50S54S60S61S62S66Trimmed MeanLABScreen Mixed,MultiSH3104 PC: SD:Mean:-SD1200010000800060005000400020000
SH3105 PC: 45S48S50S54S60S61S62S6612000Trimmed 9S40S43S44S45S48S50S54S60S61S62S66Trimmed MeanLABScreen Mixed,MultiSH3106 PC: SD:Mean:-SD1200010000800060004000
LABScreen Mixed,Multi
LABScreen Mixed,Multi
LABScreen :6.0(S04)10 NBG �
LABScreen Mixed,Multi
LABScreen Mixed,Multi
LABScreen :6.0(S04)10 NBG �
スクリーニング試薬の抗体有無 致率についてLABScreen Mixed,Multi (総合結果より）Class ⅠClass 5252525252525252525 致率%1001001001001001001001005610010068 SH3103 class Ⅱ：一致率 56％ High back 結果に影響を与える【NBG Ratio】(検体 各ビーズ値 / 検体NCビーズ値）/（NC血清各ビーズ値 / NC血清NCビーズ値） SH3106 class Ⅱ: 一致率 68％①10 NBG 値(1.5 6.0)により最終判定結果に影響する
LABScreen PRA
LABScreen PRALABScreen PRA Class ⅠNegative Control NC140120Negative Control PC: SD: Mean:-SD1800016000: SD: Mean:-SD14000Trimmed MeanTrimmed Mean100806040120001000080006000400020200000S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58Negative Control未使用S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58Negative Control未使用
LABScreen PRALABScreen PRA Class ⅠSH3101NC300: SD: Mean:-SDSH3102NC400: SD: Mean:-SD350250200Trimmed MeanTrimmed Mean300150100250200150100505000S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58
LABScreen PRALABScreen PRA Class ⅠSH3103 Class Ⅰ NC6000: SD: Mean:-SDSH3104 NC500: SD: Mean:-SD4505000400Trimmed MeanTrimmed Mean35040003000200030025020015010010005000S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58SH3103 High Back ています。S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58
LABScreen PRALABScreen PRA Class ⅠSH3105 NC450: SD: Mean:-SDSH3106 NC600: SD: Mean:-SD400500300Trimmed MeanTrimmed Mean3502502001504003002001001005000S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58
LABScreen PRALABScreen PRA Class ⅠSH3101 PC: SD:Mean:-SD1400012000120001000010000Trimmed MeanTrimmed Mean14000SH3102 PC800060008000600040004000200020000: SD:Mean:-SD0S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58
LABScreen PRALABScreen PRA Class ⅠSH3103 PC1600014000SH3104 PC: SD: Mean:-SD14000120001200010000Trimmed MeanTrimmed Mean: SD: Mean:-SD100008000600080006000400040002000200000S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58
LABScreen PRALABScreen PRA Class ⅠSH3105 PC14000SH3106 PC: SD: Mean:-SD16000140001200012000Trimmed Mean10000Trimmed Mean: SD: Mean:-SD800060004000100008000600040002000200000S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S51 S56 S58
LABScreen PRALABScreen PRA Class ⅡNegative Control NCNegative Control PC: SD: Mean:-SD160140: SD: Mean:-SD1400012000120Trimmed MeanTrimmed S39S42S44S47S56S58Negative tive Control未使用
LABScreen PRALABScreen PRA Class ⅡNCSH3102160400140350120300Trimmed MeanTrimmed MeanSH3101: SD: Mean:-SD1008060NC: SD: Mean:-SD25020015040100205000S09 S13 S19 S20 S39 S42 S44 S47 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S56 S58
LABScreen PRALABScreen PRA Class ⅡSH3103NC: SD: Mean:-SDSH31042500300250Trimmed Mean2000Trimmed MeanNC: SD: Mean:-SD150010005002001501005000S09 S13 S19 S20 S39 S42 S44 S47 S56 S58SH3103 High Back ています。S09 S13 S19 S20 S39 S42 S44 S47 S56 S58
LABScreen PRALABScreen PRA Class ⅡNCSH3106300350250300Trimmed MeanTrimmed MeanSH3105: SD: Mean:-SD20015010050NC: SD: Mean:-SD2502001501005000S09 S13 S19 S20 S39 S42 S44 S47 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S56 S58
LABScreen PRALABScreen PRA Class ⅡPCSH3102140001400012000120001000010000Trimmed MeanTrimmed MeanSH3101: SD: Mean:-SD8000600040002000PC: SD: Mean:-SD800060004000200000S09 S13 S19 S20 S39 S42 S44 S47 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S56 S58
LABScreen PRALABScreen PRA Class ⅡSH3103PC: SD: Mean:-SDSH310416000PC: SD: Mean:-SD140001400012000Trimmed MeanTrimmed 00S09 S13 S19 S20 S39 S42 S44 S47 S56 S580S09 S13 S19 S20 S39 S42 S44 S47 S56 S58
LABScreen PRALABScreen PRA Class ⅡPCSH310614000160001200014000PC: SD: Mean:-SD1200010000Trimmed MeanTrimmed MeanSH3105: SD: Mean:-SD800060004000100008000600040002000200000S09 S13 S19 S20 S39 S42 S44 S47 S56 S58S09 S13 S19 S20 S39 S42 S44 S47 S56 S58
LABScreen PRAS13シグナルなし
LABScreen PRAS13シグナルなし
LABScreen PRAS13シグナルなし
LABScreen PRAS13シグナルなし
LABScreen PRAS13シグナルなし
LABScreen PRAS13シグナルなし
LABScreen PRAS13データの再解析Labo e SH3106SH3106SH3106SH3106SH3106Data BaselineLot.Class 7/17NC ��反応なし
LABScreen PRAS13データの再解析Luminex 100ISは現Lotのテンプレートと未対応S13 PRA class Ⅰdata400Beads 0SH31050SH31061234530313233343536373839404142Beads NumberCSVファイルのBeads 13施設コメントPRA にClassⅠ&Ⅱを使用していた
LABScreen PRASH3106 classⅡS39データの再解析Labo IDS09S09-2S13S19S20S39Sample IDSH3106SH3106SH3106SH3106SH3106SH3106Data neLot.Class 17NC �向
LABScreen PRASH3106 classⅡS39データの再解析SH3106 classⅡ 陰性Consensus: 1総合判定？S39施設コメントLABScreen Mixed・PRA・Supplementは抗体なし、Single Antigenは抗体ありと判定
スクリーニング試薬の抗体有無 致率についてLABScreen PRA （総合結果より）Class ⅠClass 1111101010101010 致率%100100100100100911001008010010090 SH3106 class Ⅰ: 一致率 91％ ��リブレーション実施日など) SH3106 class Ⅱ : 一致率 90％ BScreen Single Antigenの結果を踏まえた結果であった
スクリーニング試薬の抗体有無 致率についてLABScreen Mixed （総合結果より）Class ⅠClass 5252525252525252525 致率%1001001001001001001001005610010068LABScreen PRA （総合結果より）Class ⅠClass 1111101010101010 致率%100100100100100911001008010010090
LABScreen Single Antigen
immed S48S49S50S51S52S53S54S55S56S58S60S61S62S64Trimmed MeanLABScreen Single AntigenNegative Control NC Class Ⅰ140120Negative Control PC Class Ⅰ: SD:Mean:-SD100806040200Negative Control未使用*S26測定データ除外Negative Control未使用: �
48S49S50S51S52S53S54S55S56S58S60S61S62S64Trimmed S48S49S50S51S52S53S54S55S56S58S60S61S62S64Trimmed MeanLABScreen Single AntigenSH3101 Class Ⅰ NC250200SH3102 Class Ⅰ NC: SD:Mean:-SD1501005000*S26測定データ除外: �
immed S49S50S51S52S53S54S55S56S58S60S61S62S64Trimmed MeanLABScreen Single Antigen18000SH3101 Class Ⅰ PC16000SH3102 Class Ⅰ PC: �定データ除外: ータ除外
rimmed S50S52S53S54S55S56S58S60S61S62S64Trimmed MeanLABScreen Single AntigenNegative Control NC Class Ⅱ140120Negative Control PC Class Ⅱ: SD:Mean:-SD1008060402000Negative Control未使用*S26測定データ除外Negative Control未使用: ータ除外
49S50S52S53S54S55S56S58S60S61S62S64Trimmed S50S52S53S54S55S56S58S60S61S62S64Trimmed MeanLABScreen Single AntigenSH3101 Class Ⅱ NC350SH3102 Class Ⅱ NC: ��外: 除外
S48S49S50S52S53S54S55S56S58S60S61S62S64Trimmed S50S52S53S54S55S56S58S60S61S62S64Trimmed MeanLABScreen Single AntigenSH3101 Class Ⅱ PC1400012000SH3102 Class Ⅱ PC: タ除外: ータ除外
LABScreen Single Antigen SupplementNegative Control NC Class Ⅰ: SD:Mean:-SD250Trimmed Mean200150100500S09 S18 S20 S22 S25 S28 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61Negative Control未使用16000Trimmed Mean1400012000Negative Control PC Class Ⅰ: SD:Mean:-SD1000080006000400020000S09 S18 S20 S22 S25 S28 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61Negative Control未使用
LABScreen Single Antigen SupplementSH3101 Class Ⅰ NC: SD:Mean:-SD300Trimmed Mean250200150100500S09 S18 S20 S22 S25 S28 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61SH3102 Class Ⅰ NC350Trimmed Mean300: SD:Mean:-SD250200150100500S09 S18 S20 S22 S25 S28 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61
LABScreen Single Antigen SupplementSH3101 Class Ⅰ PC14000: SD:Mean:-SDTrimmed Mean120001000080006000400020000S09 S18 S20 S22 S25 S28 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61SH3102 Class Ⅰ PC14000: SD:Mean:-SDTrimmed Mean120001000080006000400020000S09 S18 S20 S22 S25 S28 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61
LABScreen Single Antigen SupplementNegative Control NC Class Ⅱ140Trimmed Mean120: SD:Mean:-SD100806040200S09 S18 S20 S22 S25 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61Negative Control未使用16000Negative Control PC Class ⅡTrimmed Mean14000120001000080006000400020000S09 S18 S20 S22 S25 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61Negative Control未使用: SD:Mean:-SD
LABScreen Single Antigen SupplementSH3101 Class Ⅱ NC: SD:Mean:-SD800700Trimmed Mean6005004003002001000S09 S18 S20 S22 S25 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61SH3102 Class Ⅱ NC350Trimmed Mean300: SD:Mean:-SD250200150100500S09 S18 S20 S22 S25 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61
LABScreen Single Antigen SupplementSH3101 Class Ⅱ PC14000Trimmed Mean12000: SD:Mean:-SD1000080006000400020000S09 S18 S20 S22 S25 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61SH3102 Class Ⅱ PC16000: SD:Mean:-SDTrimmed Mean14000120001000080006000400020000S09 S18 S20 S22 S25 S29 S30 S31 S37 S39 S42 S44 S45 S47 S49 S55 S56 S58 S61
1500010000Normalized MFILABScreen Single AntigenSH3101 LABScreen Single Antigen Class :02A*03:01A*02:03A*01:01
1500010000Normalized MFILABScreen Single AntigenSH3101 LABScreen Single Antigen Class Ⅰ 07A*02:05A*01:02
200001500010000Normalized MFILABScreen Single AntigenSH3101 LABScreen Single Antigen Class 01
200001500010000Normalized MFILABScreen Single AntigenSH3101 LABScreen Single Antigen Class Ⅱ 1*08:02DRB1*04:11DRB1*04:10DRB1*04:07DRB1*04:06
200001500010000Normalized MFILABScreen Single AntigenSH3102 LABScreen Single Antigen Class :02A*03:01A*02:03A*01:01
1500010000Normalized MFILABScreen Single AntigenSH3102 LABScreen Single Antigen Class Ⅰ :04B*
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Oyamada, Keiko Saito, Shoko Minemura, Daisuke Maruoka, Takeshi Tanaka, Tomoo Nakagawa, Tatsuro Katsuno, . Correspondence to: Makoto Arai, MD, Department of Gastro-enterology and Nephrology (K1), Graduate School of Medicine, Chiba University, Inohana 1-8-1, Chiba-City 260-8670, Japan. araim-cib@umin.ac.jp
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