{"id":147148,"date":"2023-12-04T07:54:15","date_gmt":"2023-12-04T07:54:15","guid":{"rendered":"https:\/\/labinsights.com\/acf_article\/quan-ly-cac-thay-doi-ve-xet-nghiem-tai-mot-phong-xet-nghiem-tai-nhat-ban-nghien-cuu-dien-hinh-ve-qua-trinh-chuyen-doi-pivka-ii\/"},"modified":"2026-01-27T07:20:03","modified_gmt":"2026-01-27T07:20:03","slug":"managing-assay-changes-at-a-japanese-lab-a-case-study-in-pivka-ii-transition","status":"publish","type":"acf_article","link":"https:\/\/labinsights.com\/vi\/operations\/operational-excellence\/managing-assay-changes-at-a-japanese-lab-a-case-study-in-pivka-ii-transition\/","title":{"rendered":"Qu\u1ea3n l\u00fd c\u00e1c thay \u0111\u1ed5i v\u00ea\u0300 x\u00e9t nghi\u1ec7m t\u1ea1i m\u1ed9t ph\u00f2ng xe\u0301t nghi\u1ec7m ta\u0323i Nh\u1eadt B\u1ea3n: Nghi\u00ean c\u1ee9u \u0111i\u1ec3n h\u00ecnh v\u1ec1 qu\u00e1 tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i PIVKA-II"},"content":{"rendered":"

V\u1edbi t\u1ea5t c\u1ea3 n\u1ed7 l\u1ef1c c\u1ea7n thi\u1ebft \u0111\u1ec3 x\u00e2y d\u01b0\u0323ng v\u00e0 x\u00e1c nh\u1eadn m\u1ed9t d\u1ea5u \u1ea5n sinh h\u1ecdc m\u1edbi, c\u00f9ng v\u1edbi vi\u1ec7c \u0111\u00e0o t\u1ea1o nh\u00e2n vi\u00ean ph\u00f2ng x\u00e9t nghi\u1ec7m s\u1eed d\u1ee5ng \u0111\u00fang c\u00e1ch v\u00e0 h\u1ed7 tr\u1ee3 c\u00e1c b\u00e1c s\u0129 l\u00e2m s\u00e0ng chi\u0309 \u0111i\u0323nh xe\u0301t nghi\u00ea\u0323m \u0111\u00fang l\u00fac, \u00fd t\u01b0\u1edfng thay \u0111\u1ed5i c\u00e1c ho\u1ea1t \u0111\u1ed9ng hi\u1ec7n c\u00f3 \u0111\u1ec3 s\u1eed d\u1ee5ng m\u1ed9t thi\u1ebft b\u1ecb ho\u1eb7c d\u1ee5ng c\u1ee5 m\u1edbi c\u00f3 th\u1ec3 kh\u00e1 kh\u00f3 kh\u0103n. D\u01b0\u0323a va\u0300o nh\u01b0\u0303ng thay \u0111\u00f4\u0309i c\u00e2\u0300n thi\u00ea\u0301t, nh\u01b0\u0303ng ng\u01b0\u01a1\u0300i ph\u00f2ng x\u00e9t nghi\u1ec7m c\u1ea7n c\u1edfi m\u1edf v\u1edbi c\u00e1c d\u1ea5u \u1ea5n sinh h\u1ecdc m\u1edbi v\u00e0 c\u00f3 l\u1ed9 tr\u00ecnh tri\u1ec3n khai th\u00f4ng minh.<\/p>\n

G\u1ea7n \u0111\u00e2y, m\u1ed9t nh\u00f3m ph\u00f2ng x\u00e9t nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i B\u1ec7nh vi\u1ec7n Ch\u1eef th\u1eadp \u0111\u1ecf Osaka<\/a> \u1edf Nh\u1eadt B\u1ea3n \u0111\u00e3 chuy\u1ec3n t\u1eeb x\u00e9t nghi\u1ec7m PIVKA-II (protein induced by vitamin K absence or antagonist-II, protein th\u01b0\u0301 II \u0111\u01b0\u01a1\u0323c ta\u0323o ra do thi\u00ea\u0301u vitamin K ho\u0103\u0323c do c\u01a1 ch\u00ea\u0301 \u0111\u00f4\u0301i kha\u0301ng) n\u00e0y sang x\u00e9t nghi\u1ec7m kh\u00e1c, m\u1ed9t qu\u00e1 tr\u00ecnh li\u00ean quan \u0111\u1ebfn nhi\u1ec1u th\u00e1ch th\u1ee9c \u0111i\u1ec3n h\u00ecnh, c\u0169ng nh\u01b0 nhi\u1ec7m v\u1ee5 c\u1ee5 th\u1ec3 l\u00e0 qu\u1ea3n l\u00fd thay \u0111\u1ed5i \u0111\u01a1n v\u1ecb \u0111o l\u01b0\u01a1\u0300ng. \u0110\u1ec3 t\u00ecm hi\u1ec3u th\u00eam v\u1ec1 c\u00e1ch h\u1ecd a\u0301p du\u0323ng c\u1eadp nh\u1eadt n\u00e0y, Lab Insights \u0111\u00e3 ph\u1ecfng v\u1ea5n \u00f4ng Nobuhiro Sato, Tr\u01b0\u1edfng ph\u00f2ng C\u00f4ng ngh\u1ec7 X\u00e9t nghi\u1ec7m t\u1ea1i b\u1ec7nh vi\u1ec7n. Kinh nghi\u1ec7m c\u1ee7a \u00f4ng n\u00eau b\u1eadt m\u1ed9t s\u1ed1 nguy\u00ean t\u1eafc c\u01a1 b\u1ea3n trong qu\u1ea3n l\u00fd thay \u0111\u1ed5i x\u00e9t nghi\u1ec7m c\u00f3 th\u1ec3 \u00e1p d\u1ee5ng cho b\u1ea5t k\u1ef3 ph\u00f2ng x\u00e9t nghi\u1ec7m n\u00e0o.<\/p>\n

Qu\u00e1 tr\u00ecnh \u00e1p d\u1ee5ng x\u00e9t nghi\u1ec7m PIVKA-II<\/h2>\n

Testing cho PIVKA-II, m\u1ed9t d\u1ea5u \u1ea5n sinh h\u1ecdc \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 h\u1ed7 tr\u1ee3 ch\u1ea9n \u0111o\u00e1n ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan<\/a>, c\u00f3 th\u1ec3 cung c\u1ea5p \u0111\u1ed9 nh\u1ea1y cao h\u01a1n \u0111\u1ec3 ph\u00e1t hi\u1ec7n s\u1edbm ung th\u01b0 n\u00e0y khi gh\u00e9p n\u1ed1i v\u1edbi x\u00e9t nghi\u1ec7m protein AFP so v\u1edbi ch\u1ec9 x\u00e9t nghi\u1ec7m AFP [1]. T\u1ea1i c\u00e1c ph\u00f2ng xe\u0301t nghi\u1ec7m tr\u00ean kh\u1eafp th\u1ebf gi\u1edbi, x\u00e9t nghi\u1ec7m PIVKA-II \u0111ang \u0111o\u0301ng vai tro\u0300 b\u1ed5 sung cho c\u00e1c ph\u01b0\u01a1ng<\/a> ph\u00e1p ti\u1ebfp c\u1eadn c\u0169, cho ph\u00e9p c\u00e1c b\u00e1c s\u0129 l\u00e2m s\u00e0ng ch\u1ea9n \u0111o\u00e1n b\u1ec7nh s\u1edbm h\u01a1n v\u00e0 b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb khi co\u0301 c\u01a1 h\u1ed9i s\u1ed1ng cao nh\u1ea5t [2].<\/p>\n

Nh\u00f3m c\u1ee7a \u00f4ng Sato \u0111\u00e3 chuy\u1ec3n \u0111\u1ed5i th\u00e0nh c\u00f4ng t\u1eeb n\u1ec1n t\u1ea3ng th\u1eed nghi\u1ec7m PIVKA-II c\u0169 sang n\u1ec1n t\u1ea3ng m\u1edbi h\u01a1n, l\u1ef1a ch\u1ecdn h\u1ec7 th\u1ed1ng c\u00f3 th\u1eddi gian x\u1eed l\u00fd nhanh h\u01a1n v\u00e0 gi\u1ea3m t\u1ed5ng chi ph\u00ed v\u1eadn h\u00e0nh.<\/p>\n

\u201cL\u00fd do ch\u00fang t\u00f4i ch\u1ecdn c\u00e1c ch\u00e2\u0301t chi\u0309 \u0111i\u00ea\u0309m kh\u1ed1i u n\u00e0y l\u00e0 v\u00ec ch\u00fang \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng r\u1ed9ng r\u00e3i t\u1ea1i B\u1ec7nh vi\u1ec7n Trung t\u00e2m v\u00ea\u0300 Di truy\u1ec1n Ung th\u01b0 y ho\u0323c v\u00e0 c\u0169ng \u0111\u01b0\u1ee3c B\u1ec7nh vi\u1ec7n \u0110\u1ea1i h\u1ecdc Kyoto tr\u1ef1c thu\u1ed9c s\u1eed d\u1ee5ng.\u201d<\/p>\n

\u00d4ng Sato, ng\u01b0\u1eddi \u0111\u00e3 chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u ho\u0323c t\u00e2\u0323p \u0111\u1ec3 gi\u00fap c\u00e1c \u0111\u1ed3ng nghi\u1ec7p l\u00e2m s\u00e0ng hi\u1ec3u \u0111\u01b0\u01a1\u0323c l\u00fd do thay \u0111\u1ed5i n\u1ec1n t\u1ea3ng v\u00e0 ca\u0301ch hi\u1ec3u v\u00ea\u0300 c\u00e1c gi\u00e1 tr\u1ecb \u0111o l\u01b0\u1eddng kh\u00e1c nhau \u0111\u01b0\u1ee3c h\u1ec7 th\u1ed1ng m\u1edbi s\u1eed d\u1ee5ng, cho bi\u1ebft: “\u0110i\u1ec1u quan tr\u1ecdng l\u00e0 ph\u1ea3i gi\u1ea3i th\u00edch cho c\u00e1c b\u00e1c s\u0129 l\u00e2m s\u00e0ng l\u00fd do t\u1ea1i sao l\u1ea1i c\u00f3 s\u1ef1 thay \u0111\u1ed5i trong khoa x\u00e9t nghi\u1ec7m l\u00e2m s\u00e0ng v\u00e0 \u0111\u01b0\u01a1\u0323c h\u1ecd \u0111\u1ed3ng \u00fd s\u01b0\u0309 du\u0323ng v\u1edbi \u0111i\u0301ch theo d\u00f5i u”.<\/p>\n

Vi\u1ec7c \u0111\u00e0o t\u1ea1o nh\u00e2n vi\u00ean \u0111\u1ec3 c\u1ee7ng c\u1ed1 nh\u1eefng quan \u0111i\u1ec3m n\u00e0y c\u0169ng r\u1ea5t quan tr\u1ecdng. “Ch\u00fang t\u00f4i mu\u1ed1n \u0111\u1ea3m b\u1ea3o m\u1ecdi ng\u01b0\u1eddi c\u00f3 th\u1ec3 t\u1ef1 tin v\u00e0 t\u1ef1 h\u00e0o gi\u1ea3i th\u00edch c\u00e1ch ch\u00fang t\u00f4i \u0111i \u0111\u1ebfn k\u1ebft lu\u1eadn n\u00e0y ra sao”, \u00f4ng gi\u1ea3i th\u00edch. “Ch\u00fang t\u00f4i kh\u00f4ng mu\u1ed1n ch\u1ec9 l\u00e0 nh\u00e0 cung c\u1ea5p d\u1ecbch v\u1ee5 x\u00e9t nghi\u1ec7m.”<\/p>\n

\u00d4ng c\u0169ng tr\u00ecnh b\u00e0y ca\u0301c s\u00f4\u0301 li\u00ea\u0323u nghi\u00ean c\u01b0\u0301u t\u1ea1i c\u00e1c cu\u1ed9c h\u1ecdp \u0111\u1ec3 n\u00e2ng cao nh\u1eadn th\u1ee9c v\u1ec1 x\u00e9t nghi\u1ec7m m\u1edbi v\u00e0 gi\u00e1 tr\u1ecb c\u1ee7a n\u00f3 v\u01a1\u0301i b\u1ec7nh vi\u1ec7n, b\u00e1c s\u0129 v\u00e0 b\u1ec7nh nh\u00e2n trong vi\u1ec7c h\u1ed7 tr\u1ee3 ch\u1ea9n \u0111o\u00e1n ung th\u01b0 bi\u1ec3u m\u00f4 t\u1ebf b\u00e0o gan. “T\u00f4i ngh\u0129 r\u1eb1ng vi\u1ec7c chuy\u1ec3n \u0111\u1ed5i c\u00f3 th\u1ec3 di\u1ec5n ra su\u00f4n s\u1ebb n\u1ebfu m\u1ed9t \u0111\u1ec1 xu\u1ea5t \u0111\u01b0\u1ee3c \u0111\u01b0a ra d\u1ef1a tr\u00ean k\u00ea\u0301t qua\u0309 b\u1ed9 x\u00e9t nghi\u1ec7m t\u00f4\u0309ng t\u00ea\u0309, ch\u1eb3ng h\u1ea1n nh\u01b0 c\u1ea3i thi\u1ec7n hi\u1ec7u qu\u1ea3 x\u00e9t nghi\u1ec7m v\u00e0 gi\u1ea3m chi ph\u00ed v\u1eadn h\u00e0nh c\u0169ng nh\u01b0 th\u1eddi gian x\u1eed l\u00fd”, \u00f4ng l\u01b0u \u00fd. “S\u1ebd t\u1ed1t h\u01a1n n\u1eefa n\u1ebfu cu\u0300ng \u0111\u1eb7t v\u1ea5n \u0111\u1ec1 n\u00e0y v\u01a1\u0301i ca\u0301c m\u1ee5c ti\u00eau v\u00e0 ch\u1ee9c n\u0103ng c\u1ee7a b\u1ec7nh vi\u1ec7n, thay v\u00ec ch\u1ec9 t\u1eadp trung v\u00e0o m\u1ed9t h\u1ea1ng m\u1ee5c duy nh\u1ea5t”.<\/p>\n

X\u1eed l\u00fd c\u00e1c thay \u0111\u1ed5i \u0111\u01a1n v\u1ecb x\u00e9t nghi\u1ec7m<\/h2>\n

M\u1ed9t thay \u0111\u1ed5i c\u1ee5 th\u1ec3 m\u00e0 nh\u00f3m ph\u1ea3i x\u1eed l\u00fd l\u00e0 s\u1ef1 thay \u0111\u1ed5i \u0111\u01a1n v\u1ecb \u0111o l\u01b0\u1eddng \u0111\u01b0\u1ee3c b\u00e1o b\u1edfi h\u1ec7 th\u1ed1ng m\u1edbi. N\u1ec1n t\u1ea3ng n\u00e0y ba\u0301o gi\u00e1 tr\u1ecb theo \u0111\u01a1n vi\u0323 ng\/mL, v\u1edbi ng\u01b0\u1ee1ng 28,4, so v\u1edbi c\u00e1c h\u1ec7 th\u1ed1ng c\u0169 b\u00e1ogi\u00e1 tr\u1ecb theo \u0111\u01a1n vi\u0323 mAU\/mL v\u1edbi ng\u01b0\u1ee1ng 40. \u0110\u1ec3 tr\u00e1nh nh\u1ea7m l\u1eabn, nh\u00e2n vi\u00ean ph\u00f2ng x\u00e9t nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u00e3 ng\u1eebng hi\u1ec3n th\u1ecb c\u00e1c gi\u00e1 tr\u1ecb x\u00e9t nghi\u1ec7m cu\u0303 v\u00e0 \u0111\u01b0a ra gi\u1ea3i th\u00edch r\u00f5 r\u00e0ng c\u00f9ng t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn cho khoa Ti\u00eau h\u00f3a v\u1ec1 ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn m\u1edbi.<\/p>\n

\u0110\u1ed1i v\u1edbi c\u00e1c b\u00e1c s\u0129 l\u00e2m s\u00e0ng c\u1ea7n so s\u00e1nh k\u1ebft qu\u1ea3 m\u1edbi v\u1edbi k\u1ebft qu\u1ea3 c\u0169, m\u1ed9t b\u00e0i b\u00e1o nghi\u00ean c\u01b0\u0301u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00f4ng b\u00f4\u0301, n\u00f4\u0323i dung trong \u0111\u00f3 so s\u00e1nh hi\u1ec7u su\u1ea5t ch\u1ea9n \u0111o\u00e1n cho th\u1ea5y n\u1ec1n t\u1ea3ng m\u1edbi cung c\u1ea5p k\u1ebft qu\u1ea3 ch\u00ednh x\u00e1c nh\u01b0 nhau.<\/p>\n

V\u00ec gi\u00e1 tr\u1ecb c\u1ee7a c\u00e1c ch\u00e2\u0301t chi\u0309 \u0111i\u00ea\u0309m kh\u1ed1i u hi\u1ebfm khi \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng chi\u0309 ta\u0323i m\u1ed9t th\u01a1\u0300i \u0111i\u1ec3m duy nh\u1ea5t \u2014 gi\u00e1 tr\u1ecb c\u1ee7a ch\u00fang th\u01b0\u1eddng \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u00e0 so s\u00e1nh theo th\u1eddi gian \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 s\u1ef1 t\u0103ng ho\u1eb7c gi\u1ea3m m\u01b0\u0301c \u0111\u00f4\u0323 ho\u1ea1t \u0111\u1ed9ng \u2014 \u0111\u00f4\u0323i nho\u0301m c\u1ee7a \u00f4ng Sato hi\u1ec3u r\u1eb1ng khi co\u0301 ng\u00e0y c\u00e0ng nhi\u1ec1u k\u1ebft qu\u1ea3 theo th\u1eddi gian, vi\u1ec7c chuy\u1ec3n sang c\u00e1c \u0111\u01a1n v\u1ecb \u0111o l\u01b0\u1eddng kh\u00e1c cu\u0303ng s\u1ebd cho ph\u00e9p theo d\u00f5i ti\u00ea\u0301n tri\u00ea\u0309n cu\u0309a b\u00ea\u0323nh d\u1ec5 d\u00e0ng nh\u01b0 ph\u01b0\u01a1ng ph\u00e1p cu\u0303. Sau m\u1ed9t kho\u1ea3ng th\u1eddi gian chuy\u1ec3n ti\u1ebfp ng\u1eafn, vi\u1ec7c thay \u0111\u1ed5i \u0111\u01a1n v\u1ecb s\u1ebd kh\u00f4ng g\u00e2y r\u00f4\u0301i loa\u0323n cho b\u00e1c s\u0129 l\u00e2m s\u00e0ng ho\u1eb7c b\u1ec7nh nh\u00e2n.<\/p>\n

B\u00e0i h\u1ecdc v\u1ec1 qu\u1ea3n l\u00fd thay \u0111\u1ed5i<\/h2>\n

Ph\u00f2ng xe\u0301t nghi\u1ec7m c\u1ee7a \u00f4ng Sato, \u0111\u1ea1t ch\u1ee9ng nh\u1eadn ISO (International Organization for Standardization, T\u1ed5 ch\u1ee9c Ti\u00eau chu\u1ea9n h\u00f3a Qu\u1ed1c t\u1ebf) 15189 n\u0103m 2018, bao g\u1ed3m 65 k\u1ef9 thu\u1eadt vi\u00ean y t\u1ebf v\u1eadn h\u00e0nh nhi\u1ec1u n\u1ec1n t\u1ea3ng ch\u1ea9n \u0111o\u00e1n kh\u00e1c nhau cho c\u00e1c x\u00e9t nghi\u1ec7m sinh h\u00f3a, huy\u1ebft h\u1ecdc, mi\u1ec5n d\u1ecbch v\u00e0 vi sinh, c\u00f9ng nhi\u1ec1u loa\u0323i xe\u0301t nghi\u00ea\u0323m kh\u00e1c. Ph\u00f2ng x\u00e9t nghi\u1ec7m c\u0169ng m\u1edbi th\u00e0nh l\u1eadp nghi\u00ean c\u1ee9u gen ung th\u01b0, m\u1ed9t qu\u00e1 tr\u00ecnh li\u00ean quan \u0111\u1ebfn vi\u1ec7c x\u00e1c \u0111\u1ecbnh c\u00e1ch qu\u1ea3n l\u00fd th\u00f4ng tin.<\/p>\n

Sato l\u01b0u \u00fd r\u1eb1ng ph\u00f2ng th\u00ed nghi\u1ec7m c\u1ee7a \u00f4ng l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a nhi\u1ec1u hi\u1ec7p h\u1ed9i v\u00e0 t\u1eadn d\u1ee5ng m\u1ed9t s\u1ed1 h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ca\u0301c \u0111\u01a1n vi\u0323 kh\u00f4ng ng\u1eebng duy tr\u00ec c\u00e1c ti\u00eau chu\u1ea9n cao nh\u1ea5t v\u00e0 \u00e1p d\u1ee5ng c\u00e1c k\u1ef9 thu\u1eadt m\u1edbi nh\u1ea5t. Trong m\u1ed9t ph\u00f2ng xe\u0301t nghi\u1ec7m nh\u01b0 cu\u0309a \u00f4ng, vi\u1ec7c thay \u0111\u1ed5i n\u00ea\u0300n ta\u0309ng x\u00e9t nghi\u1ec7m l\u00e0 \u0111i\u1ec1u kh\u00f4ng th\u1ec3 tr\u00e1nh kh\u1ecfi.<\/p>\n

V\u1eady kinh nghi\u1ec7m c\u1ee7a \u00f4ng khi \u00e1p d\u1ee5ng x\u00e9t nghi\u1ec7m PIVKA-II ki\u00ea\u0309u m\u1edbi d\u1ea1y ch\u00fang ta \u0111i\u1ec1u g\u00ec? Sau \u0111\u00e2y l\u00e0 m\u1ed9t v\u00e0i \u0111i\u1ec3m ch\u00ednh r\u00fat ra:<\/p>\n