14-28,29-44.54-60, 104-111.54-60, 133-144,246- 259.
8. Pham Long Trong: (2001), Hinh anh X quang phdi binh thudng va benh ly. Compact dist Dai hoc y dUOc thanh phd Hd Chl Minh.
9. Alka M. Kanaya, David V.GIidden and Heniy F.
Chambe (2000). Identifying Pulmonary Tuberculosis in
patients with Negative Sputum smear Results., From the Division of General Internal Medecine and Infectious Diseases, University of Calfomia, San Francisco,CA 941431732. e-mail: [email protected]
10. Alvarez S, Shell C. Berk SL (1987). Radiographic presentation of tuberculosis in the elderiy Pulmonary tuberculosis in elderly men. Am J Med; 82; 602 - 606.
DANH GIA CHAT LUDNG CAC XET NGHIEM AST, ALT, BILIRUBIN-D VA BILIRUBIN-T QUA KET QUA NGOAI KIEM TRA CHAT LUITNG XET NGHIEM
TRAN HUTU T A M - Trung tim Kiim chuin Xet nghiem TP.HCM T A N G C H ( THUpNG - S6 Y tiTP.HCM
TOM T A T
Ngopi klim tra dit lupng xit nghipm (EQAs) li mdt tmng nhOng cdng cu quan trpng di phat hien sai so, theo doi, danh gii chit lupng, iCf dd glQp cic phdng xit nghiim thin khal dc hinh dpng phQ hpp nhim nang cao chat lupng [2l[3].[5],[8].
Nghiin cOu niy nhim phin tich chit lupng cac xit nghiim di bi sai si do tinh chit dac thu [1],[4]: AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), Bilirubin-D va Bilirubin-T, dupe thuc hiin trong nim 2014 tai cie phong xit nghiem hda sinh trin dia bin TP.HCM, cic tinh miin Tmng vi Ddng Bing Sdng CQu Long trong pham vi dia ban do Bd Y tiphin cdng Tmng tam Kiem chuin Xit nghiim TP.HCM triin khai dc hoat ddng kiim chuin. Kit qui ghi nhin, dii vdi hai men gan AST va ALT: vide thuc hiin cQa cic phdng xit nghiim vin cdn chua in dirih, sai si khi nhiiu bao gim nhOng sai si hp thing vi sai si ngau nhien, trong ba phudng phap xit nghiem thi phuong phip Tris buffer without pyridoxal - 5 - P IFCC/SFBC cd dp chinh xic eao nhat (CV% = 7.1 dii vdi AST vi 7,3 dii vdi ALT), phuong phip Coiorimetric cd dp chinh xic kem nhit (CV% = 31,4 dii vdi AST vi 36,5 dii vd( ALT). Dii vdi Bilirubin-D vi Bilimbin-T:
thdng si Bilimbin-T cd kit qui tUOng doi in dinh, tuy nhiin Bilirubin-D khdng in djnh, chat lupng dao ddng nhiiu qua eae miu, tmng bin phuong phap xit nghiem thi phuong phap Oxidation to Biliverdin ed dd ehlnh xic cao nhit (CV% = 7,4 dii vdi Bilirubin-D vi 5,1 dSi vdi Bitirubin-T), phuang phip Diazo with Sulphanilie Acid cd dd chinh xic kim nhit (CV% = 23,8 da vdi Blimbin-D vi9J dii vdi Bilimbln-T).
TCrkhod: Hda sinh, ngoai kiim, phdng xit nghiim, z-^core.
TU viit tit: BV (binh vien). PKDK (phdng khim da khoa), PXN (phong xit nghiem).
SUMMARY
EVALUATE QUALITY OF AST, ALT, BILIRUBIN-D AND BlLlRUBIN-T BY RESULTS FROM EXTERNAL QUAUTY ASSESSMENT SCHEME
The extemal quality assessment scheme (EQAs) is one of the most important tool to find out the errors, to supervise and evaluate quality, so that it helps medical laboratories expanding suitable acf/vMes to improve their quality [2].(3},[5],[8].
The aim of this study is to evaluate the quality of sensitive parameters, which easily meet eirors because of their specific character [1],[4]: AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), Bilirubin-D and Bilimbin-T, they were doing at the medical laboratories in Ho Chi Minh city and Central provinces, Mekong Delta provinces, where is the MOH territorial function of Center for Standardization and QC in Medical Labomtory of HCMC. The results, with AST and ALT: the medical laboratories revealed the unstability, there were many enors including systematic or random errors, in three diagnostic methods, the Tris buffer without pyridoxal - 5 - P IFCaSFBC had the most precise (CV% = 7.1 in AST and 7.3 in ALT), the Coiorimetric had the worst precise (CV% = 31.4 in AST and 36.5 in ALT), with Bilirubin-D and Bilirubin-T: the Bilirubin-T showed that the stability, but the Bilirubin-D did not, its quality fluctuated much by each sample, in four diagnostic methods, the Oxidation to Biliverdin had the most precise (CV%=7.4 in Bilimbin-D and 5.1 in Bilirubin-T), the Diazo with Sulphanilie Add had the worst precise (CV% = 23.8 in Bilimbin-D and 9.7 In Bilimbin~T).
Keywords: Biochemistry, EQA scheme, medical laboratory, z-score.
D A T VAN D i
Trong sd nhOng xet nghiem sinh hda. cac xet nghiem men gan AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), sac td mat Bilinjbln-D va Bilirubin-T la nhOng thdng so tuong ddi thudng quy diing de ddnh gid ehUe ndng gan mat hoac mpt so benh ly lien quan, tuy nhidn do tmh cliat dac thCi, cae thdng sd nay thudng d l bj sai sd faong qua trinh xet nghiem [1].[4].
Ngoai kiem tra chat ludng xet nghiem ngodi vtee la quy djnh bat budc ciia Bd Y td, cdn Id mdt cdng cu giup cdc phdng xet nghiem gidm saL kiem seat sal sd.
ddnh gid phUdng phap xet nghiem de ty dd ed nhiing nhan ^ n h khoa hpc vd hdnh ddng phii hpp trong viec ndng cao chat ludng xet nghiem phuc vu benh nhdn [2].[3],[5].[8].
Nghien euiu ndy sir dung cdc sd lieu ngoai kiem tra chat ludng ddi vdi cae thdng sd xet nghiem neu tren dude thuc hien tai cae phdng xet nghldm tren dja ban
Y HOC THi;C HANH (971) - S6 7/2015
TP.HCM, cdc tinh mien Tmng va £)dng Bang Sdng C ^ Long de ddnh gia tinh hinh, chat lupng thue hien cae xet nghiem neu ti'dn tai cac phdng xet nghiem, t y dd cd nhOhg nhdn i^nh va kien nghj tudng ling.
e O l TUpNG VA PHUONG P H A P NGHIEN CQU 1. D ^ tiipng
Thdng sd xet nghlOTi AST (/Aspartate Aminobansferase), ALT (Alanine Aminotransferase), Biiinjbin-D vd Bilirubin-T dupe thuc hien tai cdc phdng xet nghiem y hoc (PXN) tai thanh phd Hd Chi Minh (TP.HCM), eae ti'nh Ddng Bang Sdng Ciiu Long vd Ddng Nam Bd, Duyen Hai Nam Tmng Bd,...
2. Phuong phdp Phuong phap d t ngang md ta.
SCf dung ehi sd z-score, chi sd PT score, c h ^ RSZ, CV%, bieu d6 Shewhart. Bar-chart. k9 i ^ CUSUM de phdn tich d y lidu t y ket qua ngoai klemtn : chat luong xet nghiem ndm 2014 ciia Tmng tdm KM ! chuan Xet nghiem TP.HCM [41.[5].[6].[7]. ^
TTnh toan sd lidu dua trdn phdn mem Excel 2010 Stata 10.0.
KET QUA VA BAN L U ^ N
1. T y j e ket qua khong chap nhan qua 12 mlu ngoai kiem
NhOhg ket qua xet nghldm d z-score vudt ± 3 sdbj ket ludn Id khdng ehdp nhdn. phdng xdt nghldm p w cd bidn phdp khac phuc ddi v ^ cdc thdng sd dd. \ ^
Hinh 2. Ti le % z-score vifUt ±3 qua ti^g mau d thong sd Blilrubln-D va Blllrubln-T Bidu do bieu diln ti Id % z-score vupt ± 3 qua timg
m l u eho thdy ket qua khdng chdp nhan kha eao, ngoai thdng sd Bilimbin-T thuc hien tuong ddi dn dinh, cac thdng sd ALT, AST, Bllirutiin-D chua on ^ n h , chat lupng dao ddng nhieu. Ddc biet mdu 8 la m l u cd ndng dd thdp nhat trong chu ky thi cae PXN da bj sai nhieu, chiing td kha ndng xet nghiem d cdc mdu cd ndng dp thdp ciia eae PXN edn nhieu ban che.
2. Dp chinh xac cua cac phudng phap xet nghiem
Cd ba phuong phap dupe sG" dung de do thdng so ALT AST, ddi vdi tiidng sd Bilimbln-D va Bilirubin-T ed bdn phuOng phap do. Dya trdn CV% thu dupe tit ket qua ngoai kiem d a tat cae PXN tiiam gia tiAJng iifng vdi tiJng phutlng phap dd danh gia dp chinh xac cOa cae phuong phdp sCf dung.
D6i vdf thing si ALT. AST:
B a n g 1 . C V % c i i a c d c p h u O n g p h a p t h y c h i e n t h d n g s d A L T v d A S T q u a t i m g m a u
Mau 1 2 3 4 5 6 7 8 9 10 11 12 TB G t o a n
Colorimelric H.T 33,8 33,1 45,5 46,2 40,2 47,9 35,2 23,3 46,4 41,0 45,5 36,5 l i chiS; C ) 6 P X N
AST 33i 28,6 40,1 36,0 304 42,3 30,0 27,3 37,9 29.7 41.6 31.4 V % c O a h a m g i a
Tris Ixjffer with pyridoxal - 5 - P IFCC/SFBC ALT 9,3 10,9 5,9 4,9 9,7 5,3 9,7 14.4 5.0 8.6 4.8 10.1 8 i tOhg m ( n = 2 3 3
AST 14.9 15.8 8.5 11.7
m
6.717.0 22,8 7.4 9.8 7.4 9.6 12.2
Tns buffer witho
ALT pn 7.3 i^m fl.1 ^ p M 65*"p^B|
6.3 \^M 7,4 ' * ^ 5.9 ' P * v 8.3 'M^
11 <i. n t n 6.^ N ^
7,5 1 1 ^
5.7
N H 74 Y ^ 7.3 \^*iMUnh tor g ^
Y HOC THVC H A N H (971) - S 6 7/2011
Hinii 3. Bllu do CV% cOa tia pht/ong phjp ttiui; tilen tfi6ng s6 ALT AST
Trong 3 phimng phap xet nghiSm ALT va AST. phuang ptiap Tris buWer without pyridoxal -5-P IFCC/SFBC 6 CV% nho nhat (CV% = 7.1 doi vdi AST va CV% = 7,3 floi vai ALT), phtMng phap Coiorimetric co do chinh xac em nhit (CV% = 31,4 doi v6i AST va CV% = 36,5 doi vSi ALT).
B6I v6l thong s6Bilirubin-D vi Biiirubin-T:
Ba Mau
1 2 3 4 5 6 7 8 9 10 11 12 TB
n g 2 . C V % cOa c a c p h u o n q Diazo with Sulphanilie Add
BM) 19.9 21.8 27,1 27,9 19,5 26,0 20,7 29,3 284 19,3 25,9 19,8 23,8
Bil-T 11,6 12,6 77 6,9 11,3 7,0 12,2 12,8 7,3 10,2 6,9 10,6 97
p h a p t h i i c hi§r B i l i m b i n - D v Dichlorophenvl Diazonium
BiW 57 6,6 13,6 14,6 5,2 13,2 6,1 10,6 16,3 5,4 13,0 6,5 9,7
Bil-T 10,9 13,1 8,1 7,1 10,8 6.9 12,6 12,2 71 10,6 7.3 10,2 97
i B i l i r u b i n - T q u a tC/nq m l u Diazo wHl Didlioroanaiine
BW 9,4 12,1 16,2 15,5 8,8 13,0 10,9 22,4 13,9 9,3 117 9,5 127
Bli-T 8,2 8,3 6,2 5,8 9,4 6,0 9,5 11,2 6,3 8,3 6,0 8,2 77
Oxidation to Biiiventin BilD
6,3 6,4 7,3 8,2 7,6 6,1 8,3 9,7 7,6 7,6 7,0 6,8 7,4
Bii-T 5.1 5,2 5,5 5,0 5,0 5,4 47 5,6 4,2 5,0 57 5,3 5,1 G h i c h u : B i l - D ( B i l i r u b i n - D ) , B i l - T (Bilirubin-T).
Bilirubin Direct
^:£\^:^\^
Hinh 4. BiBU do CV% bon phUUng phap thut hl^n Bilimbin-D v i Bilimbin-T
Trong b5n phuang phap xet nghi§m thuc hien tren thong so Bilimbin-D v^ Bilimbin-T, phuong phap Oxidation 0 Biliveniin c6 do chfnh xac cao nhat (CV% = 7,4 d6\ vdi Bilirubin-D v^ CV% = 5,1 66\ v6i Bilirubin-T), phuang ihdp 0/azo w ^ Sulphanilie Add c6 do chinh xac kem nhat (CV% = 23,8 66\ vdi Bilirubin-D va CV% = 9,7 doi vdi lilimbin-T).
3. C h ^ lU^ng x6t nghiem tail cdc mite nong do cua thong so
Sai s6 c6 the tdp trung nhi^u tai mot m(ic nong dp cu the (thap, trung binh, cao), phan anh kha n3ng xet ighidm sai khi Mn hdnh tren mliu b^nh pham c6 n6ng do Cmg vdi mLJC nong do do. Phdn tfch ket qua thuc hien et nghiem d ^ vdi cdc tiidng s6 nghidn cijiu vd ve t»eu do, thu duuc ket qua nhu sau:
' HOC THUC H A N H (971) - S6 7/2015
Hinh S. Bieu do sir phan tan z-score theo n6ng d$ cfia ALT, AST
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Hinh 6. BIsu do sir phan tan z-score theo nong do cOa Blllrubin-D vk Blllmbin-T Vdi ket qua tren, ta nhdn thay sal so khi thuc hi#n
thong so AST, ALT va Bilirubin-D, Bilirubin-T deu c6 th^ xay ra 6 cac miJte n6ng dd. Trong do, sai so tuong ddi nhiSu vd mCrc dao ddng ket qua giu^ cac phong xet nghiem kha cao ddi vdi thdng sd AST, ALT (khi nong do > 100 U/L) vd thdng sd Bilirubin-D (khoang nong dd til 10 - 35 ^mol/L), Bilirubin-T (khoang ndng do tCf 70 - 100 Mmol/L).
K€T LUjSkN VA KIEN NGHj 1. Ket luan
K^t qua ngoai kiem khong chap nhan khd cao, ngodi tiidng sd Bilirubin-T thuc hien tuung ddi on ^ n h , cac tiidng so ALT, AST, Bilirubin-D chu^ on ^ n h , chat lupng dao ddng nhi^u.
Trong cac phuong phap xet nghiem, phuong phdp Tris buffer without pyridoxal -5-P IFCC/SFBC cd dd chinh xac cao nh^t khi xet nghiem AST vd ALT, phUOng phap Oxidation to Biliverdin cd do chinh xdc cao nh^t khi xet nghidm Bilimbin-D, Bilirubin-T.
Sal so deu c6 the xay ra d cac mCrc nong dp, trong dd kha ndng xay ra sal so nhieu ddi vdi AST vd ALT d mifc ndng dd > 100 U/L, ddi vdi Bilimbin-D vd Bilimbin- T, xay ra sai sd nhieu S mtJc n6ng do tCr 10 - 35 nmol/L (Bilimbin-D) hodc 7 0 - 1 0 0 ^mol/L (Biliaibin-T).
2. Kien nghj
Phdng xet nghiem can ten hdnh cac bien phap can tiiidp nhSm giam sai so d cdc xet nghiem AST, ALT, Bilimbin-D vd Bilimbin-T. Ddc biet quan tdm doi vdi cac
thdng sd cd ket qua xet nghiem dao ddng nhieu d facg
\
mOC nong dp trong phan ket luan. '^m Lou ^ danh gid vd chpn lira cac thiet bj, phuOn^
phdp x6t nghiem cd dp chinh xac cao d ^ thuc hien c ^
benh nhdn. ^ i T A I L I $ U THAM K H A O 'OM 1. Nguyin Dat Anh, Nguyin Thj Huwng (2013), ( ^
x^t ngtii^m thudng quy dp. dung trong ttiuc h^nh lam
sdng. NXB Y hpc, Ha Noi. " 1 ^ 2. Nguyin t a n B?nh, Tdng Chi Thupng, Nguyin Jm
Khoa, Trdn HiJu Tarn, L6 Thj ThCiy NhU. Tdn My K (2014), "Danh gia ket qua trien khai chinh sach q^, chat luang xet nghiem tai TP.HCM va cac ft'nh giai d 2007 - 2014-, Tap chl Y hoc Vf&t Nam, tap 421, ti.5-12,
3. BoYtg(2013), ThOngtU hudng dan thiJCNSr^
/j? chSt luang x6t nghiSm tai ca sd khdm b&nh, chOaM
sd 01/201 Sm'-BYT, Hd Noi. ^ 4. Trin HCru Tdm (2012), Ngoai kiim tra ch^t IM^
x6t nghiSm. NXB Y hoc, TP.Ho Chi Minh. S 5. Clinical and Laboratory Standards Institute (2^ra Assessment of laboratory tests when proficiency te^^M not available: Approved Guideline - Second Edition, C ^ ^ document GP29-A2, Vol.28 (21), Wayne. ": %
6. Intemational standard (1991) Sfiewhart corim
charts (IS08258:1991), Geneva. ^ 7. Intemational standard (1997) Cumulatm m^
chads — Guidance on Quality Control and data An^m using CUSUM Techniques (IS07871:1997), 6 e n e v a . J |
8. Intemational standard (2012), Medical laborataies - Requirements for quality and competence (ISO 15189:
2012), Geneva. «
Y HOC THI/C HANH (971) •