I HC QUC GIA H NI TRNG I HC KHOA HC T NHIấN - Trn Võn Chi NG DNG K THUT NAT (NUCLEIC ACID) PHT HIN SM S Cể MT CA VI RT HIV, HBV, HCV NGI CHO MU LUN VN THC S KHOA HC H Ni - 2015 Trần Vân Chi Luận văn Thạc sĩ Khoa học I HC QUC GIA H NI TRNG I HC KHOA HC T NHIấN - Trn Võn Chi NG DNG K THUT NAT (NUCLEIC ACID) PHT HIN SM S Cể MT CA VI RT HIV, HBV, HCV NGI CHO MU Chuyờn ngnh: Mó s: Vi sinh vt hc 60420107 LUN VN THC S KHOA HC Ngi hng dn khoa hc: PGS.TS Bch Khỏnh Hũa TS Trn Vn Tun XC NHN HC VIấN CHNH SA THEO GểP í CA HI NG Giỏo viờn hng dn Ch tch hi ng chm lun thc s khoa hc TS Trn Vn Tun PGS.TS Bựi Th Vit H H Ni - 2015 Trần Vân Chi Luận văn Thạc sĩ Khoa học LI CM N Li u tiờn, cho phộp tụi c by t lũng bit n sõu sc nht ti PGS.TS Bch Khỏnh Hũa; ngi thy ó tn tỡnh hng dn, giỳp tụi lm lun Ngi thy a tụi n vi Huyt hc Truyn mỏu, ngi thy ó truyn cho tụi nim am mờ vi Huyt hc Truyn mỏu Ngi thy ó bi dng cho tụi nhng c tớnh trung thc, cn mn ca mt ngi lm cụng tỏc nghiờn cu t nhng ngy u tiờn bc vo ngh Tụi xin by t lũng cm n sõu sc n BSCKII Phm Tun Dng ngi ó ng viờn cho tụi i hc cao hc v sut quỏ trỡnh hc Ngi ó tn tỡnh giỳp , dỡu dt tụi cụng tỏc Tụi by t lũng cm n sõu sc n TS Trn Vn Tun ngi ó hng dn ch dn, giỳp tụi lm lun Tụi cng xin chõn thnh cm n s giỳp on kt ca anh ch em ng nghip Khoa Xột nghim sng lc mỏu ó giỳp tụi hon thin s liu, mi iu kin thun li nht cho tụi sut quỏ trỡnh hc v lm lun Tụi xin gi li cm n ti: Ban lónh o Vin HHTMTW ó cp kinh phớ cho tụi i hc, cỏc khoa phũng hnh chớnh ó giỳp tụi hon thnh th tc hc tp, Khoa Di truyn v sinh hc phõn t, Khoa Thalassemia, Khoa Hemophilia, khoa HIV vin v sinh dch t ó cho phộp v giỳp tụi xột nghim nh lng virus, ton th Khi truyn mỏu ó to iu kin thun li cho tụi thc hin ti Tụi xin gi li cm n ti Phũng sau i hc, Khoa Sinh hc, B mụn Vi sinh hc ca trng i hc Khoa hc T nhiờn ó giỳp tụi hon thnh cỏc th tc lun Tụi xin by t lũng bit n ti cỏc bc b m , b m chng, chng ó giỳp ng viờn, dnh tỡnh cm v iu kin thun li cho tụi hon thnh lun Tụi xin by t lũng cm n n ngi hin mỏu ó cho tụi nhng s liu quý bỏu Hc viờn Trn Võn Chi Trần Vân Chi Luận văn Thạc sĩ Khoa học MC LC LI CM N i MC LC ii DANH MC CC Kí HIU V CH VIT TT iv DANH MC CC BNG v DANH MC CC HèNH, BIU vi M U CHNG TNG QUAN TI LIU 1.1 C IM SINH HC HIV, HBV, HCV 1.1.1 Bnh viờm gan B, tỡnh hỡnh nhim, c ch gõy bnh 1.1.2 Bnh viờm gan C, tỡnh hỡnh nhim, c ch gõy bnh 1.1.3 Bnh HIV/AIDS, tỡnh hỡnh nhim, c ch gõy bnh 15 1.2 MT S PHNG PHP XẫT NGHIM SNG LC HBV, HCV, HIV 22 1.2.1 Xột nghim Min dch HBV, HCV, HIV 24 1.2.2 Xột nghim sinh hc phõn t NAT 25 CHNG NGUYấN LIU V PHNG PHP NGHIấN CU 27 2.1 NGUYấN LIU 27 2.2 MY MểC V TRANG THIT B 27 2.3 PHNG PHP NGHIấN CU 28 2.3.1 Xột nghim sng lc dch HBV, HCV, HIV 30 2.3.2 Xột nghim sinh hc phõn t NAT HBV, HCV, HIV 33 2.3.3 Qun lý v x lý s liu 41 CHNG KT QU V THO LUN 42 3.1 KT QU XẫT NGHIM MIN DCH KHNG NGUYấN KHNG TH 42 3.1.1 T l HBsAg phn ng n v mỏu hin 42 3.1.2 T l anti HCV phn ng n v mỏu hin 44 3.1.3 T l HIV AgAb phn ng n v mỏu hin 47 3.1.4 T l nhim HBV, HCV, HIV bnh nhõn nhn mỏu nhiu ln 49 Trần Vân Chi Luận văn Thạc sĩ Khoa học 3.2 KT QU XẫT NGHIM NAT HBV, HCV, HIV 51 3.2.1 Kt qu xột nghim MP NAT 51 3.2.2 Kt qu xột nghim ID NAT 52 3.2.3 Kt qu xột nghim NAT (MP NAT, ID NAT) 53 3.2.4 KQXN t ngi cho mỏu NAT phỏt hin giai on ca s HBV 55 3.2.5 KQXN t ngi cho mỏu NAT phỏt hin giai on ca s HCV 59 3.2.6 KQXN t ngi cho mỏu NAT phỏt hin giai on ca s HIV 62 KT LUN 67 KIN NGH 68 TI LIU THAM KHO 69 PH LC Trần Vân Chi Luận văn Thạc sĩ Khoa học DANH MC CC Kí HIU V CH VIT TT NAT: Nucleic acid testing ADN: Axit deoxiribo nucleic ARN: Axit ribonucleic PCR: Phn ng chui trựng hp (Polymer chain reaction) IC: Chng ni (internal control) TMA: Phn ng khuch i qua trung gian (Transcription-Mediated Amplification) CMIA: Húa phỏt quang (Chemiluminescent Microparticle Immunoassay) ECLIA: in húa phỏt quang (Electronic Chemiluminescent Immunoassay) ELISA: Xột nghim dch gn men (Enzyme Linked Immunosorbent Assay) EIA: Xột nghim dch men (Enzyme Immunosorbent assay) HBV: Vi rỳt viờm gan B (Hepatitis B Virus) HCV: Vi rỳt viờm gan C (Hepatitis C Virus) HIV: Vi rỳt suy gim dch ngi (Human immunodeficiency Virus) AIDS: Bnh suy gim dch mc phi AE: Acridinium Ester Vin HHTMTW: Vin Huyt hc - Truyn mỏu Trung ng XN: Xột nghim KQXN: Kt qu xột nghim MD: Min dch KT: Khỏng th RIAs: Min dch phúng x (radioimmunoassays) Trần Vân Chi Luận văn Thạc sĩ Khoa học DANH MC CC BNG Bng 1.1: Xột nghim viờm gan B NAT sng lc n v mỏu [21] 23 Bng 3.1: T l HBsAg phn ng bng xột nghim dch 42 Bng 3.2: T l HBsAg ngi hin mỏu nghiờn cu so vi cỏc tỏc gi 43 Bng 3.3: T l anti HCV phn ng bng xột nghim dch 44 Bng 3.4: T l anti HCV phn ng ngi hin mỏu so vi cỏc tỏc gi 45 Bng 3.5: T l HIV AgAb phn ng bng xột nghim dch 47 Bng 3.6: T l HIV AgAb phn ng ngi hin mỏu so vi cỏc tỏc gi 48 Bng 3.7: T l nhim HBV, HCV, HIV bnh nhõn nhn mỏu nhiu ln ti Vin HHTMTW 49 Bng 3.8: Kt qu xột nghim MP NAT 52 Bng 3.9: Kt qu cỏc mu xột nghim ID NAT 52 Bng 3.10: T l HBV, HCV, HIV phn ng bng k thut MP NAT v ID NAT 53 Bng 3.11: T l HBV, HCV, HIV phn ng xột nghim ID NAT v MP NAT ngi hin mỏu so vi cỏc tỏc gi 54 Bng 3.12: KQXN t ngi hin mỏu giai on ca s HBV mó s BM2.11573 55 Bng 3.13: KQXN ngi hin mỏu giai on ca s HCV mó s ACA.67515 59 Bng 3.14: KQXN ngi hin mỏu giai on ca s HIV mó s ACA.78780 62 Bng 3.15: Xột nghim ngi hin mỏu giai on ca s HIV mó s AM9.97435 64 Trần Vân Chi Luận văn Thạc sĩ Khoa học DANH MC CC HèNH, BIU Hỡnh 1.1: Cu to ca HBV[63] Hỡnh 1.2: Chu trỡnh sng ca HBV [62] Hỡnh 1.3: S chuyn i huyt HBV (theo Michael P 2001) Hỡnh 1.4: Mụ hỡnh cu trỳc ca HCV [66] 11 Hỡnh 1.5: Chu trỡnh sng ca HCV [67] 14 Hỡnh 1.6: S chuyn i huyt HCV (Michael P 2001) 15 Hỡnh 1.7: Cu trỳc HIV (Hoffmann, 2007) 17 Hỡnh 1.8: Chu k sng ca HIV [65] 20 Hỡnh 1.9: S chuyn i huyt HIV (Michael P 2001) 22 Hỡnh 1.10: K thut Homogeneous ỏp dng xột nghim dch 25 Hỡnh 2.1: Mụ hỡnh nghiờn cu 29 Hỡnh 2.2: Phn ng húa phỏt quang CMIA (hóng Abbott) 31 Hỡnh 2.3: Phn ng in húa phỏt quang ECLIA (hóng Roche) 33 Hỡnh 2.4: Nguyờn tc bt gi trỡnh t ớch (hóng Grifol) 35 Hỡnh 2.5: Nguyờn lý khuch i TMA 36 Hỡnh 2.6: Phn ng ng hc DKA qua tớn hin AE 37 Biu 3.1: T l nhim HBV, HCV, HIV bnh nhõn nhn mỏu nhiu ln 50 Biu 3.2: T l HBsAg, anti HCV, HIV phn ng n v mỏu cỏc nm 2013, 2014, 2015 50 Hỡnh 3.1: Kt qu xột nghim ID-Cobasđ TaqScreen MPX PCR BM2.11573 58 Hỡnh 3.2: Kt qu xột nghim ID-Cobasđ TaqScreen MPX PCR mu ACA.67515 61 Hỡnh 3.3: Kt qu xột nghim ID-Cobasđ TaqScreen MPX PCR mu ACA.78780 63 Hỡnh 3.4: Kt qu xột nghim ID-Cobasđ TaqScreen MPX PCR mu AM9.97435 65 Trần Vân Chi Luận văn Thạc sĩ Khoa học M U Vi rỳt l mt nhng nguyờn nhõn gõy mt s bnh nghiờm trng ngi núi chung Riờng vi rỳt viờm gan B gi tt l HBV (Hepatitis B virus ), vi rỳt viờm gan C gi tt l HCV (Hepatitis C virus), vi rỳt gõy suy gim dch ngi HIV (Human immunodeficiency virus) l vi rỳt gõy bnh thụng qua ng mỏu Cỏc vi rỳt ny bin i liờn tc v cu trỳc v h gen trn thoỏt cỏc loi sinh phm xột nghim hu qu l tng t l lõy nhim cng ng Phng phỏp xột nghim dựng cho sng lc HIV, HBV v HCV lõy qua ng truyn mỏu l xỏc nh tỏc nhõn gõy bnh giỏn tip da trờn kt qu ca phn ng dch khỏng nguyờn-khỏng th u im ca xột nghim l n gin, tn ớt thi gian, giỏ thnh hp lý, song phng phỏp ny cú nhc im l giai on ca s ú khỏng th hoc khỏng nguyờn cha t ngng phỏt hin, vy xột nghim s cho kt qu õm tớnh Bờn cnh ú, tng tỏc khụng c hiu ca khỏng th hoc khỏng nguyờn vi nhng bt thng protein khỏc mỏu cú cu trỳc gn ging vi khỏng nguyờn hoc khỏng th cú th dn n kt qu dng tớnh gi Cựng vi s phỏt trin ca k thut sinh hc phõn t, k thut NAT ó c a vo s dng, k thut ny cú nhy cao cho phộp phỏt hin v nhõn bn c hiu theo hm m cỏc trỡnh t ớch ca tỏc nhõn gõy bnh t mt lng nh vi rỳt, ú, cho phộp phỏt hin sm v chớnh xỏc cỏc tỏc nhõn gõy bnh Hn th na, NAT cú th c s dng phỏt hin ng thi HIV, HBV v HCV thụng qua mt xột nghim thi gian l 4-5 gi, m bo an ton cho n v mỏu truyn Trờn Th gii, cỏc nc phỏt trin, m bo sng lc mỏu Anh, Phỏp, M, c thc hin xột nghim song song gia phng phỏp giỏn tip khỏng nguyờn khỏng th v xột nghim NAT cho n v mỏu t cui nhng nm 1990 u nhng nm 2000 Nm 1997, Hi ch thp c ó s dng PCR cho mc ớch sng lc HCV RNA cho ngi hin mỏu, tip theo l Nht Bn v Scotland Sau ú vo thỏng 3/1998 ngi ta ó gii thiu NAT cho xột nghim HCV RNA[50] Trần Vân Chi Luận văn Thạc sĩ Khoa học Vit Nam, hu ht cỏc phũng xột nghim sng lc HIV, HBV v HCV u s dng phng phỏp xột nghim dch khỏng nguyờn khỏng th hay cũn gi l xột nghim huyt hc, xột nghim NAT cha c s dng Nm 2008 ti cp B v ng dng NAT cho xột nghim sng lc mỏu t kt qu tt [3] n nm 2015, Vin HHTMTW thc hin theo Thụng t 26 TT-BYT ngy 16/9/2014 Hng dn hot ng truyn mỏu, trin khai xột nghim NAT m bo an ton truyn mỏu Xut phỏt t thc t trờn, chỳng tụi tin hnh nghiờn cu ng dng k thut NAT (nucleic acid) phỏt hin sm s cú mt vi rỳt HIV, HBV, HCV ngi cho mỏu nhm hng ti cụng tỏc xột nghim sng lc sm cỏc tỏc nhõn lõy qua ng truyn mỏu ny mt cỏch chớnh xỏc, m bo an ton, cht lng cho mỏu v ch phm s dng iu tr Mc tiờu nghiờn cu ca ti - Kho sỏt t l HBsAg, anti HCV, HIVAgAb phn ng trờn n v mỏu hin c xột nghim dch bng k thut CMIA, ECLIA T l nhim HBV, HCV, HIV bnh nhõn truyn mỏu nhiu ln - T l HBV, HCV, HIV phn ng phỏt hin bng k thut NAT (nucleic acid) trờn n v mỏu hin m xột nghim dch khụng phỏt hin c, theo dừi ngi hin mỏu cú phn ng k thut NAT, phỏt hin sm h gen vi rỳt nhm b tr cho xột nghim dch khỏng nguyờn- khỏng th Trần Vân Chi 10 Luận văn Thạc sĩ Khoa học KT LUN Xột nghim sng lc khỏng nguyờn khỏng th bng k thut CMIA, ECLIA vi t l HBsAg l 0,75%; 0,79%; anti HCV l 0,43%, 0,24%, HIV AgAb l 0,1%, 0,23% Bnh nhõn nhn mỏu nhiu ln cú t l nhim HBV l 5,9% nhim HCV l 23,89% Xột nghim NAT (nucleic acid) cú t l HBV, HCV, HIV tng ng l 1:1086 ; 1:192221; 2:192221 (HBV 0,92, HCV 0,0052, HIV 0,01) Nghiờn cu theo dừi c ngi hin mỏu mi nhim HIV giai on ca s huyt thanh, ngi mi nhim HCV giai on ca s, ngi nhim HBV giai on ca s Trần Vân Chi 75 Luận văn Thạc sĩ Khoa học KIN NGH Thc hin xột nghim sng lc mỏu bng k thut NAT b tr cho k thut dch khỏng nguyờn- khỏng th Nghiờn cu mt s trng hp nhim HBV th n OBI Trần Vân Chi 76 Luận văn Thạc sĩ Khoa học TI LIU THAM KHO TI LIU TING VIT V Thựy An v cng s (2012), Tỡnh hỡnh sng lc cỏc bnh nhim trựng qua ng mỏu ngi hin mỏu tỡnh nguyn khu vc ụng-Nam b ti Trung tõm truyn mỏu Ch Ry t 2009-2011, Tp Y hc Vit Nam, 396, 272-280 Phm Tun Dng v cng s (2014), Kt qu xột nghim sng lc HBV, HCV, HIV, giang mai ngi hin mỏu ti Vin Huyt hc Truyn mỏu TW nm 20122013, Tp Y hc Vit Nam, thỏng 10 s c bit, 45-50 Bch Khỏnh Hũa v cng s (2007), Xột nghim acid nucleic NAT phỏt hin sm vi rỳt HIV, viờm gan B, viờm gan C ngi cho mỏu, Tp nghiờn cu y hc, 4/51, 41-43 Nguyn Th Thu Hin v cng s (2012), Kt qu sng lc cỏc bnh nhim trựng lõy qua ng truyn mỏu ngi hin mỏu ti Hi Phũng 2008-2011, Tp Y hc Vit Nam, 396, 280-286 Lờ Th Hng v cng s (2012) Kt qu sng lc khỏng th HIV, khỏng th HCV, HBsAg, giang mai, st rột ngi hin mỏu tỡnh nguyn ti Bnh vin a khoa tnh Hũa Bỡnh 3/2007-3/2012, Tp Y hc Vit Nam, 396, 286-292 Phan Th Minh Hng v cng s (2009), Nghiờn cu tỡnh hỡnh nhim HIV, HBV, HCV bnh nhõn truyn 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LR, Bradley DW and Houghton M (1989), An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis, Science, 244: 362-364 37 Locarnini S, M.D, (2004), Molecular virology of Hepatitis B virus, Serminars in liver disease, 24: 3-10 38 Mahoney FJ (1999), Update on Diagnosis, Management, and Prevention of Hepatitis B virus infection, Clin MicrobioL Rev, 12: 351-36 39 Marion Vermeulen, Nico Lelie (2009), Impact of individual-donation nucleic acid testing on risk of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission by blood transfusion in South Africa, Transfusion; 49: 1115-1125 40 Mercier B., Burlot L., and Ferec C.(1999), Simultaneous screening for HBV ADN and HCV ARN genomes in blood donations using a novel TaqMan PCR assay, J Virol Methods, 77: 1-9 41 Michael NL, Herman SA, Kwok S, Dreyer K, Wang J, Christopherson C, Spadoro JP, Young KK, Polonis V, McCutchan FE, Carr J, Mascola JR, Jagodzinski LL, Robb ML (1999), Development of calibrated viral load standards for group M subtypes of human immunodeficienvy virus type and performance of an improved AMPLICOR HIV-1 MONITOR test with isolates of diverse subtypes, J Clin Microbiol, 37: 2557-2563 42 Michael K.Hourfar, Christine Jork, et all (2008) Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus, Transfusion; 48:1558-1566 Trần Vân Chi 80 Luận văn Thạc sĩ Khoa học 43 Peter M (2004), Coinfection with HIV and HBV: Diagnosis and Therapy, The PRN notebook, 9: 14-23 44 Prasun Bhattacharya (2007), Significant increase in HBV, HCV, HIV and syphilis infections among blood donors in West Bengal, Eastern India 2004-2005: Exploratory screening reveals high frequency of occult HBV infection, World J Gastroenterol; 13(27):3730-3733 45 Roche, Cobas Taq screen MPX test 46 Raymond D., Swan T (2004), Hepatitis C virus (HCV) and HIV/HCV coinfection: A critical review of research and treatment, Treatment Action Group, New York, 16: 266-288 47 Rekha Hans and Neelam Marwaha (2014), Nucleic acid testing- benefits and constraints, Asian Journal Transfusion Science; 8(1):2-3 48 R.N.Makroo, N.Choudhury, et all (2008) Multicenter evaluation of individual donor nucleic acid testing (NAT) for simultaneous detection of human immunodeficiency virus-1&hepatitis B&C viruses in Indian blood donors, Indian Journal Medical Res 127, pp 140-147 49 Satyam Arora, Veena Doda (2014), Sensitivity of individual donor nucleic acid testing (NAT) for the detection of hepatitis B infection by studying diluted NAT yield samples, Blood transfusion; 13(2):227-232 50 Silvano Wendel et al (2007), Primary screening of blood donors by NAT testing for HCV-RNA: Development of an in-house method and results, Rev Inst.Med.trop.S.Paulo 49(3):177-185 51 Soisaang Phikulsod (2009), One-year experience of nucleic acid technology testing for human immunodeficiency virus Type 1, hepatitis C virus, and hepatitis B virus in Thai blood donations, Transfusion;49:1126-1135 52 Triques K., Coste J., Perret JL., Segarra C., Mpoudi E., Reynes J, Delaporte E, Butcher A, Dreyer K, Herman S, Spadoro J, Peeters M (1999), Efficiencies of four versions of the AMPLICOR HIV-1 MONITOR test for quantification of different subtypes of human immunodeficiency virus type 1, J Clin Microbiol, 37: 110-116 53 UNAIDS in Vietnam, from www.unaids.org.vn Trần Vân Chi 81 Luận văn Thạc sĩ Khoa học 54 Vermeulen M, Coleman C, et al (2013), Sensitivity of individual-donation and minipool nucleic acid amplification test options in detecting window period and occult hepatitis B virus infection, Transfusion 53:10, 2459-2466 55 Yaseen SG., et al (2013), Evaluation of serological transfusion-transmitted viral diseases and mutliplex nucleic acid testing in malaysian blood donors, Transfusion Apheresis Scientic, 49(3), 647-510 56 Warner C., Greene(2007), A history of AIDS: Looking back to see ahead, Eur J Immunol, 37: 94-102 57 WHO (2000), Hepatitis C virus Fact sheet, No 164 58 World Health Organization (2002), Hepatitis B Department of Communicable Disease Surveillance and Response 59 WHO (2012), The Immunological Basis for Immunization Series, Module 22: Hepatitis B 60 WHO (2014), Guidelines for the screening, care and treatment of persons with hepatitis C infection 61 WHO (2015), Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection 62 www.foundation.org.vn 63 www.hivandhepatitis.com 64 http://www.niaid.nih.gov/factsheets/howhiv.htm Trần Vân Chi 82 Luận văn Thạc sĩ Khoa học Ph lc 1: Kt qu HBsAg cỏc mu xột nghim ln u dng tớnh S/CO 0,9 xột nghim lp li cho kt qu õm tớnh S/CO < 0,9 TT Mó mu Sinh phm 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 BM5.03206 BM2.0399 BM2.0639 AM8.8410 BM4.0666 Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Roche Elecsys HBsAg II ECLIA Abbott Architect HBsAg Qual II BM5.09441 AM8.87964 AM9.81640 AC1.67250 BM2.13113 BM4.10445 AM9.92687 AM9.92278 BM3.13968 AC1.71171 AC1.71206 BM7.01860 AC1.6255 AM4.8897 BM2.0235 BM3.0293 BM3.0293 AM9.7067 BM5.0331 BM6.0163 AM9.7173 BM5.0373 BM5.0369 BM3.0431 Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II XN ln u S/CO 0,899 1,08 4,34 2,78 0,996 XN lp li Ln1 Ln2 S/CO S/CO 0,72 0,45 0,56 0,70 0,80 0,71 0,56 0,60 0,578 0,779 0,961 1,00 1,28 1,12 5,14 1,37 0,911 2,77 0,919 0,954 2,16 0,93 2,09 1,89 0,91 1,93 2,35 4,26 2,98 1,37 1,13 2,27 16,37 3,17 0,574 0,66 0,56 0,832 0,542 0,542 0,839 0,358 0,722 0,55 0,427 0,787 0,23 0,21 0,17 0,19 0,18 0,26 0,19 0,19 0,25 0,19 0,20 0,14 0,689 0,803 0,53 0,859 0,692 0,641 0,79 0,331 0,835 0,521 0,475 0,774 0,17 0,17 0,23 0,22 0,19 0,23 0,19 0,22 0,21 0,16 0,17 0,17 Kt lun XN IDNAT n XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT TT Mó mu 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 AM8.7608 BM3.0443 BM3.0442 ACA.6187 BM1.0245 AM9.7195 ACA.6246 AM7.8554 AM8.8053 BM2.0563 ACA.6453 AM8.8363 BM5.0599 BM6.0147 BM2.0766 BM3.0771 BM3.0774 BM5.0737 AM7.8834 AM7.8894 BM1.0897 BM5.0895 Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II AM9.79748 BM5.09558 AM7.90138 AM8.88100 BM2.10798 AM9.82528 BM1.10840 AM8.92080 AM8.92990 AB6.01728 Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Sinh phm XN ln u S/CO 0,93 1,63 1,73 7,06 2,05 0,91 1,14 0,92 1,51 1,07 177,9 0,92 2,97 0,93 1,36 0,91 1,41 1,98 0,98 1,29 1,01 1,16 1,34 1,17 0,97 1,22 1,40 0,99 1,69 1,06 1,26 6,24 XN lp li Ln1 Ln2 S/CO S/CO 0,21 0,18 0,17 0,36 0,16 0,21 0,19 0,80 0,16 0,20 0,16 0,17 0,22 0,21 0,21 0,15 0,13 0,16 0,74 0,78 0,19 0,72 0,82 0,58 0,62 0,29 0,20 0,22 0,19 0,64 0,18 0,24 0,18 0,16 0,20 0,31 0,15 0,2 0,18 0,61 0,17 0,17 0,16 0,17 0,16 0,22 0,19 0,2 0,15 0,18 0,81 0,55 0,18 0,65 0,8 0,53 0,63 0,20 0,16 0,20 0,20 0,57 0,21 0,18 Kt lun XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT TT Mó mu Sinh phm 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 AC1.77301 AM8.76783 AM7.96368 AC1.78676 BM6.09265 BM8.00261 AC1.69762 AM9.94494 AB6.02133 BM8.01659 BM7.00512 BM7.01377 ACA.77539 AC1.70485 AB3.12311 BM9.01266 BM7.02879 BM7.03569 BM7.01940 BM7.05376 BM9.03699 Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II Abbott Architect HBsAg Qual II XN ln u S/CO 1,11 1,32 1,41 25,49 5,9 2,11 1,73 1,17 1,55 1,02 7,43 1,24 2,16 1,20 6,15 1,26 0,96 27,25 0,90 4,78 3,88 XN lp li Ln1 Ln2 S/CO S/CO 0,67 0,21 0,21 0,18 0,2 0,27 0,26 0,79 0,19 0,24 0,21 0,31 0,23 0,18 0,19 0,22 0,22 0,20 0,19 0,21 0,22 0,41 0,19 0,21 0,2 0,21 0,26 0,25 0,76 0,23 0,22 0,23 0,21 0,17 0,17 0,19 0,25 0,22 0,20 0,19 0,27 0,22 Kt lun XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT Kt qu anti HCV cỏc mu xột nghim ln u dng tớnh S/CO 0,9 xột nghim lp li cho kt qu õm tớnh S/CO < 0,9 TT Mó mu BM5.01633 AB2.14927 Abbott Architect anti HCV CMIA AM7.87281 Sinh phm XN lp li Ln1 Ln2 S/CO S/CO 0,89 0,88 0,81 0,80 XN IDNAT Abbott Architect anti HCV CMIA XN ln u S/CO 0,97 0,95 Kt lun Abbott Architect anti HCV CMIA 0,90 0,80 0,79 XN IDNAT XN IDNAT TT Mó mu BM1.15814 10 11 XN ln u S/CO XN lp li Ln1 Ln2 S/CO S/CO Abbott Architect anti HCV CMIA 0,92 0,89 0,74 XN IDNAT BM2.15707 Abbott Architect anti HCV CMIA 0,99 0,80 0,61 XN IDNAT AC1.63297 BM2.04688 AC1.68342 BM1.12742 ACA.75052 Roche Elecsys anti HCV II ECLIA Roche Elecsys anti HCV II ECLIA Roche Elecsys anti HCV II ECLIA Roche Elecsys anti HCV II ECLIA Roche Elecsys anti HCV II ECLIA Roche Elecsys anti HCV II ECLIA 1,05 0,90 0,91 0,96 0,91 0,89 0,84 0,89 0,82 0,86 0,69 0,65 0,89 0,69 0,57 XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT 0,92 0,86 0,84 XN IDNAT BM8.02147 Sinh phm Kt lun Kt qu HIVAgAb cỏc mu XN ln u phn ng S/CO 0,9 XN lp li cho kt qu khụng phn ng S/CO < 0,9 TT Mó mu Sinh phm 10 11 12 13 14 15 16 17 18 19 20 AC1.62813 AM8.75451 BM6.00036 AM7.83747 AM8.76576 AM8.70965 BM3.05796 BM2.05112 BM4.03634 BM3.07567 BM4.04941 BM4.04870 BM2.08986 AM8.86128 AM7.88315 AM7.88620 BM3.08509 AB1.16190 AM7.89208 AM8.8787 Roche Elecsys HIV AgAb Roche Elecsys HIV AgAb ECLIAECCCCEECLIAcombi combi combicombiPTPT Roche Elecsys HIV AgAb combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Roche Elecsys HIV AgAb combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi XN ln u S/CO 0,91 1,25 1,06 1,06 1,20 1,11 1,15 1,26 1,30 4,30 1,11 0,98 1,30 1,47 0,90 1,14 1,63 0,90 1,14 0,92 XN lp li Ln1 Ln S/CO S/CO 0,78 0,75 0,24 0,36 0,86 0,85 0,16 0,23 0,30 0,30 0,33 0,28 0,26 0,33 0,22 0,32 0,17 0,28 0,25 0,34 0,19 0,38 0,22 0,32 0,26 0,36 0,20 0,30 0,79 0,89 0,38 0,30 0,21 0,34 0,73 0,74 0,30 0,38 0,87 0,72 Kt lun XN IDNAT XN n IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT TT Mó mu 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 35 36 36 37 37 38 38 39 39 40 40 40 41 41 42 42 43 43 44 44 45 45 46 46 47 47 48 48 49 49 50 50 51 51 52 52 53 53 54 54 55 55 56 56 57 58 59 60 61 62 63 64 65 66 AM7.92913 BM6.05766 AM8.94768 AM8.96156 AM8.98879 AM8.98787 BM9.00802 BM9.00774 BM9.00902 BM7.04233 AC1.62550 AM8.74469 AM8.74475 AM8.74478 BM3.02106 AM8.75205 AM8.75692 AM9.70130 AM9.70324 AM9.70155 AM9.70340 AM9.70193 BM1.04795 AC1.63759 BM5.03063 BM6.00392 BM1.02620 BM1.03892 AM7.83356 BM6.00558 AM9.71025 ACA.61707 AM9.71501 BM5.03676 BM5.03700 AM7.84424 AB3.11678 ACA.61879 BM1.05154 Sinh phm Roche Elecsys HIV AgAb combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Roche Elecsys HIV AgAb combi Elecsys HIV AgAb Roche combi Elecsys HIV AgAb Roche combi Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Abbott Architect HIV AgAb combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Abbott Architect HIV AgAb combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Abbott Architect HIV AgAb combo Architect HIV AgAb Abbott combo Abbott Architect HIV AgAb combo XN ln u S/CO 0,95 0,92 2,23 0,91 0,97 1,31 0,99 1,31 1,02 0,94 2,09 0,88 1,28 0,83 1,26 1,07 0,93 0,79 1,51 1,39 1,52 0,87 2,67 0,91 0,80 0,98 0,80 1,04 1,31 0,87 0,83 0,84 1,45 1,25 1,03 1,13 2,34 1,25 0,84 XN lp li Ln1 Ln S/CO S/CO 0,33 0,31 0,88 0,85 0,42 0,38 0,87 0,79 0,23 0,30 0,26 0,33 0,23 0,33 0,15 0,23 0,21 0,30 0,52 0,35 0,23 0,17 0,26 0,34 0,29 0,28 0,71 0,69 0,35 0,20 0,14 0,18 0,55 0,50 0,18 0,09 0,12 0,12 0,09 0,11 0,11 0,10 0,21 0,12 0,13 0,14 0,22 0,22 0,10 0,24 0,25 0,20 0,47 0,73 0,18 0,09 0,2 0,16 0,08 0,12 0,45 0,11 0,15 0,18 0,20 0,18 0,10 0,22 0,22 0,17 0,25 0,11 0,13 0,25 0,16 0,17 0,33 0,14 Kt lun XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT TT Mó mu 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 757 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 AB5.01465 AM7.84714 BM4.01832 BM4.01814 BM1.05518 ACA.64203 AM8.81948 AM9.74649 AM9.72904 AM9.75473 AM9.75910 BM4.02958 BM3.05940 BM3.06287 BM3.06333 BM3.06344 AB5.01633 BM2.08636 AM8.86421 BM6.03770 BM3.09854 AM7.91048 AM9.82205 AM9.82216 AM8.92990 AC1.67163 AM8.76783 AC1.77883 BM3.13453 BM3.12457 ACA.73132 BM6.08652 BM6.09580 BM1.15100 BM8.01428 ACA.76502 AC1.70371 BM2.15303 ACA.77533 Sinh phm Abbott Architect HIV AgAb combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Abbott Architect HIV AgAb combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott combo Abbott Architect HIV AgAb combo Architect HIV AgAb Abbott combo Architect HIV AgAb Abbott Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb XN ln u S/CO 0,81 0,81 0,93 1,98 1,21 1,07 1,31 1,07 1,01 1,08 1,62 0,94 1,08 1,61 1,77 1,74 2,46 0,94 1,77 1,32 0,92 1,28 1,18 1,02 1,62 1,12 1,59 1,14 5,05 1,01 1,07 1,12 1,00 1,04 0,92 1,09 1,00 1,00 2,94 XN lp li Ln1 Ln S/CO S/CO 0,40 0,13 0,30 0,29 0,23 0,19 0,16 0,10 0,65 0,68 0,44 0,27 0,08 0,14 0,08 0,22 0,14 0,13 0,16 0,12 0,23 0,2 0,63 0,52 0,82 0,53 0,25 0,27 0,29 0,43 0,26 0,26 0,10 0,16 0,84 0,25 0,08 0,33 0,09 0,07 0,22 0,14 0,89 0,69 0,07 0,08 0,54 0,33 0,13 0,14 0,15 0,13 0,08 0,07 0,51 0,13 0,15 0,15 0,81 0,69 0,13 0,09 0,08 0,09 0,81 0,81 0,88 0,66 0,14 0,17 0,13 0,12 0,12 0,30 0,89 0,77 0,22 0,20 Kt lun XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT XN IDNAT TT Mó mu 99 100 101 ACA.77880 BM1.16064 AM9.98289 Sinh phm Abbott Architect HIV AgAb Abbott Architect HIV AgAb Abbott Architect HIV AgAb XN ln u S/CO 1,03 1,75 1,07 XN lp li Ln1 Ln S/CO S/CO 0,75 0,60 0,27 0,24 0,88 0,65 Kt lun XN IDNAT XN IDNAT XN IDNAT ... NGHIM NAT HBV, HCV, HIV 51 3.2.1 Kt qu xột nghim MP NAT 51 3.2.2 Kt qu xột nghim ID NAT 52 3.2.3 Kt qu xột nghim NAT (MP NAT, ID NAT) 53 3.2.4 KQXN t ngi cho mỏu NAT. .. Vi rỳt vi m gan B (Hepatitis B Virus) HCV: Vi rỳt vi m gan C (Hepatitis C Virus) HIV: Vi rỳt suy gim dch ngi (Human immunodeficiency Virus) AIDS: Bnh suy gim dch mc phi AE: Acridinium Ester Vin... KHOA HC T NHIấN - Trn Võn Chi NG DNG K THUT NAT (NUCLEIC ACID) PHT HIN SM S Cể MT CA VI RT HIV, HBV, HCV NGI CHO MU Chuyờn ngnh: Mó s: Vi sinh vt hc 60420107 LUN VN THC S KHOA HC Ngi hng