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1 HPV DNA chip The clinical significance of HPV DNA chip test in the management of Atypical Squamous Cells of Undetermined Significance
2 HPV DNA chip The clinical significance of HPV DNA chip test in the management of Atypical Squamous Cells of Undetermined Significance
3
4 Abstract List of tables I II III IV V
5 : ( ASCUS, Atypical squamous cells of undetermined significance ),. ASCUS, ASCUS HPV DNA chip. : ASCUS, HPV DNA chip,, 48. HPV DNA chip 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, : ASCUS 48 ( CIN II ) % 5
6 . 48 HPV DNA %. HPV DNA, 30.6%( 11/36 ), ( CIN I ) 33.3%( 1/3 ), ( CIN II ) 80%( 4/5 ), ( CIN III ) 100%( 2/2 ), 100%( 2/2 ). HPV DNA. HPV DNA chip, HPV DNA 88.9%, 69.2%, 96.4%, 40%. : ASCUS HPV DNA chip. 6
7 Abstract Objective: Cervical intraepithelial neoplasia ( CIN ) and invasive cervix cancer were detected in some case of Atypical squamous cells of undetermined significance ( ASCUS ) PAP smear. In this study, we attempted to assess the clinical significance of a cytologic diagnosis of ASCUS and determine the usefulness of HPV DNA chip test ( new diagnostic method for HPV ) in management and evaluation of ASCUS patients. Methods : This study was performed from 1. November 2001 to 30. June 2002 and included 48 cases of ASCUS who were evaluated by HPV DNA chip test and whose pathology was evaluated by punch biopsy, cone biopsy or hysterectomy. The result of type 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and 69 in HPV DNA chip test were categorized as high risk. Results: The detection rate of pathology of above CIN II in ASCUS was 18.8%( 9/48 ). The detection rate of high risk HPV DNA in ASCUS was 41.7%( 20/48 ). The detection rate of high risk HPV DNA in WNL or Reactive was 30.6%( 11/36 ), 33.3%( 1/3 ) in CIN I, 80%( 4/5 ) in CIN II, 100%( 2/2 ) in CIN III, 100%( 2/2 ) in invasive cervix cancer. Higher the grade of pathology, more the detection rate of high risk HPV DNA chip test. The sensitivity for 7
8 the prediction of pathology of above CIN II by HPV DNA chip test was 88.9% and specificity, negative predictive value, positive predictive value were 69.2%, 96.4% and 40%. Conclusion: The use of HPV DNA chip test in patients with ASCUS may provide usefulness in detection of pathology of CIN II, III and invasive cervix cancer. 8
9 List of tables Table 1. Age distribution of the patients of ASCUS Table 2. Pathologic diagnosis of ASCUS Table 3. High risk HPV detection rate in each pathologic diagnosis Table 4. Type of HPV in normal and CIN I patients Table 5. Type of HPV in CIN II, CIN III and invasive cancer patients Table 6. Correlation of pathologic diagnosis and high risk HPV DNA detection 9
10 I Papanicolaou, 1., 6-55% ( NCI ) The Bethesda system ( TBS ) ( ASCUS, Atypical squamous cells of undetermined significance ), ( LSIL ), ( HSIL ) TBS ( Atypical squamous cells ) ASC-UC ( Atypical squamous cells of undetermined significance ) ASC-H ( Atypcial squamous cells, cannot exclude HSIL ). (ASC ) ( reactive ) 10
11 ( SIL ) 5-13%,. ( human papilloma virus ).,... Hybrid Capture II.,, HPV DNA chip HPV DNA ASCUS. 11
12 II ( ASCUS ), HPV DNA chip ( punch biopsy ), ( cone biopsy ), 48., HPV DNA chip,,. HPV DNA chip 1. 12
13 2. cytobrush. HPV speculum cytobrush ( ) Neodin TM PCR kit. HPV DNA Neodin TM PCR kit 22 HPV type specific oligonucleotide probe gamma-globin probe, probe DNA ( target DNA ) PCR ( hybridization ). probe streptavidin-r-phycoerythrin dye HPV. HPV DNA chip 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, , 11, 34,40, 42, ,,. 13
14 3. 48.,,,,,. HPV DNA chip. 4. Fisher's exact test P value
15 III ( Table 1 ). 2. ASCUS ASCUS (75.0%), ( CIN I ) 3 ( 6.2% ), ( CIN II ) 5 ( 10.4% ), ( CIN III ) 2 ( 4.2% ), 2 ( 4.2% ) ( Table 2 ) %. 15
16 3. HPV DNA 48 HPV DNA %. HPV DNA, 11 ( 30.6% ), 1 ( 33.3% ), 4 ( 80% ), 2 ( 100% ), 2 ( 100% ) ( Table 3). HPV DNA. HPV DNA 100%. 4. HPV DNA HPV DNA HPV DNA. HPV DNA 16 18, ( Table 4 ). 16
17 5. HPV DNA HPV DNA %, % ( Table 5 ). 6. HPV DNA,,. HPV DNA %, HPV DNA %. HPV DNA %, HPV DNA % ( Table 6 ). ASCUS HPV DNA chip 88.9%, 69.2%, 96.4%, 17
18 40%, HPV DNA P value
19 Table 1. Age distribution of the patients of ASCUS Age of patients No. of patients(%) ( 16.7 ) ( 22.9 ) ( 31.2 ) ( 14.6 ) ( 12.5 ) ( 2.1 ) Total 48 ( 100 ) 19
20 Table 2. Pathologic diagnosis of ASCUS* Pathologic diagnosis No. of patients(%) Normal or reactive 36 (75 ) CIN I ** 3 (6.2 ) CIN II 5 (10.4 ) CIN III 2 (4.2 ) Invasive cancer 2 (4.2 ) Total 48(100) *ASCUS : Atypical squamous cells of undetermined significance **CIN : Cervical intraepithelial neoplasia 20
21 Table 3. High risk HPV* detection rate in each pathologic diagnosis Pathologic diagnosis No.of cases No.of patients of high risk (%) Normal or reactive (30.6 ) CIN I** 3 1 (33.3) CIN II 5 4 (80 ) CIN III 2 2 (100) Invasive cancer 2 2 (100) Total (41.7 ) *HPV : Human papillomavirus **CIN : Cervical intraepithelial neoplasia 21
22 Table 4. Type of HPV in Normal and CIN I patients Case No HPV** DNA type Pathologic diagnosis 1 6* Normal or Reactive 2 16 Normal or Reactive 3 18 CIN I*** 4 40* Normal or Reactive 5 51 Normal or Reactive 6 56 Normal or Reactive 7 58 Normal or Reactive 8 58 Normal or Reactive 9 68 Normal or Reactive 10 51,58 Normal or Reactive 11 45,66 Normal or Reactive 12 66,68 Normal or Reactive 13 35,42 Normal or Reactive 14 16,18,34 Normal or Reactive *low risk type HPV **HPV: Human papillomavirus ***CIN : Cervical intraepithelial neoplasia 22
23 Table 5. Type of HPV in CIN II, CIN III and invasive cancer patients Case No HPV *DNA type Pathologic diagnosis 1 16 CIN II** 2 16 CIN II 3 16 Invasive cancer 4 18 CIN III 5 45 CIN II 6 35 CIN II 7 33,35 Invasive cancer 8 33,51 CIN III *HPV: Human papillomavirus **CIN: Cervical intraepithelial neoplasia 23
24 Table 6. Correlation of pathologic diagnosis and high risk HPV DNA detection High risk HPV* DNA Pathologic diagnosis CIN I** CIN II Total (%) (%) (%) Negative 27 ( 69.2 ) 1 ( 11.1 ) 28 ( 58.3 ) Positive 12 ( 30.8 ) 8 ( 88.9 ) 20 ( 41.7 ) Total 39 (100) 9 (100) 48(100) *HPV: Human papillomavirus **CIN: Cervical intraepithelial neoplasia 24
25 IV. 12%, 1.. CIN I, CIN II, CIN III, CIS,,..,,, HPV DNA,,,., Papanicolaou I, II, III, IV, V
26 Papanicolaou Traut,,., % 2.,,.,,, 1988 Bethesda ( NCI ) PAP class II The Bethesda system ( TBS ). TBS,,,. TBS ASCUS, 26
27 ( LSIL ), ( HSIL ) 3. HPV, ASCUS. ASCUS,,, HPV, koilocytotic atypia TBS ASCUS ( Reactive ), ( SIL ), Papanicolaou class II,,,,, HPV.. ASCUS, 27
28 2-3,,, TBS ASCUS fabor reactive ( ), fabor SIL ( ), NOS ( not otherwise specified ) TBS ASCUS,,,, ASCUS., ASCUS ( ASC, Atypical squamous cell ). ASC SIL. ASC ASC-US ASC-H ASC-US ( Atypical squamous cells of undetermined significance ) SIL SIL ASCUS, fabor reactive ASCUS, NOS ASCUS, fabor SIL, ASC 95%. ASC-H ( Atypical squamous cells, cannot exclude HSIL ) HSIL HSIL 28
29 HSIL CIN II, CIN III ASC-US CIN II, CIN III ASC-US. ASC-H ASC 5-10%. ASC ASC 5%, SIL ASC ASC:SIL 2:1 3:1 5. ASCUS 2-11% 6., ASCUS %, %, % ASCUS 1.98%. ASCUS ASCUS 46.2%, 53.8% 10. ASCUS 10, ASCUS 29
30 5-13% 11. ASCUS,,,,,,, HPV DNA 12., ASCUS , ASCCP ASC-US ASC-H, ASC-US,, HPV DNA. HPV DNA 30
31 , SIL, ASC-H. 1960, 1980 ( HPV, Human papillomavirus ), HPV,, %. 99% 1 HPV. HPV, HPV, HPV. HPV 6, 11, 42, 43, 44 condyloma, HPV 16, 18 31
32 , HPV 31, 33, 35, 39, 45, 51, 52, 56, HPV E5, E7 HPV 18. HPV DNA 16 18, 31, 45., HPV HPV. HPV viral particle, HPV typing 100 HPV HPV HPV DNA HPV DNA. HPV DNA Liquid hybridization ( Hybrid capture system ) HPV type specific probe Dot blot hybridization, Southern blot hybridization, Filter in situ hybridization, HPV DNA 32
33 type specific PCR, general primer PCR, general primer set HPV DNA Dot blot hybridization, Microtiter plate hybridization, Line probe assay. HPV DNA, HPV DNA. HPV DNA chip HPV 22 type ( High risk group; 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 69 Low risk group; 6, 11, 34, 40, 42, 43, 44 ), HPV. HPV DNA,,,,,, scanner HPV DNA,. 33
34 HPV 3 HSIL. HPV HSIL,,. HPV borderline smear 21. HPV DNA. ASCUS HPV DNA LSIL, HPV DNA HSIL 22. Apgar ASCUS HPV DNA, HPV DNA,, 34
35 23. Cox ASCUS HPV DNA CIN II CIN III 93%, 27% 22. Hatch ASCUS CIN II CIN III HPV DNA 60% 24. HPV DNA ASCUS 25. Gideon ASCUS CIN II CIN III 24.6%., ASCUS HPV DNA CIN II CIN III 85.7%, 97%. HPV DNA CIN II CIN III 87%, 95.7% 24.6% 26. ASCUS HPV DNA CIN II 35
36 88.9%, 69.2% 41.7%. HPV, HPV DNA chip. ASCUS HPV DNA chip 6. Lorincz ASCUS DNA HPV, HPV DNA SIL, HPV DNA 6 HPV DNA 27. ASCUS HPV 36
37 ,, HPV, HPV. ASCUS HPV DNA, HPV 30, HSIL HPV DNA 31. HPV DNA HPV DNA,
38 V ASCUS, HPV DNA chip,, HPV DNA. 1. ASCUS %. ASCUS 18.8% HPV DNA %. HPV DNA, 38
39 11 ( 30.6% ), 1 ( 33.3% ), 4 ( 80% ), 2 ( 100% ), 2 ( 100% ). HPV DNA. 3. HPV CIN II 16, 18. ASCUS. 4.,,. HPV DNA %, HPV DNA %. HPV DNA %, HPV DNA %. ASCUS HPV DNA chip 88.9%, 39
40 69.2%, 96.4%, 40%, HPV DNA P value ASCUS HPV DNA chip,. 16, 18. HPV DNA chip. 40
41 1. Koss LG. The Papanicolaou test for cervical cancer detection. A triumph and a tragedy. JAMA 1989 Feb 3; 261(5): Soost HJ, Lange HJ, Lehmacher W, Ruffing-Kullmann B. The validation of cervical cytology. Sensitivity, specificity and predictive values. Acta Cytol 1991 Jan-Feb; 35(1): The revised Bethesda System for reporting cervical/vaginal cytologic diagnoses: report of the 1991 Bethesda workshop. Acta Cytol 1992 May-Jun; 36(3): Solomon D, Frahle WJ, et al. ASCUS and AGUS Critera, IAC Task Force Summary. Acta Cytol 1998; 42: Kurman RJ, Henson DE, Herbst AL, Noller KL, Schiffman MH. Interim guidelines for management of abnormal cervical cytology. The 1992 National Cancer Institute Workshop. JAMA 1994 Jun 15; 271(23): Pearlstone AC. Grigsby PW. Mutch DG. High rates of atypical cervical cytology: Occurence and clinical significance. Obstet Gynecol 1992; 80: ,,,,,. (ASCUS-LSIL). 1997; 40(2):
42 8.,,,. ASCUS, AGUS LSIL. 1997; 40: ,,,,,. Bethesda system "atypical squamous cells of undetermined significance". 1993; 4(20): Montz FJ, Bradley JM McCabe F et al. Natural history of minimally abnormal Papanicolaou smear. Obstet Gynecol 1992; 80: Jones HW III. Impact of the Bethesda system. Cancer 1995; 76(10Suppl): Williams ML, Rimm DL, Pedigo MA, Frable WJ. Histologic correlation of ASCUS: A university hospital s experience. Acta Cytol 1994; 38: Bowlin RB, Grillo D, Pittman KP, Lemos LB, Baliga M. Correlation of two ASCUS with cervical biopsy diagnoses: 492 cases from the Mississippi State Department of Health [abstract]. Acta Cytol 1996; 40: 1041A. 14. Terry RR. Management of patients with Atypical squamous cells of undetermined significance(ascus) on Papanicolaou smears. J Am Osteopath Assoc 1996; 96: Solomon D, Davey D, Kurman R, Moria rty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002 Apr 24; 287(16):
43 16. Wright TC Jr, Cox JT, Massad LS, Twiggs LB, Wilkinson EJ Consensus guidelines for the management of women with cervical cytological abnormalities.jama 2002 Apr. 24; 287(16): Brinton LA. Epidemiology of cervical cancer-overview, Munoz N. Bosch FX, Shah KV et al. eds. The epidemiology of cervic al cancer and Human Papillomavirus. Oxford, Oxford University Press 1992; Zur Hausen H. Papillomavirus in anogenital cancer as a model to understand the role of viruses in human cancer. Cancer Res 1989; 49: Lorincz AT, Reid R, Jenson AB, Greenberg MD, Lancaster W, Kurman RJ.Human papillomavirus infection of the cervix: relative risk associations of 15 common anogenital types. Obstet Gynecol 1992 Mar;79(3): Lorincz AT, Temple GF, Kurman RJ, Jenson AB, Lancaster WD. Oncogenic association of specific human papillomavirus types with cervical neoplasia. J Natl Cancer Inst 1987 Oct; 79(4): Cuzick J, Sasieni P,Davies P,Adams J,Normand C, Frater A,Van Ballegoooijen M,van Den Akker E, A systematic review of the role of human paillomavirus testing within a cervical screening programme. Health Technol Assess 1999: 3(14): Cox JT, Lorincz AT, Schiffman MH, Sherman ME, Cullen A, Kurman RJ. Human papillomavirus testing by hybrid capture appears to be useful in triaging women with a cytologic diagnosis of atypical squamous cells of 43
44 undetermined significance. Am J Obstet Gynecol 1995 Mar; 172(3): Apgar BS, Brotzman G. HPV testing in the evaluation of the minimally abnormal Papanicolaou smear. Am Fam Physician 1999 May 15; 59(10): Hatch KD, Schneider A, Abdel-Nour MW. An evaluation of human papillomavirus testing for intermediate- and high-risk types as triage before colposcopy. Am J Obstet Gynecol 1995 Apr;172(4 Pt 1):1150-5; discussion Ferris DG, Wright TC Jr, Litaker MS, Richart RM, Lorincz AT, Sun XW, Borgatta L, Buck H, Kramer L, Rubin R. Triage of women with ASCUS and LSIL on Pap smear reports: management by repeat Pap smear, HPV DNA testing, or colposcopy? J Fam Pract 1998 Feb; 46(2): Fait G, Kupferminc MJ, Daniel Y, Geva E, Ron IG, Lessing JB, Bar-Am A. Contribution of human papillomavirus testing by hybrid capture in the triage of women with repeated abnormal pap smears before colposcopy referral. Gynecol Oncol 2000 Nov; 79(2): Lorincz AT. Hybrid Capture method for detection of human papillomavirus DNA in clinical specimens: a tool for clinical management of equivocal Pap smears and for population screening. J Obstet Gynaecol Res 1996 Dec; 22(6): Wright TC, Sun XW, Koulos J. Comparison of management algorithms for the evaluation of women with low-grade cytologic abnormalities. Obstet 44
45 Gynecol 1995 Feb; 85(2): Sun XW, Ferenczy A, Johnson D et al. Evaluation of the Hybrid Capture human paillomavirus deoxyribonucleic acid detection test. Am J Obstet Gynecol 1995; 173: Nobbenhuis MA, Walboomers JM, Helmerhorst TJ, Rozendaal L, Remmink AJ, Risse EK, van der Linden HC, Voorhorst FJ, Kenemans P, Meijer CJ Relation of human papillomavirus status to cervical lesions and consequences for cervical-cancer screening: a prospective study. Lancet 1999 Jul 3; 354(9172): Ronnett BM, Manos MM, Ransley JE, Fetterman BJ, Kinney WK, Hurley LB, Ngai JS, Kurman RJ, Sherman ME. Atypical glandular cells of undetermined significance (AGUS): cytopathologic features, histopathologic results, and human papillomavirus DNA detection. Hum Pathol 1999 Jul; 30(7): Reid R, Greenberg MD, Lorincz A, Jenson AB, Laverty CR, Husain M, Daoud Y, Zado B, White T, Cantor D, et al. Should cervical cytologic testing be augmented by cervicography or human papillomavirus deoxyribonucleic acid detection? Am J Obstet Gynecol 1991 Jun; 164(6 Pt 1): ; discussion Ferenczy A. Viral testing for genital human papillomavirus infections: recent progress and clinical potentials. Int J Gynecol Cancer 1995 Sep; 5(5):
46 34.,,., : 3; Burke L. Cervicography: an alternative modality of cervical screening. Diagn Cytopathol 1991; 7(6):
Korean J Clin Lab Sci. 20, 3() : ์๋ฐ๊ฒฌํ๊ธฐ๋์ฉ์ดํ๋ฉฐ, PCR ๋ฐฉ๋ฒ์์ฌ์ฉํ์๊ธฐ๋๋ฌธ์๋ฎ์๊ฐ์ฒด์์ HPV๋๊ฒ์ถํ ์์์ด๋ฏผ๊ฐ๋๊ฐ๋์๊ทธ์ ์ฉ์ฑ์ด๊ธฐ๋๋๊ณ ์๋ค ( ์ด๋ฑ, 2005). ์ด์๊ตฐ์ฐ์๋ฃ์์ฐ๋ถ์ธ๊ณผ์์์๋ขฐ๋๋ Papanicolau smear
26 Korean J Clin Lab Sci. 20, 3() : 26-32 ISSN 738-35 The Relationship between Papanicolaou Smear Test and Human Papilloma Virus DNA Chip Test in the Uterine Cervix Young-Ju Lee, Ji-Hun Jung, and Da-Young
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Ann Clin Microbiol Vol. 16, No. 2, June, 2013 http://dx.doi.org/10.5145/acm.2013.16.2.87 ISSN 2288-0585 Prevalence and Genotype of Human Papillomavirus Infection and Risk of Cervical Dysplasia among Asymptomatic
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IR์ปฌ๋ผ ์ฐฉ์ํ์ ๋๋ฌธ์ด๋ผ๊ณ ํ ์ ์๋ค. KOSPI ์ง์์ ๋ณํ ์จ์ด๋ KOSPI ์ง์ ๋๋น ์๋์ ์ธ ๋ณ๋ํญ์ผ๋ก ์ธก์ ํ ์ต๊ทผ ์ฐ๋ฆฌ๋๋ผ ์ฃผ์์์ฅ์ ์ฃผ๊ฐ๋ณ๋์ฑ์ 1980๋ ์ดํ ์ต์ ์์ค์ ๊ทผ์ ํ ์ ๋๋ก ๋ฎ์์ก๋ค. ์ฐ๋ฆฌ๋๋ผ ์ฃผ๊ฐ๋ณ๋์ฑ, ๊ธ๋ก๋ฒ ์์ฅ๋ณด๋ค ๋น ๋ฅด ๊ฒ ๊ฐ์ 19
2016. 2 ํต๊ถ ์ 185ํธ ๋ฐํ์ผ : 2016๋
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IR์ปฌ๋ผ 01 _ IR์ปฌ๋ผ ๋ณ๋์ฑ ์ปธ๋ ํ๊ตญ ์ฃผ์์์ฅ, ์ ์ํ ์ ์์ต ์์ฅ์ผ๋ก 03 _ CEO์ธํฐ๋ทฐ ๋ณ๋์ฑ ์ปธ๋ ํ๊ตญ ์ฃผ์์์ฅ, ์ ์ํ ์ ์์ต ์์ฅ์ผ๋ก
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Analyst ์ ์ฃผ์ฐ (639-4584) juyeon.yu@meritz.co.kr RA ๋ฐ์ง์ (639-451) jeeeun.park@meritz.co.kr 213.11.22 ์ ํต์
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