Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection
2
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Background: Clinical specificity and sensitivity are essential factors in the adoption of a hu- man papillomavirus (HPV) test as a primary screening tool and test of cure after treatment of cervical cancer and precancerous lesions (High-Risk-Lesion). Using histologically-con- firmed High-Risk-Lesion-patient specimens with postoperative follow-ups, we performed clinical validation of the AdvanSure GenoBlot Assay (GenoBlot; LG Life Sciences, Korea). Methods: The study population included 100 cases with High-Risk-Lesion, 96 with high- risk genotype positive and cervical intraepithelial neoplasia (CIN) 1 or better, and 39 with HR-negative and better than CIN 1. Forty-eight High-Risk-Lesion cases received follow-up HPV exams after surgery. For validation as a test of cure, 48 preoperative specimens (PreOP) and 78 postoperative specimens (PostOP) from 48 subjects were separately ana- lyzed. The results of HPV DNA chip tests (HPVDNAChip; BioMedLab Co., Korea) and se- quencing were cross-compared. Results: The concordance rates for each genotype between HPVDNAChip and GenoBlot were between 96.3-100%. The accuracy of HPVDNAChip and GenoBlot was 87.9% and 96.6%, respectively. Genotype-based specificity for High-Risk-Lesion detection was higher than 87% for both assays; genotype 16 showed the highest sensitivity. In the PostOP group, the positive rates for HPVDNAChip and GenoBlot were 30.8% and 47.4%, respectively. Conclusions: GenoBlot showed a higher positive rate than HPVDNAChip for each geno- type, with concordance rate and accuracy being similar to previous reports. As a test of cure, GenoBlot performed better than the HPVDNAChip.
Abstract
Background: Clinical specificity and sensitivity are essential factors in the adoption of a hu- man papillomavirus (HPV) test as a primary screening tool and test of cure after treatment of cervical cancer and precancerous lesions (High-Risk-Lesion). Using histologically-con- firmed High-Risk-Lesion-patient specimens with postoperative follow-ups, we performed clinical validation of the AdvanSure GenoBlot Assay (GenoBlot; LG Life Sciences, Korea). Methods: The study population included 100 cases with High-Risk-Lesion, 96 with high- risk genotype positive and cervical intraepithelial neoplasia (CIN) 1 or better, and 39 with HR-negative and better than CIN 1. Forty-eight High-Risk-Lesion cases received follow-up HPV exams after surgery. For validation as a test of cure, 48 preoperative specimens (PreOP) and 78 postoperative specimens (PostOP) from 48 subjects were separately ana- lyzed. The results of HPV DNA chip tests (HPVDNAChip; BioMedLab Co., Korea) and se- quencing were cross-compared. Results: The concordance rates for each genotype between HPVDNAChip and GenoBlot were between 96.3-100%. The accuracy of HPVDNAChip and GenoBlot was 87.9% and 96.6%, respectively. Genotype-based specificity for High-Risk-Lesion detection was higher than 87% for both assays; genotype 16 showed the highest sensitivity. In the PostOP group, the positive rates for HPVDNAChip and GenoBlot were 30.8% and 47.4%, respectively. Conclusions: GenoBlot showed a higher positive rate than HPVDNAChip for each geno- type, with concordance rate and accuracy being similar to previous reports. As a test of cure, GenoBlot performed better than the HPVDNAChip.
참고문헌 (16)
- Arbyn M, "Trails comparing cytology with human papillomavirus screening", Lancet Oncol, 10, pp.935~936 (2009)
- Poljak M, "The Abbott RealTime High Risk HPV test is a clinically validated human papillomavirus assay for triage in the referral population and use in primary cervical cancer screening in women 30 years and older: a review of validation studies", Acta Dermatovenerol Alp Panonica Adriat, 22, pp.43~47 (2013)
- Cuschieri K, "Comparison of the sensitivities of three commercial assays for detection of the high risk HPV types 16, 18 and 45", J Virol Methods, 193, pp.147~150 (2013)
- Lloveras B, "HPV testing by cobas HPV test in a population from Catalonia", PLoS One, 8, pp.58153~ (2013)
- Castle PE, "Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study", Lancet Oncol, 12, pp.880~890 (2011)
- Satoh T, "Rapid genotyping of carcinogenic human papillomavirus by loop-mediated isothermal amplification using a new automated DNA test (Clinichip HPVTM)", J Virol Methods, 188, pp.83~93 (2013)
- Herraez-Hernandez E, "HPV Direct Flow CHIP: a new human papillomavirus genotyping method based on direct PCR from crude-cell extracts", J Virol Methods, 193, pp.9~17 (2013)
- Tao P, "Sensitive HPV genotyping based on the flow-through hybridization and gene chip", J Biomed Biotechnol, 2012, pp.938780~ (2012)
- 황유선, "Comparison of the AdvanSure Human Papillomavirus Screening Real-Time PCR, the Abbott RealTime High Risk Human Papillomavirus Test, and the Hybrid Capture Human Papillomavirus DNA Test for the Detection of Human Papillomavirus", Annals of Laboratory Medicine, 32(3), pp.201~205 (2012), 대한진단검사의학회[DOI]
- 송혜정, "Comparison of the performance of the PANArray™ HPV test and DNA chip test for genotyping of human papillomavirus in cervical swabs", BioChip Journal, 4(3), pp.167~172 (2010), 한국바이오칩학회
- An H, "HPV 9G DNA Chip: 100% Clinical Sensitivity and Specificity", JOURNAL OF CLINICAL MICROBIOLOGY, 50, pp.562~568 (2012), AMER SOC MICROBIOLOGY
- Baseman JG, "The epidemiology of human papillomavirus infections", J Clin Virol, 32(S1), pp.16~24 (2005)
- Bouvard V, "WHO International Agency for Research on Cancer Monograph Working Group. A review of human carcinogens--Part B: biological agents", Lancet Oncol, 10, pp.321~322 (2009)
- Arney A, "Molecular diagnositics of human papillomavirus", Lab Med, 41, pp.523~530 (2010)
- Lee GY, "Human papillomavirus (HPV) genotyping by HPV DNA chip in cervical cancer and precancerous lesions", INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, 15(1), pp.81~87 (2005), BLACKWELL PUBLISHING
- Um TH, "Comparison of HPV genotyping assays and Hybrid Capture 2 for detection of high-risk HPV in cervical specimens", Ann Clin Lab Sci, 41, pp.48~55 (2011)