Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection
BACKGROUND: Clinical specificity and sensitivity are essential factors in the adoption of a human 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-confirmed High-Risk-Lesion-pat...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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The Korean Society for Laboratory Medicine
2014
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3948825/ https://www.ncbi.nlm.nih.gov/pubmed/24624348 http://dx.doi.org/10.3343/alm.2014.34.2.127 |
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author | Kahng, Jimin Oh, Eun-Jee Lee, Hae Nam Lee, Dae Woo Kim, Yonggoo |
author_facet | Kahng, Jimin Oh, Eun-Jee Lee, Hae Nam Lee, Dae Woo Kim, Yonggoo |
author_sort | Kahng, Jimin |
collection | PubMed |
description | BACKGROUND: Clinical specificity and sensitivity are essential factors in the adoption of a human 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-confirmed 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 analyzed. The results of HPV DNA chip tests (HPVDNAChip; BioMedLab Co., Korea) and sequencing 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 genotype, with concordance rate and accuracy being similar to previous reports. As a test of cure, GenoBlot performed better than the HPVDNAChip. |
format | Online Article Text |
id | pubmed-3948825 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | The Korean Society for Laboratory Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-39488252014-03-12 Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection Kahng, Jimin Oh, Eun-Jee Lee, Hae Nam Lee, Dae Woo Kim, Yonggoo Ann Lab Med BACKGROUND: Clinical specificity and sensitivity are essential factors in the adoption of a human 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-confirmed 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 analyzed. The results of HPV DNA chip tests (HPVDNAChip; BioMedLab Co., Korea) and sequencing 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 genotype, with concordance rate and accuracy being similar to previous reports. As a test of cure, GenoBlot performed better than the HPVDNAChip. The Korean Society for Laboratory Medicine 2014-03 2014-02-13 /pmc/articles/PMC3948825/ /pubmed/24624348 http://dx.doi.org/10.3343/alm.2014.34.2.127 Text en © The Korean Society for Laboratory Medicine. http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Kahng, Jimin Oh, Eun-Jee Lee, Hae Nam Lee, Dae Woo Kim, Yonggoo Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection |
title | Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection |
title_full | Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection |
title_fullStr | Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection |
title_full_unstemmed | Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection |
title_short | Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection |
title_sort | clinical validation of advansure genoblot assay as primary screening and test of cure for human papillomavirus infection |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3948825/ https://www.ncbi.nlm.nih.gov/pubmed/24624348 http://dx.doi.org/10.3343/alm.2014.34.2.127 |
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