Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection.
10.3343/alm.2014.34.2.127
- Author:
Jimin KAHNG
1
;
Eun Jee OH
;
Hae Nam LEE
;
Dae Woo LEE
;
Yonggoo KIM
Author Information
1. Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. yonggoo@catholic.ac.kr
- Publication Type:Original Article ; Comparative Study ; Evaluation Studies
- Keywords:
HPV;
Genotype;
Cervical cancer;
Screening;
Clinical validation;
Test of cure
- MeSH:
Adolescent;
Adult;
Aged;
*Blotting, Southern;
DNA, Viral/*analysis;
Female;
Genotype;
Humans;
Middle Aged;
Papillomaviridae/*genetics;
Papillomavirus Infections/*diagnosis/pathology/therapy;
Reagent Kits, Diagnostic;
*Real-Time Polymerase Chain Reaction;
Sequence Analysis, DNA;
Young Adult
- From:Annals of Laboratory Medicine
2014;34(2):127-133
- CountryRepublic of Korea
- Language:English
-
Abstract:
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.
