Clinical validation of AdvanSure GenoBlot assay as primary screening and test of cure for human papillomavirus infection.

Jimin Kahng, Eun-Jee Oh, Hae Nam Lee, Dae Woo Lee, Yonggoo Kim

Index: Ann. Lab. Med. 34(2) , 127-33, (2014)

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Abstract

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).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.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.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.