Evaluation of alternately combining HPV viral load and 16/18 genotyping in secondary screening algorithms

• Published in: PloS one Vol. 14; no. 7; p. e0220200
• Main Authors: Luo, Hongxue, Du, Hui, Belinson, Jerome L., Wu, Ruifang
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 26.07.2019; Public Library of Science (PLoS)
• Subjects: Adult; Algorithms; Antiretroviral drugs; Biology and Life Sciences; Biomarkers; Cancer; Cancer screening; Cellular biology; Cervical cancer; Cervical Intraepithelial Neoplasia - virology; Cervix dysplasia; Colposcopy; Cytology; Diagnosis; DNA, Viral - analysis; Feasibility Studies; Female; Genetic aspects; Genotyping; Genotyping Techniques; Gynecology; Health screening; Human papillomavirus; Human papillomavirus 16 - genetics; Human papillomavirus 16 - physiology; Human papillomavirus 18 - genetics; Human papillomavirus 18 - physiology; Humans; Ionization; Ions; Laboratories; Laser arrays; Lesions; Load distribution; Mass spectrometry; Mass spectroscopy; Medical screening; Medicine and Health Sciences; Middle Aged; Obstetrics; Oncology; Papillomavirus; Papillomavirus infections; Papillomavirus Infections - diagnosis; Physical Sciences; Research and Analysis Methods; Risk factors; Scientific imaging; Sensitivity; Sensitivity and Specificity; Spectroscopy; Strategy; Triage; Viral Load; Womens health; United States > US; China; Ohio
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0220200

Correlation with HPV viral load and worsening cervical lesions had been reported, but its potential for triage after primary HPV screening has not been adequately explored, especially when combined with HPV-16/18 genotyping. To evaluate combinations of human papillomavirus (HPV) viral load and genotyping for HPV-16/18 as secondary screening strategies. The Shenzhen Cervical Cancer Screening Trial Ⅱ (SHENCCAST Ⅱ) database was re-analyzed to explore new screening algorithms using the results of Hybrid Capture 2 (HC2), Mass Array Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass spectrometry System (MALDI-TOF-MS) and the ThinPrep cytologic test (TCT) obtained by endocervical sampling. Compared with the recommended screening strategy of genotyping HPV-16/18 plus reflex to cytology, using viral load (10 RLU/CO as threshold) plus reflex to cytology resulted in less cytology but had a significantly higher sensitivity for cervical intraepithelial neoplasia 2+ (CIN2+)/CIN3+ without considerable changes in specificity and referral rates. Both of the strategy of using viral load ≥10 RLU/CO as cut-point for immediate colposcopy followed by triage genotyping HPV-16/18 for the other positive (≥1<10 RLU/CO) and the strategy of referring HPV-16/18 positives for immediate colposcopy followed by triage viral load (10 RLU/CO as threshold) for non-HPV-16/18 positives had comparable screening efficacy with algorithims that contain cytology. Primary HPV screening with triage of HPV-positive women by a combination of viral load and genotyping for HPV-16/18 provides good balance between sensitivity and specificity, the number of tests required, and referral rates.