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Detection of Human Papillomavirus Genotypes Among High-Risk Women: A Comparison of Hybrid Capture and Linear Array Tests

Monsonego, Joseph MD*; Pollini, Giuseppe MD*; Evrard, Marie José MSc*; Sednaoui, Patrice MD*; Monfort, Laura MD*; Zerat, Laurent MD; Syrjänen, Kari MD, PhD, FIAC

Sexually Transmitted Diseases: May 2008 - Volume 35 - Issue 5 - p 521-527
doi: 10.1097/OLQ.0b013e318164e567
Articles

Objectives: To assess the concordance and performance of 2 different assays in detection of human papillomavirus (HPV) genotypes among women with abnormal Pap smear.

Study Design: A series of 575 women referred for colposcopy due to an abnormal Pap smear were analyzed with the Linear Array HPV Genotyping test detecting 37 HPV types and compared with Hybrid Capture II (HCII) assay for detection of carcinogenic HPV. Histologic outcomes of cervical intraepithelial neoplasia grade 2 (CIN2) or worse (CIN2+) and CIN3+ were the primary endpoints. Clinical performance, including receiver operating characteristics, was determined for both tests.

Results: HCII and linear array (LA) were concordant in 88.1% (433/491; 95% CI 85.3%–91.0%), having a substantial agreement with regular κ (κ = 0.70, 95% CI 0.62–0.77) and almost perfect agreement with weighted κ (ICC = 0.82, 95% CI 0.7–0.85). In detecting CIN2+ and CIN3+, LA is 5% and 6% more sensitive but 9.5% and 8.7% less specific than HCII (area under ROC curve; P = 0.317 and P = 0.875, respectively).

Conclusions: Performance of HCII and LA does not significantly differ in detecting CIN2+ or CIN3+.

In detecting CIN2+ and CIN3+, LA is 5% and 6% more sensitive but 9.5% and 8.7% less specific than HCII (AUC; P = 0.317 and P = 0.875, respectively), i.e., not significantly different.

From the *Institut Alfred Fournier Paris, France; †Laboratoire Lavergne, Paris; and ‡Department of Oncology and Radiotherapy, Turku University Hospital, Savitehtaankatu 1, Turku, Finland

This study has been supported by a research grant from Roche Molecular Systems (France), kindly donating the Linear Array at our disposal.

Correspondence: Dr. Joseph Monsonego, MD, 174 rue de Courcelles, 75017 Paris, France. E-mail: jm@eurogin.com.

Received for publication October 22, 2007, and accepted December 4, 2007.

© Copyright 2008 American Sexually Transmitted Diseases Association