Validity of Mehrviru® and Sacace® in molecular detection of HPV: a latent class analysis.

Abstract

Background: Valid diagnostic tests for human papillomavirus (HPV) detection are crucial to identify individuals at high risk of cervical cancer. We assessed and compared the validity of Mehrviru HPV genotyping and Sacace (HPV Genotypes 14 Real-TM Quant) for molecular detection of 14 high-risk human papillomaviruses.

Methods: We used three HPV test results to identify HPV-positive individuals (14 high-risk genotypes) in a specialist gynecology clinic. The HPV test results were collected using Mehrviru^®, Sacace^®, and a third kit from the clinical diagnostic laboratory. We used Latent class analysis to determine the actual status of HPV infection in study participants. The sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios, Youden, and area under the ROC curve indices of each diagnostic kit and their 95% confidence intervals were calculated. The agreement between the Mehrviru and Sacace kits was determined using the Kappa statistic.

Results: We examined 117 women at high risk of HPV infection. The mean age (SD) was 37.2 (9.1). According to LCA, 28.6% of participants had an HPV infection. The sensitivity and specificity (95% CI) of the Mehrviru were 90.8% (73.7-97.2%) and 90.9% (82.1-95.6%), and corresponding figures for Sacace were 92.0% (72.3-98.1%) and 97.4% (90.2-99.3%). The kappa index between the Mehrviru and Sacace kits was 69.7% (55.6-83.9%). The area under the ROC curve for Mehrviru and Sacace test were 91.4% (85.7-97.1%) and 94.4% (89.3-99.5%).

Conclusions: There is an excellent agreement between Mehrviru and Sacace test results, and the diagnostic accuracy indices were similar.