Baseline positivity of anal cytology and biomarkers by histologic anal diagnosis.

<p>P values correspond to a comparison of the proportion of subjects with no SIL or LSIL versus those with HSIL, who were identified by each biomarker.</p><p>SIL, squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion; HSIL, high-grade squamous intraepithelial lesion; HPV, human papillomavirus.</p><p>LSIL group included MSM with anal intraepithelial neoplasia (AIN) 1 on histology. HSIL group included MSM with AIN 2 or AIN 3 on histology. No SIL group included MSM without LSIL or HSIL.</p

Baseline positive and persistent positive biomarkers predicting incident anal histologic HSIL at subsequent visits among those who were free of disease at baseline.

<p>HSIL, high-grade squamous intraepithelial lesion; HPV, human papillomavirus; CI, confidence interval.</p><p>HSIL included anal intraepithelial neoplasia (AIN) 2 or AIN 3 on histology.</p>a<p>High-risk HPV DNA included HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68.</p>b<p>E6/E7 mRNA positivity was defined as greater than or equal to 2% of cells which had E6/E7 mRNA over-expression in the sample.</p>c<p>p16 immunocytochemistry was considered positive if there was a presence of cells with cytoplasmic and/or nuclear staining.</p>d<p>Multivariate model adjusted for HIV status and low-grade squamous intraepithelial lesion at baseline.</p

Performance characteristics of anal cytology, high-risk HPV DNA, HPV E6/E7 mRNA, and p16 immunocytochemistry to detect anal histologic HSIL at baseline, by HIV status.

<p>HSIL, high-grade squamous intraepithelial lesion; CI, confidence interval; PPV, positive predictive value; NPV, negative predictive value; AROC, area under the receiver operator characteristics curve; HPV, human papillomavirus.</p><p>HSIL included anal intraepithelial neoplasia (AIN) 2 or AIN 3 on histology.</p>a<p>High-risk HPV DNA included HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68.</p>b<p>E6/E7 mRNA positivity was defined as greater than or equal to 2% of cells which had E6/E7 mRNA over-expression in the sample.</p>c<p>p16 immunocytochemistry was considered positive if there was a presence of cells with cytoplasmic and/or nuclear staining.</p>d<p>*P≤0.05 and ‡ P≤0.001 in pairwise comparisons against anal cytology, in subjects with HSIL for sensitivity and subjects without HSIL for specificity.</p>e<p>P values for pairwise comparisons of the AROC relative to anal cytology as a reference group.</p

Receiver operator characteristics plots of biomarker performances to detect anal histologic HSIL.

<p>(A) Performance characteristics of anal cytology, high-risk HPV DNA, HPV 16 and/or 18, E6/E7 mRNA, and p16 immunocytochemistry, when each test was used alone to detect HSIL. (B) Performance characteristics when tests were used in combination to detect HSIL. HSIL, high-grade squamous intraepithelial lesion. HSIL included anal intraepithelial neoplasia (AIN) 2 or AIN 3 on histology.</p