Table 2.

Biomarker Performance Characteristics for Baseline Detection of High-grade Squamous Intraepithelial Lesion/Anal Intraepithelial Neoplasia Grades 2 and 3, Overall and by Age Group

Biomarker (% positive)	<HSIL/AIN2 (n)	HSIL/AIN2+ (n)	Sensitivity (%)	Specificity (%)
HR-HPV (79.1)	255	104	100.0	29.4
<50 years (86.9)	102	43	100.0	18.6
≥50 years (73.8)	149	61	100.0	36.9
HPV16/18 (38.4)	255	104	64.4	72.2
<50 years (44.1)	102	43	67.4	65.7
≥50 years (34.8)	149	61	62.3	76.5
Dual staina (69.0)	229	103	93.2	41.9
<50 years (77.1)	97	43	97.7	32.0
≥50 years (63.0)	129	60	90.0	49.6
HPV E6/E7 mRNA (47.5)	255	103	79.6	65.5
<50 years (55.6)	101	43	83.7	56.4
≥50 years (41.9)	150	60	76.7	72.0
Cytologyc (67.0)	237	102	91.2	43.5
<50 years (70.1)	95	42	95.2	41.1
≥50 years (64.7)	138	60	88.3	45.7
Biomarker combinations b
Dual stain or HPV16/18 (75.5)	239	104	96.2	33.5
<50 years (83.0)	98	43	100.0	24.5
≥50 years (70.2)	137	61	93.4	40.2
Dual stain and HPV16/18 (31.0)	245	103	60.0	83.8
<50 years (38.2)	101	43	65.1	73.3
≥50 years (26.4)	141	60	58.3	87.2
Dual stain or E6/E7 mRNA (74.8)	233	104	96.2	34.8
<50 years (81.3)	96	43	100.0	27.1
≥50 years (70.1)	133	61	93.4	40.6
Dual stain and E6/E7 mRNA (41.6)	251	102	76.5	72.5
<50 years (51.7)	102	43	81.4	60.8
≥50 years (34.6)	146	59	72.9	80.8
HPV16/18 or E6/67 mRNA (55.2)	253	104	85.6	57.3
<50 years (62.5)	101	43	88.4	48.5
≥50 years (50.2)	148	61	83.6	63.5

Counts may not sum to 363 due to missing biomarker data.

Abbreviations: AIN2, anal intraepithelial neoplasia grade 2; AIN2+, anal intraepithelial neoplasia grades 2 and 3; ASC-US+, atypical cells of undetermined significance or more severe cytology; HPV, human papillomavirus; HR-HPV, high-risk HPV; HSIL, high-grade squamous intraepithelial lesion; mRNA, messenger RNA.

^aThe threshold for a p16/Ki-67 dual stain was 1 positive cell.

^bBiomarkers can either be combined as positive for at least 1 (ie, “or”) or positive for both (ie, “and”).

^cThe threshold for cytology was ASC-US+.