Tsiodras et al. BMC Cancer 2010, 10:53 Page 4 of 8 http://www.biomedcentral.com/1471-2407/10/53 Table 2 ThinPrep diagnosis in relation to HPV DNA Table 3 Thin prep and HPV(+) testing by HC2 or PCR detection by HC2 or PCR versus biopsy HC2 WNL ASCUS LSIL HSIL SCC AdenoCa Total Biopsy results HC2 + 105 45 93 8 9 0 260 WNL CIN 1¶ CIN 2 CIN 3 SCC AdenoCa Negative 924 56 26 2 1 1 1010 ThinPrep Total Total 1029 101 119 10 10 1 1270 WNL (HPV 181 4 0 0 0 0 185 pos) # ASCUS 40 58 2 0 1 0 101 PCR WNL ASCUS LSIL HSIL SCC AdenoCa Total LSIL 0 117 2 0 0 0 119 HPV X 159 38 30 0 0 0 227 HSIL 0 0 7 3 0 0 10 HPV 6 10 4 9 1 0 0 24 SCC 0 0 0 0 10 0 10 HPV 11 0 13 13 1 0 0 27 AdenoCa 0 0 0 0 0 1 1 HPV 16 0 2§ 3 § 5§ 0 10 Total 221 179 11 3 11 1 426# HPV 18 0 8§ 5 § 1§ 1 15 HPV 31 1 1§ 2 § § 0 4 HPV test- WNL CIN 1¶ CIN 2 CIN 3 SCC AdenoCa Total HPV 33 10 § § § § 0 10 HC2 Multiple HPV types§ 5 20 43§ 8§ 4§ 0 80 HC2 + 104 137 8 2 9 0 260 PCR + 185 86 105 10 10 1 397 Negative 959 44 3 1 2 1 1010 Negative 844 15 14 0 0 0 873 Total 1063 181 11 3 11 1 1270 Total 1029 101 119 10 10 1 1270 Abbreviations: HC2: Hybrid Capture 2; HPV: Human Papillomavirus; WNL: (+) HPV WNL CIN 1 CIN 2 CIN 3 SCC AdenoCa Total Within Normal Limits; Hyperk: Hyperkeratosis; ASCUS: Atypical Squamous Cells test-PCR of Undetermined Significance; LSIL: Low-grade Squamous Intraepithelial Lesion; HPV X 180 46 1 0 0 0 227 HSIL: High-grade Squamous Intraepithelial Lesion; SCC: Squamous Cell HPV 6 10 12 2 0 0 0 24 Carcinoma; AdenoCa: Adenococarcinoma HPV 11 1 24 2 0 0 0 27 §Denotes the presence of mixed infections that are summarized under multiple HPV types. Nine HPV 16 mixed infections had LSIL, six had HSIL and HPV 16 0 4 (3*) (3*) 6 (4*) 0 10 four SCC. Twenty-seven HPV 18 mixed infections had LSIL, five had HSIL and three SCC. Nine HPV 31 mixed infections had LSIL, one had HSIL and two SCC. HPV 18 0 13 (6*) 0 1 (3*) 1 15 Seven HPV 33 mixed infections had LSIL, two had HSIL and three SCC. HPV 31 0 4 (1*) (1*) (2*) 0 4 HPV 33 10 0 (1*) (1*) (3*) 0 10 (60%) for HC2 and PCR respectively; for HSIL 6/10 Multiple 7 60 6 3 4 0 80 HPV types (60%) by HC2 and 8/10 (80%) by PCR (Table 2). All PCR (-) 855 18 0 0 0 0 873 cytological diagnoses (10/10) of squamous cell carcino- Total 1063 181 11 3 11 1 1270 mas tested positive for at least one of the high risk oncogenic HPV types 16, 18, 31, or 33 by PCR # Data on 844 women with Thin test within normal limits and no HPV detection or colposcopic lesion that did not undergo biopsy are not shown. (Table 2). ¶2 Two women had a colposcopic lesion that on biopsy was CIN 1, with normal pap and no HPV Histological results * Denotes the presence of mixed infections that are summarized under multiple HPV types. All multiple infections associated with > = CIN2 had The comparison of ThinPrep diagnoses and histological either HPV 16, 18, 31, 33. results is presented at Table 3. In total, 426 women underwent biopsy (Table 3). From patients with ASCUS 58 out of 101 (57.4%) had CIN 1 in biopsy, whereas viruses, whereas PCR detected HPV types 16, 18, 31, or only 3 (3%) patients had CIN 2 or higher-grade lesions 33 in 21/26 (80.8%) such cases (Table 3). For CIN 3 and (Table 3). Only two of 119 (1.7%) patients with LSIL invasive carcinoma, HC2 was positive in 11/15 (73.3%), had CIN 2. All (100%) cases classified as HSIL with whereas high risk HPV types by PCR were detected in ThinPrep cytology had a biopsy diagnosis of either 15/15 cases (100%) (Table 3). Seven of the 11 (63.6%) CIN2 or CIN 3. ThinPrep cytology correctly identified squamous cell carcinoma cases confirmed by biopsy had the single case with cervical adenocarcinoma as well as a single infection with either HPV type 16 or 18. The 10 of 11 (90.9%) subjects with a histological diagnosis of single adenocarcinoma case had an infection with HPV SCC (Table 3). One patient diagnosed cytologically as type 18 only. Four mixed infections (all had HPV 16, ASCUS had a SCC on subsequent biopsy. three HPV 18 or HPV 33 and two HPV 31) were diag- Nineteen out of 26 cases (73.1%) with a biopsy diag- nosed by biopsy as SCC. Sensitivities, specificities, posi- nosis of CIN 2+ had a HC2 positive test for high risk tive and negative predictive values and positive and