Table 2.
Sensitivity and specificity of oncogenic HPV biomarkers in oral exfoliated cells or serum for HPV-related OPC
| n/N (%) | ||
|---|---|---|
| Sensitivity for HPV-positive OPC | Specificity for noncancer "controls"b | |
| Oral rinse HPV | ||
| HPV16 | ||
| SPF10 DEIA | 68/133 (51%) | 422/428 (99%) |
| Cobas DNA | 50/117 (43%) | 410/417 (98%) |
| Any oncogenic typea | ||
| SPF10 DEIA | 80/133 (60%) | 415/428 (97%) |
| Cobas DNA | 57/117 (49%) | 403/417 (97%) |
| Aptima RNA | 23/100 (23%) | 394/396 (99%) |
| HPV serum antibodies | ||
| HPV16 | ||
| E1 antibody | 61/89 (69%) | 212/217 (98%) |
| E2 antibody | 69/89 (78%) | 216/217 (100%) |
| E6 antibody | 78/89 (88%) | 213/217 (98%) |
| E7 antibody | 67/89 (75%) | 206/217 (95%) |
| Any oncogenic typea | ||
| E6 antibody | 82/89 (92%) | 201/217 (93%) |
| E7 antibody | 69/89 (78%) | 201/217 (93%) |
| Cotesting | ||
| Cotesting by HPV16 oral rinse DNA and serum antibodies: | ||
| BOTH: HPV16 DEIA and E6 antibody | 43/89 (48%) | 217/217 (100%) |
| BOTH: HPV16 Cobas and E6 antibody | 29/79 (37%) | 214/214 (100%) |
| EITHER: HPV16 DEIA and/or E6 antibody | 81/89 (91%) | 210/217 (97%) |
| EITHER: HPV16 Cobas and/or E6 antibody | 72/79 (91%) | 206/214 (96%) |
| Cotesting with multiple HPV16 E6 serum antibodies: | ||
| BOTH: HPV16E6 and E7 antibodies | 61/89 (69%) | 217/217 (100%) |
| ≥3 of these 4: HPV16 E1, E2, E6, E7 | 64/89 (72%) | 217/217 (100%) |
| EITHER: HPV16 E6 and/or E7 antibodies | 84/89 (94%) | 202/217 (93%) |
| ANY OF: HPV16 E1, E2, E6, and/or E7 | 85/89 (96%) | 197/217 (91%) |
| Cotesting with multiple OncHPV E6 serum antibodies: | ||
| BOTH: OncHPV E6 and E7 antibodies | 65/89 (73%) | 215/217 (99%) |
| EITHER: OncHPV E6 and/or E7 antibodies | 86/89 (97%) | 187/217 (86%) |
Oral rinse and serum included these 8 oncogenic HPV types: 16, 18, 31, 33, 35, 45, 52, 58; In addition, oral rinse (but not serum) test also included in oncogenic definition these 6 types: 39, 51, 56, 59, 66, (and type 68 for Cobas and Aptima but not DEIA).
The non-cancer "control" group included HOTSPOT controls and individuals from the MOUTH screening study (see columns 2 and 3 in Supplementary Table S1; The high-risk group (MACS WIHS CCS) were not included in this comparison group given the non-representative nature of this population. Results were similar when using only the 134 HOTSPOT noncancer controls (excluding the MOUTH screening) as the negative reference group, with a specificity of: 100% (oncogenic SPF10-DEIA 134/134); 100% (Cobas 124/124); 99.0% (Aptima 101/102); and 95.6% (43/45 HPV16 E6 and/or E7 seropositive).