Table 2.
Analysis using the BD Onclarity HPV assay of 41 specimens of FFPE tissues that previously tested positive for HPV by reference labs. A fully concordant positive result was observed for a total of 38/41 specimens, (sensitivity 93%). The specimens were tested in two separate cohorts, i.e. cohort 1 (specimens 1–22) and cohort 2 (specimens 23–41) (see methods for details).
| Sample number | Tissue tested | Tissue surface (mm2) | HPV type reference | HPV type BD Onclarity HPV assay |
|---|---|---|---|---|
| 1 | Uterus cervix extirpation | 203,9 | HPV16 | HPV16 |
| 2 | Larynx biopsy | 97,5 | HPV16 | HPV16 |
| 3 | Cervix biopsy | 36,1 | HPV16 | HPV16 |
| 4 | Lung biopy (metastasis cervix carcinoma) | 32,0 | HPV18 | HPV18 |
| 5 | Lymph node excision (metastasis SCC, primary unknown) | 82,7 | HPV16 | HPV16 |
| 6 | Cervix excision | 88,6 | HPV45 | Negative |
| 7 | Tonsil biopsy | 21,6 | HPV18 | HPV18 |
| 8 | Cervix biopsy | 58,6 | HPV18 | HPV18 |
| 9 | Tonsil biopsy | 69,1 | HPV16 | HPV16 |
| 10 | Cervix biopsy | 52,5 | HPV16 | HPV16 |
| 11 | Vaginal biopsy | 15,8 | HPV45 | HPV45 |
| 12 | Cervix biopsy | 45,4 | HPV45 | HPV45 |
| 13 | Cervix biopsy | 109,6 | HPV18 | HPV18 |
| 14 | Cervix loop excision | 98,8 | HPV18 | HPV18 |
| 15 | Cervix loop excision | 67,0 | HPV59 | P2 (56/59/66) |
| 16 | Cervix biopsy | 32,3 | HPV16 | HPV16 |
| 17 | Endometrial curettage | 160,8 | HPV16 | HPV16 |
| 18 | Cervix curettage | 278,5 | HPV16 | HPV16 |
| 19 | Cervix loop excision | 149,9 | HPV16 | HPV16 |
| 20 | Cervix biopsy | 14,6 | HPV16 | HPV16 |
| 21 | Cervix resection | 490,0 | HPV16 | HPV16 |
| 22 | Cervix loop excision | 153,0 | HPV16 | HPV16 |
| 23 | Skin penis biopsy | 6,9 | HPV16, HPV31 | HPV16, HPV31 |
| 24 | Cervix biopsy | 18,5 | HPV18 | HPV18 |
| 25 | Cervix curretage | 35 | HPV18 | HPV18 |
| 26 | Tonsil biopsy | 86,1 | HPV33 | P1 (33/58) |
| 27 | Cervix loop excision | 144,1 | HPV18 | HPV18 |
| 28 | Cervix excision | 119,4 | HPV18 | HPV18 |
| 29 | Anus biopsy | 63,6 | HPV33 | P1 (33/58) |
| 30 | Cervix biopsy | 12,9 | HPV18 | HPV18 |
| 31 | Tonsil biopsy | 24,9 | HPV33 | P1 (33/58) |
| 32 | Vulva excision | 101,5 | HPV16, HPV56 | HPV16 |
| 33 | Mouth biopsy | 15,7 | HPV35 | P3 (35/39/68) |
| 34 | Anus excision | 158,6 | HPV52 | HPV52 |
| 35 | Oropharynx biopsy | 23,5 | HPV33 | P1 (33/58) |
| 36 | Palatum molle biopsy | 23,1 | HPV33 | P1 (33/58) |
| 37 | Neck excision | 51,2 | HPV59 | P2 (56/59/66) |
| 38 | Cervix biopsy | 29,6 | HPV18 | HPV18 |
| 39 | Cervix biopsy | 46,5 | HPV31 | HPV31 |
| 40 | Rectum biopsy | 12,3 | HPV18, HPV52 | HPV18, HPV52 |
| 41 | Mons pubis biopsy | 110,2 | HPV52 | Negative |