Table 1.
Analysis using the BD Onclarity HPV assay of 35 specimens of FFPE tissues that previously tested negative for HPV by reference labs. A concordant result was observed for 33 specimens. Specimen 5 however was false-negative and specimen 31 resulted in a failure, leaving 33 true HPV negative specimens tested (specificity 100%). The specimens were tested in two separate cohorts, i.e. cohort 1 (specimens 1–15) and cohort 2 (specimens 16–35) (see methods for details).
| Sample number | Tissue tested | Tissue surface (mm2) | HPV type reference | HPV type BD Onclarity assay |
|---|---|---|---|---|
| 1 | Cheek biopsy | 3,9 | Negative | Negative |
| 2 | Cervix biopsy | 3,6 | Negative | Negative |
| 3 | Cervix biopsy | 72,7 | Negative | Negative |
| 4 | Labium minus skin biopsy | 17,2 | Negative | Negative |
| 5 | Cervix biopsy | 30,6 | Negativea | HPV18 |
| 6 | Vulvar biopsy | 14,9 | Negative | Negative |
| 7 | Bronchus biopsy (metastasis cervix carcinoma) | 11,1 | Negative | Negative |
| 8 | Tongue biopsy | 2,0 | Negative | Negative |
| 9 | Cervix excision | 21,2 | Negative | Negative |
| 10 | Cervix biopsy | 8,0 | Negative | Negative |
| 11 | Cervix biopsy | 231,3 | Negative | Negative |
| 12 | Vulvar biopsy | 3,7 | Negative | Negative |
| 13 | Cervix biopsy | 8,2 | Negative | Negative |
| 14 | Cervix biopsy | 23,6 | Negative | Negative |
| 15 | Tonsil biopsy | 14,7 | Negative | Negative |
| 16 | Liver biopsy | 12,2 | Negative | Negative |
| 17 | Oropharynx biopsy | 15,7 | Negative | Negative |
| 18 | Preputium resection | 185,3 | Negative | Negative |
| 19 | Vulva biopsy | 9,4 | Negative | Negative |
| 20 | Cervix biopsy | 29,6 | Negative | Negative |
| 21 | Cervix biopsy | 32,3 | Negative | Negative |
| 22 | Skin cheek biopsy | 7,9 | Negative | Negative |
| 23 | Vagina biopsy | 13,8 | Negative | Negative |
| 24 | Tongue biopsy | 21,8 | Negative | Negative |
| 25 | Neck biopsy | 15,5 | Negative | Negative |
| 26 | Tongue biopsy | 26,9 | Negative | Negative |
| 27 | Anus excision | 36,3 | Negative | Negative |
| 28 | Perineum biopsy | 7,9 | Negative | Negative |
| 29 | Mouth biopsy | 8,7 | Negative | Negative |
| 30 | Larynx biopsy | 5,3 | Negative | Negative |
| 31 | Neck biopsy | 9,2 | Negative | FAILURE |
| 32 | Pharynx biopsy | 12,4 | Negative | Negative |
| 33 | Oropharynx biopsy | 10,4 | Negative | Negative |
| 34 | Tongue excision | 13,8 | Negative | Negative |
| 35 | Oropharynx biopsy | 13,3 | Negative | Negative |
a
HPV18 positive when retested by another lab.