Table 2.
Summary of Performance Within High-Risk Human Papillomavirus (HR-HPV) RNA and DNA In Situ Hybridization (ISH) Methods for Viral Copies per Cell and Probe Manufacturer
| Performance Factor | No. of Responses | Correct No. (%) | P Valuea |
|---|---|---|---|
| RNA ISH | |||
| HR-HPV copies/cell | .23 | ||
| Negative for HR-HPV | 117 | 116 (99.1) | |
| 1–2 copies/cell | 126 | 120 (95.2) | |
| 50–100 copies/cell | 89 | 89 (100.0) | |
| 300–500 copies/cell | 130 | 125 (96.2) | |
| Probe manufacturerb | .42 | ||
| ACD | 272 | 270 (99.3) | |
| Ventana (RNA) | 158 | 149 (94.3) | |
| Other (RNA)b | 32 | 31 (96.9) | |
| DNA ISH | |||
| HR-HPV copies/cellc | <.001 | ||
| Negative for HR-HPV | 203 | 199 (98.0) | |
| 1–2 copies/cell | 240 | 129 (53.8) | |
| 50–100 copies/cell | 156 | 119 (76.3) | |
| 300–500 copies/cell | 207 | 203 (98.1) | |
| Probe manufacturerb | .47 | ||
| Enzo Biochem | 452 | 364 (80.5) | |
| Leica | 202 | 159 (78.7) | |
| Ventana (DNA) | 109 | 92 (84.4) | |
| Other (DNA)b | 39 | 32 (82.1) | |
Abbreviation: ACD, Advanced Cell Diagnostics.
Boldface indicates statistical significance.
“Other (RNA)” includes participants using RNA ISH who reported “Other” probe manufacturer. “Other (DNA)” includes Biocare Medical and participants using DNA ISH who reported “Other” probe manufacturer.
Negative for HR-HPV versus 1 to 2 copies/cell, P <.001. Negative for HR-HPV versus 50 to 100 copies/cell, P < .001; 1 to 2 copies/cell versus 50 to 100 copies/cell, P <.001; 1 to 2 copies/cell versus 300 to 500 copies/cell, P < .001; 50 to 100 copies/cell versus 300 to 500 copies/cell, P <.001.