Table 3.
Concordance Between RDLA and E1 Assay for Detection of Vaccine and Non-Vaccine HPV Types by Case Status and Race
| HPV Groups | Race | Case Status | Number of Study Participants | HR-HPV Results (RDLA/E1) | Crude Concordance | Gwet’s AC1 Agreement | |||
|---|---|---|---|---|---|---|---|---|---|
| +/+ | -/- | +/- | -/+ | ||||||
| Any HR-HPV | AA | ≤ CIN 1 | 180 | 89 | 42 | 37 | 12 | 0.73 (0.66–0.79) | 0.49 (0.36–0.62) |
| CA | ≤ CIN 1 | 176 | 87 | 51 | 31 | 7 | 0.78 (0.72–0.85) | 0.59 (0.46–0.71) | |
| AA | CIN 2+ | 77 | 63 | 0 | 12 | 2 | 0.82 (0.73–0.91) | 0.78 (0.66–0.91) | |
| CA | CIN 2+ | 90 | 77 | 5 | 6 | 2 | 0.91 (0.85–0.97) | 0.89 (0.81–0.97) | |
| Positive for HPV 16 or 18 | AA | ≤ CIN 1 | 72 | 14 | 42 | 4 | 12 | 0.78 (0.68–0.88) | 0.61 (0.43–0.80) |
| CA | ≤ CIN 1 | 93 | 27 | 51 | 8 | 7 | 0.84 (0.76–0.91) | 0.70 (0.55–0.85) | |
| AA | CIN 2+ | 15 | 9 | 0 | 4 | 2 | 0.60 (0.33–0.87) | 0.41 (−0.13–0.95) | |
| CA | CIN 2+ | 32 | 24 | 5 | 1 | 2 | 0.91 (0.80–1.0) | 0.86 (0.70–1.0) | |
| HPV 16 or 18 negative | AA | ≤ CIN 1 | 134 | 50 | 42 | 30 | 12 | 0.69 (0.61–0.77) | 0.38 (0.22–0.53) |
| CA | ≤ CIN 1 | 118 | 37 | 51 | 23 | 7 | 0.74 (0.65–0.83) | 0.48 (0.29–0.66) | |
| AA | CIN 2+ | 45 | 37 | 0 | 6 | 2 | 0.82 (0.71–0.94) | 0.79 (0.63–0.95) | |
| CA | CIN 2+ | 36 | 25 | 5 | 4 | 2 | 0.83 (0.71–0.96) | 0.75 (0.53–0.96) | |
| Positive for HR-HPV types included in 9VHPV vaccines | AA | ≤ CIN 1 | 113 | 39 | 42 | 20 | 12 | 0.72 (0.63–0.80) | 0.43 (0.27–0.60) |
| CA | ≤ CIN 1 | 133 | 56 | 51 | 19 | 7 | 0.75 (0.67–0.83) | 0.50 (0.34–0.66) | |
| AA | CIN 2+ | 45 | 32 | 0 | 11 | 2 | 0.71 (0.58–0.85) | 0.62 (0.39–0.85) | |
| CA | CIN 2+ | 50 | 40 | 5 | 3 | 2 | 0.90 (0.82–0.99) | 0.87 (0.74–0.99) | |
| Negative for HR-HPV types included in 9V HPV vaccines | AA | ≤ CIN 1 | 80 | 20 | 42 | 6 | 12 | 0.78 (0.68–0.87) | 0.58 (0.40–0.77) |
| CA | ≤ CIN 1 | 80 | 12 | 51 | 10 | 7 | 0.79 (0.70–0.88) | 0.66 (0.49–0.82) | |
| AA | CIN 2+ | 15 | 13 | 0 | 0 | 2 | 0.87 (0.68–1.0) | 0.85 (0.60–1.0) | |
| CA | CIN 2+ | 21 | 11 | 5 | 3 | 2 | 0.76 (0.57–0.96) | 0.56 (0.18–0.95) | |
Notes: Degree of agreement categorization <0-no agreement, 0.01–0.2 slight agreement, 0.21–0.40 fair agreement, 0.41–0.60 moderate agreement, 0.61 to 0.80 substantial agreement and 0.8–1.0 almost perfect agreement.
Abbreviations: RDLA, Roche Diagnostics Linear Array; HR-HPV, high-risk human papillomavirus; AA, African American; CA, Caucasian American; CIN 1, 2, 3, cervical intraepithelial neoplasia grades.