Table 3.
Comparison of Results (in Quartiles) to the SEAP Pseudovirion Neutralization Assay for HPV-16/18 (Gold Standard) by Dose Groups.
| Assay | HPV Type | Total N | % Exact Agreement (95% CI) | Pearson correlation (95% CI) | Weighted Kappa (95% CI) | Symmetry p-value |
|---|---|---|---|---|---|---|
| HPV-16 ASSAYS | ||||||
| SAMPLES FROM SINGLE DOSE RECIPIENTS | ||||||
| ELISA | 16 | 170 | 78.8% (72.2%−84.5%) | 0.85 (0.81–0.89) | 0.69 (0.60–0.79) | 0.78 |
| LIA-4 | 16 | 170 | 80.6% (74.1%−86.0%) | 0.81 (0.75–0.86) | 0.71 (0.63–0.80) | 0.87 |
| VLP-MIA | 16 | 153 | 53.6% (45.7%−61.4%) | 0.43 (0.29–0.55) | 0.34 (0.26–0.42) | <0.001 |
| M9E | 16 | 167 | 81.4% (75.0%−86.8%) | 0.75 (0.67–0.81) | 0.72 (0.64–0.81) | 0.82 |
| GST-L1 | 16 | 170 | 77.6% (70.9%−83.4%) | 0.75 (0.67–0.81) | 0.68 (0.59–0.78) | 0.64 |
| HT-PBNA | 16 | 170 | 87.1% (81.4%−91.5%) | 0.84 (0.79–0.88) | 0.82 (0.75–0.90) | 1.00 |
| SAMPLES FROM REDUCED DOSE RECIPIENTS | ||||||
| ELISA | 16 | 170 | 68.2% (61.0%−74.9%) | 0.63 (0.53–0.71) | 0.65 (0.56–0.73) | 0.55 |
| LIA-4 | 16 | 170 | 66.5% (59.1%−73.3%) | 0.71 (0.63–0.78) | 0.63 (0.54–0.71) | 0.15 |
| VLP-MIA | 16 | 102 | 29.4% (21.2%−38.8%) | 0.17 (−0.03–0.35) | 0.23 (0.13–0.33) | <0.001 |
| M9E | 16 | 167 | 70.7% (63.4%−77.2%) | 0.82 (0.77–0.87) | 0.68 (0.60–0.76) | 0.54 |
| GST-L1 | 16 | 170 | 49.4% (41.9%−56.9%) | 0.41 (0.28–0.53) | 0.47 (0.38–0.56) | 0.60 |
| HT-PBNA | 16 | 170 | 74.1% (67.1%−80.3%) | 0.89 (0.85–0.91) | 0.73 (0.66–0.80) | 0.72 |
| SAMPLES FROM FULL DOSE RECIPIENTS | ||||||
| ELISA | 16 | 170 | 80.0% (73.5%−85.5%) | 0.90 (0.87–0.93) | 0.74 (0.66–0.82) | 0.74 |
| LIA-4 | 16 | 170 | 85.9% (80.0%−90.5%) | 0.92 (0.89–0.94) | 0.82 (0.75–0.89) | 0.38 |
| VLP-MIA | 16 | 52 | 50.0% (36.6%−63.4%) | 0.55 (0.33–0.72) | 0.41 (0.24–0.58) | 0.0010 |
| M9E | 16 | 168 | 86.3% (80.5%−90.9%) | 0.91 (0.88–0.93) | 0.83 (0.76–0.89) | 0.56 |
| GST-L1 | 16 | 169 | 58.0% (50.4%−65.3%) | 0.45 (0.33–0.57) | 0.48 (0.37–0.58) | 0.50 |
| HT-PBNA | 16 | 170 | 82.9% (76.7%−88.0%) | 0.92 (0.89–0.94) | 0.77 (0.70–0.85) | 0.46 |
| ALL SAMPLES REGARDLESS OF NUMBER OF DOSES | ||||||
| ELISA | 16 | 510 | 75.7% (71.8%−79.3%) | 0.87 (0.84–0.89) | 0.79 (0.76–0.83) | 0.95 |
| LIA-4 | 16 | 510 | 77.6% (73.9%−81.1%) | 0.89 (0.87–0.90) | 0.81 (0.78–0.84) | 0.95 |
| VLP-MIA | 16 | 307 | 45.0% (39.4%−50.6%) | 0.51 (0.42–0.59) | 0.45 (0.40–0.51) | <0.001 |
| M9E | 16 | 502 | 79.5% (75.8%−82.8%) | 0.89 (0.87–0.91) | 0.83 (0.80–0.86) | 1.00 |
| GST-L1 | 16 | 509 | 61.7% (57.4%−65.8%) | 0.55 (0.48–0.60) | 0.67 (0.63–0.71) | 0.57 |
| HT-PBNA | 16 | 510 | 81.4% (77.8%−84.6%) | 0.90 (0.88–0.92) | 0.84 (0.81–0.87) | 0.54 |
| HPV-18 ASSAYS | ||||||
| SAMPLES FROM SINGLE DOSE RECIPIENTS | ||||||
| ELISA | 18 | 170 | 69.4% (62.2%−76.0%) | 0.95 (0.93–0.96) | 0.63 (0.53–0.72) | 0.92 |
| LIA-4 | 18 | 170 | 78.2% (71.6%−84.0%) | 0.99 (0.98–0.99) | 0.74 (0.66–0.82) | 0.71 |
| VLP-MIA | 18 | 166 | 71.1% (63.8%−77.6%) | 0.42 (0.29–0.54) | 0.64 (0.55–0.74) | 0.51 |
| M9E | 18 | 167 | 80.8% (74.3%−86.3%) | 0.97 (0.96–0.98) | 0.78 (0.70–0.85) | 0.54 |
| GST-L1 | 18 | 170 | 50.6% (43.1%−58.1%) | 0.31 (0.16–0.44) | 0.35 (0.24–0.47) | 0.18 |
| HT-PBNA | 18 | 170 | 84.7% (78.7%−89.5%) | 0.95 (0.94–0.97) | 0.83 (0.76–0.89) | 0.88 |
| SAMPLES FROM REDUCED DOSE RECIPIENTS | ||||||
| ELISA | 18 | 170 | 70.6% (63.4%−77.1%) | 0.85 (0.80–0.89) | 0.72 (0.65–0.79) | 0.76 |
| LIA-4 | 18 | 170 | 76.5% (69.7%−82.4%) | 0.89 (0.85–0.92) | 0.78 (0.72–0.85) | 0.80 |
| VLP-MIA | 18 | 160 | 59.4% (51.6%−66.8%) | 0.36 (0.22–0.49) | 0.62 (0.54–0.70) | 0.026 |
| M9E | 18 | 167 | 74.3% (67.2%−80.5%) | 0.89 (0.86–0.92) | 0.76 (0.70–0.83) | 0.84 |
| GST-L1 | 18 | 170 | 36.5% (29.5%−43.9%) | 0.41 (0.27–0.53) | 0.26 (0.15–0.37) | 0.85 |
| HT-PBNA | 18 | 170 | 76.5% (69.7%−82.4%) | 0.93 (0.91–0.95) | 0.78 (0.71–0.84) | 0.68 |
| SAMPLES FROM FULL DOSE RECIPIENTS | ||||||
| ELISA | 18 | 170 | 82.9% (76.7%−88.0%) | 0.97 (0.95–0.97) | 0.81 (0.74–0.88) | 0.80 |
| LIA-4 | 18 | 170 | 82.4% (76.1%−87.5%) | 0.93 (0.91–0.95) | 0.80 (0.74–0.87) | 0.64 |
| VLP-MIA | 18 | 145 | 74.5% (66.9%−81.1%) | 0.23 (0.07–0.38) | 0.72 (0.63–0.81) | 0.30 |
| M9E | 18 | 168 | 82.7% (76.5%−87.9%) | 0.95 (0.94–0.97) | 0.81 (0.75–0.88) | 0.73 |
| GST-L1 | 18 | 169 | 52.1% (44.5%−59.5%) | 0.43 (0.30–0.55) | 0.41 (0.30–0.52) | 0.016 |
| HT-PBNA | 18 | 170 | 81.8% (75.4%−87.0%) | 0.97 (0.96–0.98) | 0.80 (0.73–0.87) | 0.48 |
| ALL SAMPLES REGARDLESS OF NUMBER OF DOSES | ||||||
| ELISA | 18 | 510 | 74.3% (70.4%−78.0%) | 0.95 (0.94–0.96) | 0.78 (0.75–0.82) | 0.98 |
| LIA-4 | 18 | 510 | 79.0% (75.3%−82.4%) | 0.93 (0.92–0.94) | 0.83 (0.80–0.86) | 0.92 |
| VLP-MIA | 18 | 471 | 68.2% (63.8%−72.2%) | 0.27 (0.19–0.35) | 0.73 (0.69–0.77) | 0.0072 |
| M9E | 18 | 502 | 79.3% (75.6%−82.7%) | 0.95 (0.94–0.96) | 0.83 (0.80–0.86) | 0.97 |
| GST-L1 | 18 | 509 | 46.4% (42.1%−50.7%) | 0.46 (0.38–0.52) | 0.45 (0.40–0.51) | 0.33 |
| HT-PBNA | 18 | 510 | 81.0% (77.4%−84.2%) | 0.96 (0.96–0.97) | 0.84 (0.81–0.87) | 0.70 |
Abbreviations: number (N); secreted alkaline phosphatase pseudovirion-based neutralization assay (SEAP-NA); enzyme-linked immunosorbent assay (ELISA); 4-plex Luminex immunoassay (LIA-4); VLP multiplex immune assay (VLP-MIA); M9-ELISA assay (M9E); glutathione S-transferase L1 assay (GST-L1); high-throughput pseudovirion-based neutralization assay (HT-PBNA); and confidence intervals (CI).