Table 2.
Assay Reproducibility for HPV-16/18 by Dose Groups.
| Assay | HPV Type | N Samples (N Results) | Seropositive (%) | GMT* | %CV | %CV 95% CI | ICC | ICC 95% CI |
|---|---|---|---|---|---|---|---|---|
| HPV-16 ASSAYS | ||||||||
| SAMPLES FROM SINGLE DOSE RECIPIENTS | ||||||||
| ELISA | 16 | 105 (210) | 97.1 | 19.2 | 7.1 | (6.1–8.3) | 0.95 | (0.93–0.97) |
| LIA-4 | 16 | 137 (274) | 99.3 | 15.7 | 5.4 | (4.7–6.2) | 0.98 | (0.97–0.99) |
| VLP-MIA | 16 | 83 (166) | 99.4 | 7.4 | 18.0 | (15.2–21.3) | 0.77 | (0.68–0.85) |
| M9E | 16 | 118 (236) | 98.3 | 12.1 | 4.7 | (4.0–5.5) | 0.99 | (0.99–0.99) |
| GST-L1 | 16 | 102 (204) | 99.5 | 760.2 | 4.0 | (3.5–4.6) | 0.90 | (0.86–0.93) |
| HT-PBNA | 16 | 104 (208) | 98.6 | 25.9 | 11.1 | (9.6–13.0) | 0.87 | (0.82–0.91) |
| SAMPLES FROM REDUCED DOSE RECIPIENTS | ||||||||
| ELISA | 16 | 107 (214) | 100.0 | 92.0 | 4.0 | (3.5–4.6) | 0.96 | (0.95–0.98) |
| LIA-4 | 16 | 148 (296) | 100.0 | 72.4 | 3.6 | (3.2–4.0) | 0.98 | (0.97–0.98) |
| VLP-MIA | 16 | 27 (54) | 100.0 | 15.8 | 20.6 | (15.5–27.2) | 0.44 | (0.18–0.73) |
| M9E | 16 | 112 (224) | 100.0 | 81.9 | 2.4 | (2.1–2.8) | 0.99 | (0.98–0.99) |
| GST-L1 | 16 | 97 (194) | 100.0 | 2135.6 | 3.8 | (3.3–4.4) | 0.82 | (0.74–0.87) |
| HT-PBNA | 16 | 101 (202) | 100.0 | 161.2 | 4.8 | (4.1–5.5) | 0.95 | (0.93–0.97) |
| SAMPLES FROM FULL DOSE RECIPIENTS | ||||||||
| ELISA | 16 | 108 (216) | 99.1 | 222.4 | 3.6 | (3.1–4.1) | 0.97 | (0.96–0.98) |
| LIA-4 | 16 | 144 (288) | 99.0 | 184.1 | 7.5 | (6.7–8.5) | 0.84 | (0.79–0.88) |
| VLP-MIA | 16 | 9 (18) | 100.0 | 29.1 | 20.8 | (12.8–33.7) | 0.37 | (0.05–0.87) |
| M9E | 16 | 120 (240) | 100.0 | 209.3 | 2.4 | (2.1–2.7) | 0.99 | (0.98–0.99) |
| GST-L1 | 16 | 98 (196) | 100.0 | 3134.0 | 3.0 | (2.6–3.5) | 0.77 | (0.67–0.84) |
| HT-PBNA | 16 | 99 (198) | 100.0 | 498.7 | 3.7 | (3.2–4.3) | 0.96 | (0.94–0.97) |
| ALL SAMPLES REGARDLESS OF NUMBER OF DOSES | ||||||||
| ELISA | 16 | 320 (640) | 98.8 | 74.8 | 4.5 | (4.2–4.9) | 0.98 | (0.98–0.98) |
| LIA-4 | 16 | 429 (858) | 99.4 | 60.8 | 6.3 | (5.8–6.8) | 0.96 | (0.95–0.97) |
| VLP-MIA | 16 | 119 (238) | 99.6 | 9.8 | 19.5 | (17.0–22.5) | 0.74 | (0.65–0.82) |
| M9E | 16 | 350 (700) | 99.4 | 59.9 | 2.9 | (2.7–3.1) | 0.99 | (0.99–1.00) |
| GST-L1 | 16 | 297 (594) | 99.8 | 1702.2 | 3.6 | (3.3–3.9) | 0.92 | (0.90–0.93) |
| HT-PBNA | 16 | 304 (608) | 99.5 | 125.5 | 5.9 | (5.4–6.5) | 0.96 | (0.96–0.97) |
| HPV-18 ASSAYS | ||||||||
| SAMPLES FROM SINGLE DOSE RECIPIENTS | ||||||||
| ELISA | 18 | 105 (210) | 94.3 | 10.3 | 11.3 | (9.7–13.2) | 0.91 | (0.87–0.93) |
| LIA-4 | 18 | 137 (274) | 63.9 | 6.7 | 18.2 | (14.8–22.3) | 0.96 | (0.95–0.97) |
| VLP-MIA | 18 | 96 (192) | 92.7 | 5.9 | 16.5 | (14.0–19.6) | 0.88 | (0.83–0.92) |
| M9E | 18 | 118 (236) | 87.3 | 6.0 | 8.1 | (6.7–9.7) | 0.99 | (0.98–0.99) |
| GST-L1 | 18 | 102 (204) | 73.0 | 308.2 | 11.6 | (10.0–13.3) | 0.75 | (0.66–0.83) |
| HT-PBNA | 18 | 104 (208) | 94.7 | 8.6 | 10.8 | (9.1–12.8) | 0.95 | (0.92–0.96) |
| SAMPLES FROM REDUCED DOSE RECIPIENTS | ||||||||
| ELISA | 18 | 107 (214) | 99.5 | 35.6 | 6.0 | (5.2–6.9) | 0.95 | (0.93–0.97) |
| LIA-4 | 18 | 148 (296) | 95.3 | 15.8 | 6.3 | (5.5–7.2) | 0.98 | (0.98–0.99) |
| VLP-MIA | 18 | 78 (156) | 100.0 | 19.7 | 17.2 | (14.5–20.5) | 0.74 | (0.63–0.83) |
| M9E | 18 | 112 (224) | 98.2 | 33.1 | 4.3 | (3.7–5.0) | 0.99 | (0.98–0.99) |
| GST-L1 | 18 | 97 (194) | 96.4 | 446.7 | 5.9 | (5.1–6.8) | 0.82 | (0.75–0.88) |
| HT-PBNA | 18 | 101 (202) | 100.0 | 43.2 | 5.1 | (4.4–6.0) | 0.98 | (0.96–0.98) |
| SAMPLES FROM FULL DOSE RECIPIENTS | ||||||||
| ELISA | 18 | 108 (216) | 99.1 | 85.6 | 5.2 | (4.5–6.0) | 0.96 | (0.94–0.97) |
| LIA-4 | 18 | 144 (288) | 98.3 | 37.1 | 7.6 | (6.7–8.6) | 0.95 | (0.93–0.96) |
| VLP-MIA | 18 | 52 (104) | 99.0 | 29.9 | 19.6 | (15.9–24.0) | 0.62 | (0.45–0.77) |
| M9E | 18 | 120 (240) | 99.2 | 74.8 | 3.6 | (3.1–4.1) | 0.99 | (0.98–0.99) |
| GST-L1 | 18 | 98 (196) | 96.4 | 721.8 | 6.3 | (5.4–7.2) | 0.82 | (0.75–0.88) |
| HT-PBNA | 18 | 100 (200) | 99.0 | 115.9 | 3.8 | (3.3–4.5) | 0.98 | (0.98–0.99) |
| ALL SAMPLES REGARDLESS OF NUMBER OF DOSES | ||||||||
| ELISA | 18 | 320 (640) | 97.7 | 32.5 | 6.8 | (6.3–7.5) | 0.97 | (0.96–0.97) |
| LIA-4 | 18 | 429 (858) | 86.2 | 17.9 | 9.0 | (8.2–9.8) | 0.98 | (0.97–0.98) |
| VLP-MIA | 18 | 226 (452) | 96.7 | 13.3 | 18.6 | (16.7–20.7) | 0.85 | (0.80–0.88) |
| M9E | 18 | 350 (700) | 94.9 | 26.1 | 4.6 | (4.2–5.1) | 0.99 | (0.99–0.99) |
| GST-L1 | 18 | 297 (594) | 88.4 | 477.9 | 8.0 | (7.3–8.7) | 0.83 | (0.79–0.86) |
| HT-PBNA | 18 | 305 (610) | 97.9 | 35.2 | 5.8 | (5.2–6.3) | 0.98 | (0.98–0.99) |
*
GMT is calculated among positive samples. Titers are presented in IU/mL for ELISA, LIA-4, VLP-MIA, M9E, and HT-PBNA. For GST-L1 Titers are presented as Median Fluorescence Intensity.
Abbreviations: number (N); 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); coefficient of variation (CV); intraclass correlation coefficient (ICC); and confidence intervals (CI).