Table 1.
Clinical performance of carcinogenic HPV detection by Amplicor and Hybrid Capture 2 (hc2) for 2-year cumulative cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) as diagnosed by quality control pathology and 2-year cumulative CIN2+diagnosed by clinical center pathology (n=3,286) as well as restricted to the IC arm (n=1,081) in women referred into ALTS for an atypical squamous cell of undetermined significance (ASCUS) Pap.
| All study arms, Outcome=QC-CIN3+ (n=235) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test | Sens (%) |
(CI) | p | Spec (%) |
(CI) | p | PPV (%) |
(CI) | p | NPV (%) | (CI) | p | Youden | Referral (%) |
p | Invalid | N |
| Amplicor 0.2 | 95.8 | (92.8–97.8) | 0.01 | 38.9 | (37.1–40.6) | <0.001 | 13.0 | (11.6–14.5) | <0.001 | 98.98 | (98.22–99.47) | 0.13 | 34.7 | 64.1 | <0.001 | 9 | 3277 |
| Amplicor 1.0 | 93.3 | (89.8–95.9) | 0.80 | 44.6 | (42.8–46.4) | <0.001 | 13.8 | (12.3–15.4) | <0.001 | 98.59 | (97.81–99.15) | 0.89 | 37.9 | 58.7 | <0.001 | 9 | 3277 |
| Amplicor 1.5 | 92.6 | (89.0–95.4) | 1.00 | 47.5 | (45.7–49.3) | <0.001 | 14.4 | (12.8–16.1) | 0.007 | 98.54 | (97.78–99.10) | 0.74 | 40.2 | 56.0 | <0.001 | 9 | 3277 |
| hc2 | 92.6 | (89.0–95.4) | Ref | 50.6 | (48.8–52.4) | Ref | 15.1 | (13.5–16.9) | Ref | 98.64 | (97.92–99.15) | Ref | 43.2 | 53.2 | Ref | . | 3286 |
| All study arms, Outcome=CC–CIN2+ (n=399) | |||||||||||||||||
| Test |
Sens (%) |
(CI) | p |
Spec (%) |
(CI) | p |
PPV (%) |
(CI) | p | NPV (%) | (CI) | p | Youden |
Referral (%) |
p | Invalid | N |
| Amplicor 0.2 | 93.0 | (90.4–95.1) | 0.12 | 41.1 | (39.2–42.9) | <0.001 | 22.1 | (20.4–24.0) | <0.001 | 97.02 | (95.88–97.92) | 0.77 | 34.05 | 64.1 | <0.001 | 9 | 3277 |
| Amplicor 1.0 | 90.6 | (87.7–93.0) | 0.74 | 47.0 | (45.1–48.9) | <0.001 | 23.5 | (21.7–25.5) | <0.001 | 96.52 | (95.40–97.43) | 0.15 | 37.59 | 58.7 | <0.001 | 9 | 3277 |
| Amplicor 1.5 | 89.4 | (86.4–92.0) | 0.20 | 50.1 | (48.2–51.9) | <0.001 | 24.4 | (22.4–26.4) | <0.001 | 96.33 | (95.22–97.24) | 0.05 | 39.45 | 56.0 | <0.001 | 9 | 3277 |
| hc2 | 91.0 | (88.2–93.4) | Ref | 53.7 | (51.8–55.5) | Ref | 26.2 | (24.1–28.3) | Ref | 97.08 | (96.11–97.86) | Ref | 44.7 | 53.2 | Ref | . | 3286 |
| Immediate colposcopy arm, Outcome=QC–CIN3+ (n=57) | |||||||||||||||||
| Test |
Sens (%) |
(CI) | p |
Spec (%) |
(CI) | p |
PPV (%) |
(CI) | p | NPV (%) | (CI) | p | Youden |
Referral (%) |
p | Invalid | N |
| Amplicor 0.2 | 92.7 | (82.4–98.0) | 0.06 | 36.2 | (33.3–39.3) | <0.001 | 7.2 | (5.4–9.4) | 0.0006 | 98.93 | (97.29–99.71) | 0.24 | 29.0 | 65.2 | <0.001 | 2 | 1079 |
| Amplicor 1.0 | 92.7 | (82.4–98.0) | 0.38 | 41.6 | (38.6–44.7) | <0.001 | 7.9 | (5.9–10.2) | 0.049* | 99.07 | (97.64–99.75) | 0.48 | 34.3 | 60.1 | <0.001 | 2 | 1079 |
| Amplicor 1.5 | 90.9 | (80.1–97.0) | 0.63 | 44.6 | (41.6–47.7) | 0.038* | 8.1 | (6.1–10.5) | 0.35 | 98.92 | (97.49–99.65) | 0.53 | 35.5 | 57.2 | 0.03* | 2 | 1079 |
| hc2 | 90.9 | (80.1–97.0) | Ref | 48.0 | (44.9–51.1) | Ref | 8.6 | (6.4–11.1) | Ref | 98.99 | (97.67–99.67) | Ref | 38.9 | 54.0 | Ref | . | 1081 |
| Immediate colposcopy arm, Outcome=CC–CIN2+ (n=115) | |||||||||||||||||
| Test |
Sens (%) |
(CI) | p |
Spec (%) |
(CI) | p |
PPV (%) |
(CI) | p | NPV (%) | (CI) | p | Youden |
Referral (%) |
p | Invalid | N |
| Amplicor 0.2 | 91.7 | (84.9–96.2) | 0.23 | 37.7 | (34.7–40.9) | <0.001 | 14.2 | (11.7–17.0) | <0.001 | 97.60 | (95.49–98.90) | 0.91 | 29.5 | 65.2 | <0.001 | 2 | 1079 |
| Amplicor 1.0 | 89.0 | (81.6–94.2) | 1.00 | 43.1 | (40.0–46.3) | <0.001 | 15.0 | (12.3–17.9) | 0.0010 | 97.21 | (95.18–98.55) | 0.57 | 32.1 | 60.1 | <0.001 | 2 | 1079 |
| Amplicor 1.5 | 88.1 | (80.5–93.5) | 1.00 | 46.3 | (43.1–49.5) | 0.019* | 15.6 | (12.8–18.7) | 0.042* | 97.19 | (95.24–98.49) | 0.50 | 34.4 | 57.2 | 0.03* | 2 | 1079 |
| hc2 | 89.9 | (82.7–94.9) | Ref | 50.0 | (46.8–53.2) | Ref | 16.8 | (13.8–20.1) | Ref | 97.79 | (96.07–98.89) | Ref | 39.9 | 54.0 | Ref | . | 1081 |
Sens= Sensitivity; Spec= Specificity; PPV= Positive predictive value; NPV= Negative predictive value; CI= 95% confidence interval. Invalid indicates samples with a globin results below 0.2 and an HPV result below the respective cutoff. Differences in sensitivity, specificity, and referral were tested for statistical significance using an exact McNemar’s χ2 test. Differences in PPV and NPV were determined by a method developed by Leisenring and Pepe (30).
An indicates that the result was not significant after correction for multiple testing.