TABLE 3.
Clinical performance of three assays in the detection of HR HPV DNA in cervical specimens collected from women with ASC-US to identify women with CIN 2/3
| Group and testa | Results [% (95% CI)] for: |
||||
|---|---|---|---|---|---|
| Sensitivity | Specificity | PPV | NPV | Colposcopy referral rate | |
| All women (n = 392)b | |||||
| HC-2 | 93.1 (77.0-99.2) | 72.2 (67.4-76.5) | 21.1 (14.9-29.0) | 99.2 (97.1-100.0) | 32.7 (28.2-39.0) |
| Amplicor 0.2 | 89.7 (72.8-97.2) | 62.5 (57.5-52.4) | 16.1 (11.1-22.5) | 98.7 (96.1-99.7) | 41.3 (36.6-46.3) |
| Amplicor 1.0 | 89.7 (72.8-97.2) | 64.5 (59.4-69.2) | 16.8 (11.7-23.5) | 98.7 (96.2-99.7) | 39.5 (34.8-44.5) |
| Amplicor 1.5 | 89.7 (72.8-97.2) | 64.7 (59.7-69.5) | 16.9 (11.7-23.6) | 98.7 (96.2-99.7) | 39.3 (34.6-44.2) |
| LA 13 HR | 89.7 (72.8-97.2) | 64.2 (59.1-69.0) | 16.7 (11.6-23.4) | 98.7 (96.2-99.7) | 39.9 (35.2-45.8) |
| LA 20 HR | 93.1 (77.0-99.2) | 60.1 (54.9-65.0) | 15.7 (11.0-21.9) | 99.1 (96.5-99.9) | 43.9 (39.1-48.8) |
| Women over 30 years of age (n = 301)c | |||||
| HC-2 | 91.3 (72.0-98.8) | 75.2 (69.8-79.9) | 23.3 (15.7-33.1) | 99.1 (96.4-100.0) | 29.9 (25.1-35.3) |
| Amplicor 0.2 | 87.0 (67.0-96.3) | 68.4 (62.7-73.5) | 18.5 (12.2-27.0) | 98.5 (95.3-99.7) | 35.9 (30.7-40.7) |
| Amplicor 1.0 | 87.0 (67.0-96.3) | 70.1 (64.5-75.2) | 19.4 (12.9-28.2) | 98.5 (95.4-99.7) | 34.2 (29.1-39.7) |
| Amplicor 1.5 | 87.0 (67.0-96.3) | 70.5 (64.9-75.6) | 19.6 (13.0-28.4) | 98.5 (95.5-99.7) | 33.9 (28.8-39.4) |
| LA 13 HR | 87.0 (67.0-96.3) | 69.1 (63.4-74.2) | 18.9 (12.5-27.4) | 98.5 (95.4-99.7) | 35.2 (30.0-40.7) |
| LA 20 HR | 91.3 (72.0-98.8) | 63.3 (57.5-68.8) | 17.1 (11.4-24.8) | 98.3 (95.0-99.7) | 40.5 (35.1-46.1) |
a
Four women (three over 30 years of age) had a diagnosis of CIN that could not be graded and were not included in the table. One was positive by HC-2, and two were positive with Amplicor with a cutoff at 0.2. See footnote a of Table 1 for abbreviations not listed here. Amplicor 0.2, 1.0, and 1.5, cutoffs used in Amplicor; LA 13 HR, linear array test considering the 13 genotypes targeted by the generic assays; LA 20 HR, linear array considering the 20 definitive/probable/possible HR types (3).
b
Includes 29 women with CIN 2/3.
c
Includes 23 women with CIN 2/3.