Objective: To evaluate the efficiency of human papillomavirus (HPV) testing
by Hybrid Capture II (Digene Diagnostics Inc., Silver Spring, MD) with reg
ard to detecting biopsy-confirmed cervical intraepithelial neoplasia (CIN)
or high-grade CIN in women with mild atypia, compared with the efficiencies
of polymerase chain reaction (FCR), Southern blot hybridization, and cytol
ogy.
Methods: We prospectively studied 378 women with atypical squamous cells of
undetermined significance (ASCUS) (n = 111) or low-grade squamous intraepi
thelial lesions (SILs) (n = 267) demonstrated by referral cytology. We did
repeat cytology, sampling for detection of HPV DNA by Hybrid Capture II, PC
R, and Southern blot hybridization, and colposcopic evaluation with cervica
l biopsies.
Results: All participants underwent the Hybrid Capture II test and 320 unde
rwent the three HPV tests. Sensitivities of Hybrid Capture II for detecting
CIN and high-grade CIN (0.81 and 0.86, respectively) were similar to those
of cytology (0.83 and 0.82, respectively) and PCR (0.77 and 0.95, respecti
vely), and higher than those of Southern blot hybridization (0.48 and 0.45,
respectively). Compared with cytology, combined triage with Hybrid Capture
II improved sensitivities for detecting CIN (0.94 versus 0.83, P < .001) a
nd high-grade CIN (0.96 versus 0.85), though the latter difference was not
significant (P = .17). In women with ASCUS, sensitivities of combined triag
e and cytology for detecting CIN were 0.94 and 0.71, respectively (P = .01)
, and sensitivities of the two methods for detecting high-grade CIN were 0.
92 and 0.66, respectively (P = .13). The increase in sensitivity was lower
among women with low-grade SILs; for these women, cytology had high sensiti
vity (0.86 for CIN and 1.00 for high-grade GIN). The specificity of combine
d triage was significantly lower than that of: cytology in both groups.
Conclusion: Compared with repeat cytology, combined triage with HPV testing
markedly improves sensitivity for detecting CIN in women with ASCUS, but a
t the expense of specificity. (Obstet Gynecol 2000;95:821-7. (C) 2000 by Th
e American College of Obstetricians and Gynecologists).