Optimizing the hybrid capture II human papillomavirus test to detect cervical intraepithelial neoplasia

To estimate the optimal relative light unit ratio, and correspondingly viral load, of the hybrid capture II oncogenic human papillomavirus deoxyribonucleic acid test for detecting cervical intraepithelial neoplasia (CIN).

Women with abnormal cytology were referred for colposcopy, and a cervical swab or brush specimen was obtained for human papillomavirus testing. Sensitivities, specificities, and likelihood ratios of different relative light unit ratio cutoffs were calculated using a reference standard of colposcopy or biopsy of either CIN II+ (CIN II, III, or carcinoma), or CIN I+ (CIN I, CIN II+). The receiver operating characteristic curve was used to estimate optimal test-positive cutoff points for the hybrid capture II test.

CIN II+ was found in 18.7% (98 of 524) and CIN I in 10.5% (55 of 524) of the women. The optimal relative light unit ratio was 15.56, giving a sensitivity and specificity of 82.7% and 73.2% for CIN II+, and 74.2% and 77.8% for CIN I+. In a stratified analysis, a higher relative light unit cutoff (15.19) optimized sensitivity and specificity for CIN II+ (sensitivity 81.8%, specificity 51.5%) for women with low-grade squamous intraepithelial lesions cytology, whereas the optimal cutoff was 2.36 (sensitivity 100%, specificity 73.0%) for women with atypical squamous cells of undetermined significance, yielding referral rates of 53.3% and 28.7%, respectively. Use of a swab or brush was not associated with the level of human papillomavirus detected (P >.05).

Use of a higher cutoff for the relative light unit ratio (higher viral load) of the hybrid capture II test may improve the management of women, especially those with low-grade squamous intraepithelial lesions cytology.