Donna Armylagos

Clinical performance of the Food and Drug Administration-Approved high-risk HPV test for the detection of high-grade cervicovaginal lesions.

In recent years, high‐risk human papillomavirus (hrHPV) testing for triaging atypical squamous cells of undetermined significance and cotesting with cytology have been implemented in clinical practice. However, clinical data for primary screening with human papillomavirus (HPV) testing alone are currently lacking.

Performance of Aptima and Cobas HPV testing platforms in detecting high-grade cervical dysplasia and cancer

Human papillomavirus (HPV) tests and genotyping have been used in clinical risk assessment. The purpose of this study was to analyze the performance of 2 common HPV testing platforms in detecting high‐grade cervical lesions (high‐grade squamous intraepithelial lesion [HSIL] or worse [≥HSIL]).

Aptima Human Papillomavirus E6/E7 mRNA Test Results Strongly Associated with Risk for High-Grade Cervical Lesions in Follow-Up Biopsies

Objective Human papillomavirus (HPV) tests and genotyping (GT) have been used in clinical risk assessment. The purpose of this study was to analyze the performance of 2 common HPV testing platforms in risk evaluation for high-grade cervical lesions. Materials and Methods Between January 1, 2015, and December 31, 2016, a total of 4,562 Pap tests with follow-up biopsies in our laboratory database were analyzed along with HPV tests performed on Cobas (CHPV, n = 3,959) or Aptima (AHPV, n = 603) platforms. Results The sensitivity for biopsy-confirmed HSIL or worse lesions was 97% for both CHPV and AHPV (p = .75). AHPV showed significantly lower positive rates than CHPV in benign (56% vs 86%) or LSIL (66% vs 90%) biopsies, resulting in significantly higher specificity for HSIL or worse than CHPV (38% vs 12%, p < .001). AHPV demonstrated significantly higher positive predictive value for HSIL or worse (24% vs 16%, p < .001) and overall accuracy (48% vs 24%, p < .001) than CHPV. AHPV GT also had significantly higher specificity for biopsy-confirmed HSIL or worse than CHPV (88% vs 72%, p < .001) with comparable sensitivity (50% vs 51%, p = .75). Women with HPV 16 on AHPV were significantly more likely to have HSIL or worse on biopsies than those with HPV 16 on CHPV (likelihood ratio = 4.3 vs 2.0, p = .004). Conclusions Although both AHPV and CHPV were highly sensitive for biopsy-confirmed HSIL or worse lesions, AHPV and GT demonstrated significantly higher specificity and positive predictive value than CHPV. The difference is probably related to E6/E7 overexpression after viral DNA integration in high-grade lesions. The significantly higher specificity and overall accuracy of AHPV and GT for HSIL or worse lesions may be useful in clinical risk management.

Negative Pap tests in women with high-grade cervical lesions on follow-up biopsies: Contributing factors and role of human papillomavirus genotyping

Previous studies have indicated that negative Papanicolaou (Pap) tests can precede high‐grade cervical lesions (HGCL) on biopsy. This study aims to determine the contributing factors for cytologic discrepancy and the potential role of human papilloma virus (HPV) testing in risk evaluation of women with negative Pap tests.

Do Infection Patterns of Human Papillomavirus Affect the Cytologic Detection of High-Grade Cervical Lesions on Papanicolaou Tests?

CONTEXT - Persistent infection with high-risk human papillomavirus (hrHPV) is the major cause of cervical cancer. The effect of HPV infection patterns on cytologic detection of cervical lesions is unknown. OBJECTIVE - To determine the effect of HPV infection patterns on the sensitivity of cytologic detection of high-grade cervical lesions. DESIGN - Papanicolaou tests from 257 women with biopsy-confirmed, high-grade squamous intraepithelial lesions were analyzed with respect to HPV infection patterns. RESULTS - Among 257 biopsy-confirmed, high-grade squamous intraepithelial lesion cases, the preceding cytology showed 20 cases (8%) were benign; 166 cases (65%) were low-grade cervical lesions, including atypical squamous cell of undetermined significance and low-grade squamous intraepithelial lesions; and 71 cases (28%) were high-grade cervical lesions, including atypical squamous cells cannot rule out high-grade squamous intraepithelial lesion (atypical squamous cell-high), atypical glandular cells, and high-grade squamous intraepithelial lesions. In 236 cases tested for HPV, those exhibiting low-grade cervical lesions on cytology were often associated with coinfections of mixed hrHPV genotypes (31 of 40; 78%) or non-16/18 hrHPV (75/103; 73%), compared with single-genotype infections of HPV-16 (33 of 62; 53%) or HPV-18 (2 of 6; 33%) ( P = .001). In contrast, high-grade cervical lesion cytomorphology tended to associate with the single-genotype infection of HPV-16 (20 of 62; 32%) or HPV-18 (3 of 6; 50%), compared with non-16/18 hrHPV (25 of 103; 24%) or multigenotype infection (8 of 40; 20%) ( P = .01). CONCLUSIONS - Our findings suggest that multigenotypic or non-16/18 hrHPV infections often produce deceptive lower-grade cytomorphology, which could result in underdiagnosis and delay of treatment. The HPV infection patterns may offer unrecognized benefit beyond HPV genotyping and should be considered during clinical risk evaluation of women with lower-grade cytology.