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ASC-US and high-risk HPV testing: performance in daily clinical practice
1Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, University Hospital and Clinics, 600 Highland Avenue, Madison, WI 53792, USA. sm.selvaggi@hosp.wisc.edu
This study evaluated how high-risk HPV DNA testing performs in patients with ASC-US (atypical squamous cells of undetermined significance) results on cervical Pap tests. The researchers analyzed data from nearly 50,000 Pap tests conducted at a university hospital over three years and eleven months. Of these, 1,792 cases were diagnosed as ASC-US, and 672 of those were tested for high-risk HPV using a specific method. The results showed that 39.6% of the tested cases were positive for high-risk HPV genotypes. Among the 266 positive cases, 127 had biopsy follow-up, and 42.25% of those showed cervical abnormalities, including low-grade and high-grade lesions. The study also found that a significant number of HPV-positive cases had follow-up Pap tests indicating abnormalities. These findings suggest that HPV testing may help identify patients who need further evaluation after an ASC-US diagnosis. The results align with other recent studies on the use of HPV testing in clinical practice.
Area of Science:
- Cervical cancer screening in clinical diagnostics
- HPV testing methodologies in gynecology
- ASC-US management in routine cytology
Background:
Cervical cytology results often include atypical squamous cells of undetermined significance (ASC-US), which require further evaluation. Prior research has shown that ASC-US findings can be associated with high-risk human papillomavirus (HPV) infections, but the clinical utility of HPV testing in this context remains unclear. While some studies have explored HPV testing in ASC-US cases, the performance of this approach in daily clinical settings has not been fully established. This gap motivated the need to assess how high-risk HPV testing functions in real-world clinical practice. No prior work had resolved the extent to which HPV testing can predict cervical abnormalities in ASC-US patients. The variability in test outcomes and follow-up data has limited the ability to draw firm conclusions. This paper's contribution lies in presenting a detailed analysis of HPV testing outcomes in a specific clinical setting. The study adds clarity to the diagnostic workflow for ASC-US cases and provides data on the frequency of cervical abnormalities detected.
Purpose Of The Study:
The aim of this study was to evaluate the performance of high-risk HPV DNA testing in patients with ASC-US results in a real-world clinical setting. The researchers sought to understand how frequently HPV testing identified high-risk genotypes and whether this testing could predict cervical abnormalities. The specific problem addressed was the uncertainty surrounding the effectiveness of HPV testing as a follow-up to ASC-US findings. The motivation for this study was to provide data that could guide clinical decision-making in managing ASC-US cases. By analyzing a large cohort of patients, the study aimed to determine the diagnostic yield of HPV testing in this population. The researchers also wanted to assess the correlation between HPV positivity and subsequent biopsy or Pap test results. This information could help clinicians determine the best follow-up strategies for ASC-US patients. The study's findings could contribute to refining current guidelines for managing ASC-US cases in clinical practice.
Main Methods:
The study was conducted at the University of Wisconsin Hospital and Clinics over a period of three years and eleven months. The cytopathology laboratory processed nearly 50,000 Pap tests during this time, with 1,792 cases diagnosed as ASC-US. Of these, 672 cases were selected for high-risk HPV genotyping using the Digene Hybrid Capture II method. The researchers categorized the HPV test results into positive, equivocal, or negative categories. For cases with positive HPV results, the team reviewed biopsy follow-up data available for 127 patients. These biopsies were classified into categories such as negative, CIN I, CIN II, and CIN III. For cases without biopsy data, follow-up Pap tests were analyzed to determine the progression of abnormalities. The researchers also tracked how many patients were lost to follow-up. This approach allowed them to evaluate the diagnostic accuracy of HPV testing in identifying cervical abnormalities in ASC-US patients.
Main Results:
Of the 672 ASC-US cases tested for high-risk HPV genotypes, 266 (39.6%) were positive, 11 (1.6%) were equivocal, and 395 (58.8%) were negative. Among the 266 HPV-positive cases, biopsy follow-up was available for 127 patients. Of these, 66 (52%) were negative, 46 (36.2%) showed CIN I, 9 (7.1%) were CIN II, and 6 (4.7%) were CIN III. For the remaining 139 cases without biopsy data, 86 had follow-up Pap tests. Of these, 57 (66.3%) were negative, 15 (17.4%) were ASC-US, 12 (15%) were low-grade squamous intraepithelial lesions, and 2 (2.3%) were high-grade squamous intraepithelial lesions. A total of 53 patients were lost to follow-up. Overall, 90 of the 213 cases with follow-up data showed atypia or higher-grade abnormalities after an initial ASC-US diagnosis. Of these, 58 (64%) were low-grade lesions and 17 (19%) were high-grade lesions. These results suggest that HPV testing identified a significant number of cervical abnormalities in ASC-US patients.
Conclusions:
The study found that high-risk HPV testing in ASC-US patients identified a notable proportion of cervical abnormalities, with 39.6% of tested cases being positive for high-risk genotypes. The researchers observed that a significant number of HPV-positive cases had biopsy or follow-up Pap test results indicating low-grade or high-grade lesions. These findings suggest that HPV testing can serve as a useful tool in the management of ASC-US cases in clinical practice. The study also showed that a substantial number of HPV-positive patients had follow-up data indicating cervical abnormalities. The results indicate that HPV testing may help clinicians identify patients who require further evaluation or intervention. The authors propose that these findings support the use of HPV testing as part of the diagnostic workflow for ASC-US cases. The study's data align with recent reports on the use of HPV testing in ASC-US management. The authors conclude that HPV testing can provide valuable diagnostic information in the context of ASC-US findings.
Frequently Asked Questions
High-risk HPV testing in ASC-US cases helps identify patients with potential cervical abnormalities. The study found that 39.6% of tested cases were positive for high-risk genotypes.
The researchers categorized HPV test results into positive, equivocal, or negative groups. Of 672 cases, 266 were positive, 11 were equivocal, and 395 were negative.
The Digene Hybrid Capture II method was used to detect high-risk HPV genotypes in ASC-US cases. It is a widely used and validated technique for HPV testing.
Among 127 HPV-positive cases with biopsy follow-up, 66 were negative, 46 showed CIN I, 9 were CIN II, and 6 were CIN III.
A total of 53 patients were lost to follow-up, which affected the ability to fully assess the diagnostic accuracy of HPV testing in this group.
The study suggests that HPV testing may help identify patients with cervical abnormalities after an ASC-US diagnosis. It supports the use of HPV testing in clinical decision-making.
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