Clinical performance of the aptima <scp>HPV</scp> assay in 4196 women with positive <scp>high‐risk HPV</scp> and <scp>ASC‐US</scp> cytology: A large women hospital experience

Wang, Tiannan; Pradhan, Dinesh; Zhang, Huina; Matsko, Jonee; Zhao, Chengquan

doi:10.1002/dc.24592

Cited by 5 publications

(5 citation statements)

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“…Compared with DNA-based HPV tests, the mRNA-based AHPV test shows a similar sensitivity and a higher specificity in high-grade cervical lesion detection 25. Our results showed that the prevalence of HSIL+lesions in women with ASC-US/hrHPV+ based on the Aptima assay are low (12.2%), which is similar to the findings of previous studies (<10%) 17 20 26. However, Jiang et al showed that the prevalence of HSIL+lesions in women with ASC-US/hrHPV+ based on the hrHPV genotype was 19.5% 27.…”

Section: Discussionsupporting

confidence: 87%

“…Due to these uncertainties, the management of ASC-US/hrHPV-positive patients has been challenged since the 2003 approval of cytology and HPV co-testing by the US Food Drug Administration. Particularly for Aptima assay, there were limited studies with respect to cervical pathology among ASC-US/hrHPV+women in China even decades after its implemention as an adjunct in cervical cancer screening 17. The aim of this study was to evaluate the immediate histological correlation in women with ASC-US/hrHPV+detected by Aptima assays in the Chinese population.…”

Section: Introductionmentioning

confidence: 99%

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Correlation of immediate prevalence of cervical precancers and cancers with HPV genotype and age in women with ASC-US/hrHPV+: a retrospective analysis of 2292 cases

et al. 2023

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AimsTo stratify the risk of cervical precancers (high-grade squamous intraepithelial lesion (HSIL) and adenocarcinoma in situ (AIS)) and cancers (squamous cell carcinoma (SCC) and adenocarcinoma) based on distinct high-risk human papillomavirus (hrHPV) genotypes as well as age groups among women with atypical squamous cells of undetermined significance (ASC-US) and hrHPV+results.MethodsIn total, 2292 cases of ASC-US/hrHPV+ with immediate follow-up biopsy results were included in the study for prevalence analysis.ResultsOverall, 12.2% women with ASC-US /hrHPV+ had HSIL+ while 0.22% had AIS+ lesions. The HPV-16+ group (31.6%) showed significantly higher prevalence of HSIL+ squamous lesions than other genotype groups (p<0.0001). The prevalence of SCC is significantly higher in HPV-16+ (1.8%) or HPV-18/45+ (1.1%) group than women in other genotype groups (0.1%) (p<0.0001). The HPV-18/45+ group (1.7%) showed significantly higher prevalence of AIS+ glandular lesions than other genotype groups (p=0.003). In addition, SCC prevalence was significantly higher in age over 50 group than that in age under 50 group (1.2% vs 0.2%, p=0.012).ConclusionWomen with ASC-US/hrHPV+ are at significant risk of cervical precancers and cancers; notably, HPV-16+ group has a higher risk of HSIL squamous lesions and SCC while HPV-18/45+ group has a higher risk of AIS+ glandular lesions. In addition, the older patient group (>50 years) has a significantly higher risk of SCC. Therefore, HPV genotyping as well as patient age need to be considered in the clinical management of patient.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Correlation of immediate prevalence of cervical precancers and cancers with HPV genotype and age in women with ASC-US/hrHPV+: a retrospective analysis of 2292 cases

et al. 2023

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“…A study in New York of 2145 women with ASC-US who tested positive for the Aptima HPV mRNA test and underwent colposcopic directed biopsy found that the proportion of CIN 2 + was 8.8%. When considering age groups, the highest incidence of CIN 2 + was found in those younger than 25 years compared to the age group 50–59 years, with rated of 15.4% versus 4.8%, respectively 29 . The highest detection proportion of HSIL + was in those aged ≤ 30 years (40.5%) and the lowest in the age group 51–60 years (21.7%).…”

Section: Discussionmentioning

confidence: 95%

High-risk human papillomavirus genotyping in women with atypical squamous cells of undetermined significance

Ittiamornlert,

Jareemit,

Phianpiset

et al. 2023

Sci Rep

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We conducted a prospective study to evaluate the prevalence of high-risk human papillomavirus (hr-HPV) positivity in women with atypical squamous cells of undetermined significance (ASC-US). Additionally, we assessed the association of hr-HPV positivity with the pathology of high-grade squamous intraepithelial lesions or worse (HSIL+) and the risk of subsequent detection of squamous intraepithelial lesions. A total of 376 women were included, with 242 (64.4%) exhibiting hr-HPV positivity. The predominant HPV genotypes were 16, 52 and 58. Factors associated with the immediate detection of HSIL+ pathology included a colposcopic impression of high-grade lesions, hr-HPV positivity, HPV 16 positivity, HPV 18 positivity, HPV 58 positivity, age less than 40 years, and biopsy of two or more pieces. However, only the first three factors were statistically significant in multivariate analysis. Among the 291 women who continued surveillance for 6 months or more, the median follow-up period was 41.8 months (interquartile range [IQR] 26.5–54.0). The prevalence of subsequent HSIL in women with hr-HPV positivity versus negativity was 3.6% versus 0.98%, respectively. The median time to the subsequent detection of SIL was 28.7 months (IQR 14.9–41.7). In conclusion, women with ASC-US in our study had a high proportion of hr-HPV positivity. Type-specific HPV testing could play a pivotal role in the development of specific management protocols for women with ASC-US.Clinical trial registration: https://thaiclinicaltrials.org, TCTR20161017002.

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“…They compared Aptima and Cobas platforms, and the PPV was higher for Aptima regarding ≥HSIL lesions (Aptima 20.3%, Cobas 18.8%). In 2021, Wang et al [15] performed a retrospective study with Aptima on a large group of patients with ASCUS cytology. The PPV of the Aptima platform for ≥HSIL lesions was 8.8%.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Clinical Performance of Aptima HPV Assay and the Cobas 4800 Platform in Women with Normal Cytology and Positive High-Risk HPV

2023

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Introduction: According to current the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines, patients with normal cytology results may be referred for colposcopy according to their high-risk human papillomavirus (hrHPV) test results. A higher positive predictive value (PPV) of hrHPV has significance for preventing unnecessary colposcopic examinations. Several studies have compared the performance of the Aptima assay and the Cobas 4800 platform among patients who had minor cytologic abnormality. However, in our English literature search, we found no other study that had been conducted to compare these two methods in patients with normal cytology. We thus aimed to compare the PPV of the Aptima assay and Cobas 4800 platform among women with normal cytology. Methods: Between September 2017 and October 2022, we retrospectively identified 2,919 patients who had normal cytology and hrHPV positivity who had been referred for a colposcopy. Among them, 882 agreed to undergo a colposcopy; on examination, 134 had target lesions revealed and underwent a colposcopic punch biopsy. Results: Among the patients who underwent a colposcopic punch biopsy, 49 (38.9%) were tested with Aptima, and 77 (61.1%) were tested with Cobas. In the Aptima group, 29 (59.2%) patients showed benign histology, 2 (4.1%) patients had an low-grade squamous intraepithelial lesions (LSIL), and 18 (36.7%) patients had ≥ high-grade squamous intraepithelial lesion (HSIL) biopsy results. The false positivity rate and PPV of Aptima were 63.3% (31/49) and 36.7% (95% CI:0.232-0.502), respectively, for a histopathologic diagnosis of ≥ HSIL. In the Cobas group, 48 (62.3%) biopsies were benign, 11 (14.3%) reported an LSIL, and 18 (23.4%) biopsies were ≥HSIL. The false positivity rate and PPV of Cobas were 76.6% (59/77) and 23.4% (95% CI:0.139-0.328), respectively, concerning a ≥HSIL tissue diagnosis. The false positivity rate of Aptima HPV 16 positivity was 40% (4/10). The false positivity rate of Cobas HPV 16 positivity was 61.1% (11/18). The PPVs of HPV 16 positivity for Aptima and Cobas were 60% (95% CI:0.296-0.903), and 38.9% (95% CI:0.163-0.614), respectively, concerning ≥HSIL tissue diagnosis. Discussion/Conclusion: We recommend analyzing the performances of hrHPV platforms in future larger studies in patients with normal cytology, rather than only cases with abnormal cytology.

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Clinical performance of the aptima HPV assay in 4196 women with positive high‐risk HPV and ASC‐US cytology: A large women hospital experience

Cited by 5 publications

References 20 publications

Correlation of immediate prevalence of cervical precancers and cancers with HPV genotype and age in women with ASC-US/hrHPV+: a retrospective analysis of 2292 cases

Correlation of immediate prevalence of cervical precancers and cancers with HPV genotype and age in women with ASC-US/hrHPV+: a retrospective analysis of 2292 cases

High-risk human papillomavirus genotyping in women with atypical squamous cells of undetermined significance

Comparison of the Clinical Performance of Aptima HPV Assay and the Cobas 4800 Platform in Women with Normal Cytology and Positive High-Risk HPV

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