Human papillomavirus detection with genotyping by the cobas and Aptima assays: Significant differences in HPV 16 detection?

Chorny, Joseph A.; Frye, Teresa C.; Fisher, Beth L.; Remmers, Carol

doi:10.1002/dc.23930

Cited by 8 publications

(6 citation statements)

References 4 publications

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“…Our estimate of the prevalence of positives for the E6/E7 mRNA of 14 high‐risk HPV types in a screening population is consistent with that observed in most previous studies, ranging from 4% to 7% 21‐27 . Other studies, conducted in countries with particularly high HPV DNA prevalence, found values close to 10% 12,28‐32 . In all these studies E6/E7 mRNA positivity was consistently 15% to 30% lower than HPV DNA positivity, and specificity was consistently higher 11 …”

Section: Discussionsupporting

confidence: 90%

“…[21][22][23][24][25][26][27] Other studies, conducted in countries with particularly high HPV DNA prevalence, found values close to 10%. 12,[28][29][30][31][32] In all these studies E6/E7 mRNA positivity was consistently 15% to 30% lower than HPV DNA positivity, and specificity was consistently higher. 11 Very few studies have estimated the performance of E6/E7 mRNA-based screening with cytology triage.…”

Section: Main Findingsmentioning

confidence: 99%

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Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial

Rossi

Ronco

Mancuso

et al. 2022

Intl Journal of Cancer

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As the primary screening test, E6/E7 mRNA has shown similar sensitivity for CIN3+ and lower positivity rate than the HPV DNA test. Nevertheless, the overall mRNA positivity is too high for immediate colposcopy, making a triage test necessary. The aim was to estimate the mRNA performance as a primary test with different triage strategies. All HPV DNA-positives were tested for mRNA, cytology and p16/ki67. A sample of HPV DNA-negatives was also tested for mRNA to estimate test specificity.We included all CIN3+ histologically diagnosed within 24 months since recruitment.Of the 41 127 participants, 7.7% were HPV DNA-positive, of which 66.4% were mRNA-positive. Among the HPV DNA-negatives, 10/1108 (0.9%) were mRNA-positive. Overall, 97 CIN3+ were found. If mRNA was used as the primary test, it would miss about 3% of all CIN3+ with a 22% reduction of positivity compared with HPV DNA. The weighted specificity estimate for

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Section: Discussionsupporting

confidence: 90%

Section: Main Findingsmentioning

confidence: 99%

Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial

Rossi

Ronco

Mancuso

et al. 2022

Intl Journal of Cancer

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“…Our rates of agreement for HPV 16/18 and HPV 16/18/45 are similar to what has been previously published in one other cross‐sectional study. Chorny et al found that Cobas HPV test and Aptima HPV genotyping were comparable overall for detection of HPV genotypes in cytology samples 21 . As with the current study they reported Aptima HPV assay had a lower rate of detection of HPV 16 compared to the Cobas HPV test (1.1% vs 1.6%).…”

Section: Discussionsupporting

confidence: 79%

Performance of the HPV E6/E7 mRNA Aptima HPV assay combined with partial genotyping compared with the HPV DNA Cobas 4800 HPV test for use in primary screening: Results from the CERVIVA HPV primary screening study in Ireland

White,

Reynolds,

Murphy

et al. 2023

Intl Journal of Cancer

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There are currently several validated HPV tests. However, longitudinal data which spans appropriate age ranges, as well as evaluation of potential screening algorithms are necessary for screening programmes choice of test. The objective of our study was to evaluate the performance of HPV mRNA and HPV DNA testing, including partial genotyping, in routine cervical screening. As part of the CERVIVA HPV Primary Screening Study, ThinPrep samples from 10 150 women were tested for HPV mRNA using the Aptima HPV assay and HPV DNA using the Cobas 4800 HPV test. HPV mRNA‐positive women were further assessed with the Aptima genotyping assay for HPV 16/18/45. Baseline cytology and prospective follow‐up data were collected. The performance of the two tests was examined over 42 months (to date). HPV mRNA demonstrated equivalent sensitivity to HPV DNA testing for detection of CIN2+ (93.2% [92.4‐93.9] vs 92.8% [92.0‐93.6], respectively) and CIN3+ (94.6% [93.8‐95.3] vs 94.6% [93.8‐95.3]). HPV mRNA testing had significantly higher specificity compared to HPV DNA for detection of CIN2+ (84.0% [83.5‐84.5] vs 80.8% [80.2‐81.4], respectively) and CIN3+ (88.44% [88.2‐88.6] vs 85.62 [85.4‐85.9]). The proportion of CIN2+ and CIN3+, over 3 years (42 months), in HPV‐negative women was comparable for both RNA (0.20% and 0.10%) and DNA (0.22% and 0.11%). Genotyping data was comparable across both assay platforms. In the context of HPV primary screening HPV mRNA testing has potential to reduce triage tests and follow‐up tests at 12 months compared to DNA testing, with no significant difference in detection of CIN2+ and CIN3+.

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“…Some studies included both ThinPrep and SurePath samples and the referral criteria varied in different study settings . Some studies from the US have reported on the clinical performance of the Aptima HPV assay, the Aptima HPV16 and 18/45 genotyping assay and the Cobas 4800 HPV test in women referred to colposcopy following an ASCUS cytology smear …”

Section: Introductionmentioning

confidence: 99%

“…[16][17][18][19][20][21] Some studies from the US have reported on the clinical performance of the Aptima HPV assay, the Aptima HPV16 and 18/45 genotyping assay and the Cobas 4800 HPV test in women referred to colposcopy following an ASCUS cytology smear. [22][23][24] Recently, a number of studies have also evaluated the clinical performance of the Cobas 4800 HPV test, the Aptima HPV assay, and HC2 in population-based primary cervical screening setting. [25][26][27] In Ireland, the National Cervical Screening Program CervicalCheck offers cytology-based screening to all women aged 25-60 y.…”

Section: Introductionmentioning

confidence: 99%

Clinical performance of the Cobas 4800 HPV test and the Aptima HPV assay in the management of women referred to colposcopy with minor cytological abnormalities

Tewari

White

Kelly

et al. 2018

Diagnostic Cytopathology

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Background The aim of this study was to evaluate the clinical performance of the Cobas 4800 HPV test and the Aptima HPV assay for the detection of CIN2+ disease in women referred to colposcopy with minor cytological abnormalities. Methods ThinPrep liquid‐based cytology samples were collected from 562 women referred to colposcopy with minor cytological abnormalities. HPV testing by both assays was performed on these samples. Clinical performances for detection of histologically diagnosed CIN2+ and CIN3+ were calculated. Results HPV prevalence by the Cobas 4800 HPV test was 58.2% and 53.0% women tested positive with the Aptima HPV assay in the entire study population. The Aptima HPV assay and the Cobas 4800 HPV test displayed equivalent sensitivity of 90.2% (95%CI, 83.4‐94.9) for the detection of CIN2+ disease. However, the Aptima HPV assay displayed greater specificity of 61.0% (95% CI, 54.0‐68.0) when compared to the Cobas 4800 HPV test 53.0% (95% CI, 46.0‐60.0), and this was significantly higher (P = .0004). The Aptima HPV assay also displayed higher specificity 76.5% (95% CI, 66.0‐85.0) in the ASCUS category in comparison to the Cobas 4800 HPV test 65.0% (95% 54.0‐75.0) which was statistically significant (P = .004). Conclusions Both the tests displayed similar sensitivity. However, the Aptima HPV assay was significantly more specific in the identification of women with CIN2+ disease in a colposcopy referral population.

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Human papillomavirus detection with genotyping by the cobas and Aptima assays: Significant differences in HPV 16 detection?

Cited by 8 publications

References 4 publications

Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial

Performance of HPV E6/E7 mRNA assay as primary screening test: Results from the NTCC2 trial

Performance of the HPV E6/E7 mRNA Aptima HPV assay combined with partial genotyping compared with the HPV DNA Cobas 4800 HPV test for use in primary screening: Results from the CERVIVA HPV primary screening study in Ireland

Clinical performance of the Cobas 4800 HPV test and the Aptima HPV assay in the management of women referred to colposcopy with minor cytological abnormalities

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