Evidence map›Paper›PMID 26088703›Full record

ArticleCancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology2015

The Role of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Large-Scale Evaluation of the cobas HPV Test.

Mark Schiffman, Sean Boyle, Tina Raine-Bennett, Hormuzd A Katki, Julia C Gage, Nicolas Wentzensen, Janet R Kornegay, Raymond Apple, Carrie Aldrich, Henry A Erlich and 4 more

Abstract readComparative Study
In one paragraph

Article in Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Carcinogenicity of Human Papillomavirus (HPV) Types in HIV-Positive Women: A Meta-Analysis From HPV Infection to Cervical Cancer.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
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  16. Role of HPV Genotype, Multiple Infections, and Viral Load on the Risk of High-Grade Cervical Neoplasia.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2019
    Article
  17. Article
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  20. Precancerous cervical lesions and HPV genotypes identified in previously unsatisfactory cervical smear tests after inexpensive glacial acetic acid processing.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Mark SchiffmanNational Cancer Institute, Bethesda, Maryland. schiffmm@mail.nih.gov.
Sean BoyleRoche Molecular Systems, Pleasanton, California.
Tina Raine-BennettKaiser Permanente Northern California, Oakland, California.
Hormuzd A KatkiNational Cancer Institute, Bethesda, Maryland.
Julia C GageNational Cancer Institute, Bethesda, Maryland.
Nicolas WentzensenNational Cancer Institute, Bethesda, Maryland.
Janet R KornegayRoche Molecular Systems, Pleasanton, California.
Raymond AppleRoche Molecular Systems, Pleasanton, California.
Carrie AldrichRoche Molecular Systems, Pleasanton, California.
Henry A ErlichRoche Molecular Systems, Pleasanton, California.
Thanh TamRoche Molecular Systems, Pleasanton, California.
Brian BefanoInformation Management Services, Calverton, Maryland.
Robert D BurkAlbert Einstein College of Medicine, The Bronx, New York.
Philip E CastleDepartment of Epidemiology and Population Health, Albert Einstein College of Medicine, The Bronx, New York. Global Coalition Against Cervical Cancer, Arlington, Virginia.

Funding

Human papillomavirus (HPV) infection and cervical and anal cancersZIACP010124 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI WENTZENSEN, NICOLAS · 2009 to 2025
$17.3M
Human Papillomavirus (HPV) Natural History, Genomics and Risk AssessmentZIACP010206 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI SCHIFFMAN, MARK · 2010 to 2025
$17.1M
PERSISTENT HUMAN PAPILLOMAVIRUS IN WOMEN AT RISK FOR CERVIX CANCERU01CA078527 · NCI · YESHIVA UNIVERSITY · PI BURK, ROBERT D · 2003 to 2018
$8.6M
CERVICAL CANCER AND HUMAN PAPILLOMAVIRUS (HPV) INFECTIONZ01CP010124 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI SCHIFFMAN, MARK · 1996 to 2008
$3.0M
Intramural NIH HHS Z01 CP010124NCI NIH HHS U01 CA078527
6 · The paper itself

Abstract

backgroundThe cobas HPV Test ("cobas"; Roche Molecular Systems) detects HPV16 and HPV18 individually, and a pool of 12 other high-risk (HR) HPV types. The test is approved for (i) atypical squamous cells of undetermined significance (ASC-US) triage to determine need for colposcopy, (ii) combined screening with cytology ("cotesting"), and (iii) primary HPV screening.

methodsTo assess the possible value of HPV16/18 typing, >17,000 specimens from a longitudinal cohort study of initially HPV-positive women (HC2, Qiagen) were retested with cobas. To study accuracy, cobas genotyping results were compared with those of an established method, the Linear Array HPV Genotyping Test (LA, Roche Molecular Systems). Clinical value of the typing strategy was evaluated by linking the cobas results (supplemented by other available typing results) to 3-year cumulative risks of CIN3+.

resultsGrouped hierarchically (HPV16, else HPV18, else other HR types, else negative), the κ statistic for agreement between cobas and LA was 0.86 [95% confidence interval (CI), 0.86-0.87]. In all three scenarios, HPV16-positive women were at much higher 3-year risk of CIN3+ than HPV16-negative women: women ages 21 and older with ASC-US (14.5%; 95% CI, 13.5%-15.5% vs. 3.5%; 95% CI, 3.3-3.6); women ages 30 years and older that were HPV-positive cytology-negative (10.3%; 95% CI, 9.6-11.1 vs. 2.3%; 95% CI, 2.2-2.4); and all women 25 years and older that were HPV-positive (18.5%; 95% CI, 17.8-19.2 vs. 4.3%; 95% CI, 4.2-4.4).

conclusionThe cobas and LA results show excellent agreement. The data support HPV16 typing. IMPACT: HPV16 typing is useful in the management of HPV-positive/cytology-negative women in cotesting, of all HPV-positive women in primary HPV testing, and perhaps in the management of HPV-positive women with ASC-US. Cancer Epidemiol Biomarkers Prev; 24(9); 1304-10.

Indexed as

Genotyping TechniquesAdultAgedAged, 80 and overAtypical Squamous Cells of the CervixCohort StudiesEarly Detection of CancerFemaleHuman papillomavirus 16Human papillomavirus 18HumansMiddle AgedRisk FactorsUterine Cervical DysplasiaUterine Cervical NeoplasmsYoung Adult

Identifiers

PMID26088703
PMCPMC4560647

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.