Evidence map›Paper›PMID 39158405›Full record

ArticleCancer cytopathology2024

RNA extended interventional nucleic acid longitudinal study: Clinical performance of Aptima messenger RNA HPV testing in cervical cancer screening with a 9-year follow-up.

Rosario Granados, Joanny A Duarte, David R Luján, Ana M Gutierrez-Pecharromán, Isabel Solís, Lourdes Molpeceres, Paloma Bajo, Elsa Palencia, Nuria Martín

Abstract read
In one paragraph

Article in Cancer cytopathology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Rosario GranadosDepartment of Pathology, Hospital Universitario de Getafe, Madrid, Spain.ORCID 0000-0002-9482-622X
Joanny A DuarteDepartment of Pathology, Hospital Universitario de Getafe, Madrid, Spain.
David R LujánDepartment of Pathology, Hospital Universitario de Getafe, Madrid, Spain.
Ana M Gutierrez-PecharrománDepartment of Pathology, Hospital Universitario de Getafe, Madrid, Spain.
Isabel SolísDepartment of Gynecology, Hospital Universitario de Getafe, Madrid, Spain.
Lourdes MolpeceresDepartment of Gynecology, Hospital Universitario de Getafe, Madrid, Spain.
Paloma BajoDepartment of Pathology, Hospital Universitario de Getafe, Madrid, Spain.
Elsa PalenciaDepartment of Gynecology, Hospital Universitario de Getafe, Madrid, Spain.
Nuria MartínDepartment of Gynecology, Hospital Universitario de Getafe, Madrid, Spain.

Funding

Hologic Deutschland GmbH in.The Foundation for Biomedical Research Hospital Universitario de Getafe
6 · The paper itself

Abstract

backgroundThere is a need for additional longitudinal studies with the Aptima messenger RNA human papillomavirus test (AHPV) to support the safety of extended screening intervals. RNA-based extended interventional nucleic acid (REINA) provides relevant information on the clinical performance of AHPV.

methodsThis is a longitudinal prospective analysis of 1538 participants after AHPV and liquid-based cytology (LBC) co-test complemented with REINA interventional protocol with a second co-test 4 years after negative screening on 2000 women. Diagnostic accuracy and cumulative risks for CIN2+ up to 9 years were calculated for all test combinations.

resultsSensitivity and specificity for CIN2+ were 96.9% and 88.0% for AHPV and 72.3% and 92.0% for LBC. Negative predictive value (NPV) and positive predictive value (PPV) of AHPV were 99.9% and 23.6%. The 5- and 9-year risks of AHPV-negative women were 0.4% and 1.0% (CIN2+) and 0.3% and 0.7% (CIN3+), a 73% and 64% lower risk than with negative LBC (p ≤ .002). REINA participants with an AHPV-positive result at second co-test after a negative AHPV in first round had a significantly lower 5-year risk of CIN2+ (11.1%) than AHPV-positive women with unknown HPV history (29.5%).

conclusionsCurrently, this constitutes the longest European longitudinal study with AHPV testing in screening population. It reveals 99.9% NPV and a significant protective effect of a previous negative test 5 years after a new HPV infection. These findings support the safety of Aptima for screening intervals beyond 5 years. The risk of disease is lower 9 years after a negative AHPV test than 3 years after a negative LBC. High specificity and PPV of Aptima may benefit controlling overtreatment and colposcopy referrals.

Indexed as

Early Detection of CancerPapillomavirus InfectionsRNA, ViralUterine Cervical DysplasiaUterine Cervical NeoplasmsAdultFemaleFollow-Up StudiesHumansLongitudinal StudiesMiddle AgedPapillomaviridaeProspective StudiesRNA, MessengerSensitivity and SpecificityVaginal SmearsRNA, MessengerRNA, Viralcervical cancerclinical performancelongitudinal studymRNA‐based HPV testingpredictive valuesREINA

Identifiers

PMID39158405
PMCPMC11610794

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

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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 Socratic graph.