Evidence map›Paper›PMID 41989210›Full record

ArticleJournal of medical virology2026

Mock Samples That Mimic Human Cervicovaginal Samples to Accelerate the Development and Evaluation of Assays for High-Risk HPV for Cervical Cancer Screening.

Emilie Newsham Novak, Ariel Ma, Cannon J Hansen, Zoha Wazir, Meaghan Bond, Michael E Scheurer, Ming Guo, Mila P Salcedo, Kathleen M Schmeler, Rebecca R Richards-Kortum

Abstract readEvaluation Study
In one paragraph

Article in Journal of medical virology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

10 authors.

Emilie Newsham NovakDepartment of Bioengineering, Rice University, Houston, TX, USA.
Ariel MaDepartment of Bioengineering, Rice University, Houston, TX, USA.
Cannon J HansenDepartment of Bioengineering, Rice University, Houston, TX, USA.
Zoha WazirDepartment of Bioengineering, Rice University, Houston, TX, USA.
Meaghan BondDepartment of Bioengineering, Rice University, Houston, TX, USA.
Michael E ScheurerDepartment of Pediatrics, Division of Hematology/Oncology, Emory University School of Medicine, Atlanta, GA, USA.
Ming GuoDepartment of Anatomical Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID https://orcid.org/0000-0002-6773-1145
Mila P SalcedoDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Kathleen M SchmelerDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rebecca R Richards-KortumDepartment of Bioengineering, Rice University, Houston, TX, USA.

Funding

Sample-to-answer HPV DNA nucleic acid test for cervical cancer screening in MozambiqueU01CA292741 · NCI · RICE UNIVERSITY · PI CESALTINA FERREIRA LORENZONI, Jane R Montealegre · 2024 to 2026
$1.8M
Point-of-care HPV mRNA test for cervical cancer screening in low-resource settingsR21CA249367 · NCI · RICE UNIVERSITY · PI RICHARDS-KORTUM, REBECCA R. · 2021 to 2022
$418k
Human papillomavirus mRNA detection for assessing cervical cancer risk in resource-limited settingsF99CA294262 · NCI · RICE UNIVERSITY · PI NOVAK, EMILIE NEWSHAM · 2024 to 2024
$50k
National Cancer Institute of the National Institutes of Health F99CA294262National Cancer Institute of the National Institutes of Health R21CA249367National Cancer Institute of the National Institutes of Health U01CA292741NCI NIH HHS F99 CA294262NCI NIH HHS R21 CA249367NCI NIH HHS U01 CA292741
6 · The paper itself

Abstract

Nearly all cervical cancer cases are caused by high-risk human papillomavirus (hrHPV) infections. The World Health Organization recommends screening for hrHPV using nucleic acid amplification tests (NAATs) that detect hrHPV DNA or mRNA. Lack of access to affordable, point-of-care screening tests in resource-limited settings leads to women presenting with advanced-stage cervical cancer, with many dying of the disease. There is a significant need to develop point-of-care NAATs to improve screening and early detection. Because access to real clinical samples is limited, initial evaluation of NAATs is often performed using contrived samples created using some combination of extracted hrHPV DNA and/or cultured hrHPV-positive cells. When mock samples do not adequately recapitulate the contents of clinical cervicovaginal samples, it can delay clinical translation of potentially promising assays. To improve the value of contrived samples, we characterized the composition of 32 hrHPV DNA-positive cervicovaginal clinical samples. We also describe a simple method to generate contrived samples that mimic the diversity of clinical cervicovaginal samples, and test them using the methods used to characterize the clinical samples. Results show that the hrHPV DNA content of cervicovaginal samples varies by approximately eight orders of magnitude and spans from 100% linear integrated DNA to 100% circular non-integrated DNA, that the concentration of hrHPV mRNA also varies by nearly nine orders of magnitude between patient samples, and that the concentration of potential inhibitors such as hemoglobin varies by more than three orders of magnitude. hrHPV DNA and mRNA extracted from contrived samples exhibited expected patterns of DNA quantity, DNA conformation, and mRNA quantity. Altogether, the protocols described here to generate mock samples can help NAAT developers optimize test performance prior to clinical evaluation, potentially improving test performance and reducing time to deployment.

Indexed as

Cervix UteriEarly Detection of CancerHuman Papillomavirus VirusesMolecular Diagnostic TechniquesPapillomaviridaePapillomavirus InfectionsUterine Cervical NeoplasmsVaginaDNA, ViralFemaleHumansMass ScreeningDNA, Viral

Identifiers

PMID41989210
PMCPMC13085960

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.