Evidence map›Paper›PMID 41459933›Full record

ArticleJournal of clinical microbiology2026

Performance of a novel, urine-based test for the detection of cervical human papillomavirus infection.

Sharmila Manjeshwar, Noah Kojima, Eric Tsang, David Pereira, Emmanuel Silva, Ha Duong, Felix Chao, Daniel R Marshak, Ricky Y T Chiu, Jeffrey D Klausner

Abstract readEvaluation Study
In one paragraph

Article in Journal of clinical microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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.

Sharmila ManjeshwarPhase Scientific Americas, Garden Grove, California, USA.ORCID 0009-0005-6404-2933
Noah KojimaDepartment of Medicine, University of California Los Angeles, Los Angeles, California, USA.ORCID 0000-0002-3667-9719
Eric TsangPhase Scientific Americas, Garden Grove, California, USA.
David PereiraPhase Scientific Americas, Garden Grove, California, USA.
Emmanuel SilvaPhase Scientific Americas, Garden Grove, California, USA.
Ha DuongPhase Scientific Americas, Garden Grove, California, USA.
Felix ChaoPhase Scientific Americas, Garden Grove, California, USA.
Daniel R MarshakPhase Scientific Americas, Garden Grove, California, USA.
Ricky Y T ChiuPhase Scientific International Ltd., Sha Tin, Hong Kong.ORCID 0000-0003-4742-4495
Jeffrey D KlausnerKeck School of Medicine, University of Southern California, Los Angeles, California, USA.ORCID 0000-0002-6922-7364

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cervical cancer screening using the Pap smear is limited by invasive sampling and low participation among select populations. As human papillomavirus (HPV) is the leading cause of cervical cancer, urine-based testing offers a non-invasive alternative with the potential to increase overall screening participation. We developed and evaluated the performance of the Phase HPV Urine Test, a qualitative real-time PCR assay for the detection of 14 high-risk HPV (HR-HPV) subtypes in first-void urine samples. The assay utilizes a proprietary, room-temperature-stable sample collection system and a novel PHASiFY DNA extraction system optimized for large-volume (40 mL) urine processing. The analytical performance was evaluated to determine accuracy, precision, limit of detection (LOD), cross-reactivity, interference, and sample stability. Analytical performance was also assessed using 128 paired urine and clinician-collected cervical specimens (cervical broom in BD SurePath) tested with the Roche cobas 4800 HPV Test as the reference assay. The assay demonstrated 82.3% initial overall percent agreement with the cobas 4800 HPV test, improving to 93% after adjudication with HPV next-generation sequencing. The assay exhibited high precision (≥97.7%), a low LOD (15-30 viral copies/mL), interference with

Indexed as

Molecular Diagnostic TechniquesPapillomaviridaePapillomavirus InfectionsUrineUterine Cervical NeoplasmsAdultCervix UteriDNA, ViralEarly Detection of CancerFemaleHumansLimit of DetectionMiddle AgedReal-Time Polymerase Chain ReactionSensitivity and SpecificitySpecimen HandlingDNA, Viralhigh-risk HPVPHASiFY technologyreal-time PCRself-collectionurine

Identifiers

PMID41459933
PMCPMC12893011

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.