Evidence map›Paper›PMID 42252568›Full record

ArticleInternational journal of cancer2026

Clinical Validation of Four Point-of-Care High-Risk HPV Assays, Including Two Reduced-Valency Assays, for Cervical Cancer Screening in Low-Resource Settings.

Neerja Bhatla, MaryLuz Rol, Seema Singhal, Showket Hussain, Anushree Patil, Pranay Tanwar, Shalini Singh, Vikrant M Bhor, Kiran Munne, Richa Vashishtha and 19 more

Abstract readValidation Study
In one paragraph

Article in International journal of cancer, 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

29 authors.

Neerja BhatlaAll India Institute of Medical Sciences, New Delhi, India.
MaryLuz RolEarly Detection, Prevention & Infections Branch, International Agency for Research on Cancer, Lyon, France.ORCID https://orcid.org/0000-0003-4250-092X
Seema SinghalAll India Institute of Medical Sciences, New Delhi, India.
Showket HussainICMR-National Institute of Cancer Prevention and Research, Noida, India.
Anushree PatilICMR-National Institute for Research on Women's Health (ICMR-NIRWoH), Formerly ICMR-NIRRCH, Mumbai, India.
Pranay TanwarAll India Institute of Medical Sciences, New Delhi, India.
Shalini SinghICMR-National Institute of Cancer Prevention and Research, Noida, India.
Vikrant M BhorICMR-National Institute for Research on Women's Health (ICMR-NIRWoH), Formerly ICMR-NIRRCH, Mumbai, India.
Kiran MunneICMR-National Institute for Research on Women's Health (ICMR-NIRWoH), Formerly ICMR-NIRRCH, Mumbai, India.ORCID https://orcid.org/0000-0001-7077-5854
Richa VashishthaBiotechnology Industry Research Assistance Council, Department of Biotechnology, New Delhi, India.
Shachi VashistAll India Institute of Medical Sciences, New Delhi, India.
Eric LucasEarly Detection, Prevention & Infections Branch, International Agency for Research on Cancer, Lyon, France.
Richard MuwongeEarly Detection, Prevention & Infections Branch, International Agency for Research on Cancer, Lyon, France.
Arianis Tatiana RamírezEarly Detection, Prevention & Infections Branch, International Agency for Research on Cancer, Lyon, France.
Anju SinghAll India Institute of Medical Sciences, New Delhi, India.
Vikas KhanAll India Institute of Medical Sciences, New Delhi, India.
Jyoti RaniICMR-National Institute of Cancer Prevention and Research, Noida, India.
Nasera FirdausiICMR-National Institute of Cancer Prevention and Research, Noida, India.
Sandeep SisodiyaICMR-National Institute of Cancer Prevention and Research, Noida, India.
Rutuja WakchaureICMR-National Institute for Research on Women's Health (ICMR-NIRWoH), Formerly ICMR-NIRRCH, Mumbai, India.
María Alejandra PicconiInstituto Nacional de Enfermedades Infecciosas - ANLIS Malbrán, Buenos Aires, Argentina.
Alejandro CalderónCaja Costarricense de Seguro Social, San José, Costa Rica.
Margo BellCentre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Annemie De SmetCentre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Alex VorstersCentre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Gary M CliffordEarly Detection, Prevention & Infections Branch, International Agency for Research on Cancer, Lyon, France.ORCID https://orcid.org/0000-0001-7534-333X
Madhavi ChandraBiotechnology Industry Research Assistance Council, Department of Biotechnology, New Delhi, India.
Jitendra KumarBiotechnology Industry Research Assistance Council, Department of Biotechnology, New Delhi, India.
Partha BasuEarly Detection, Prevention & Infections Branch, International Agency for Research on Cancer, Lyon, France.ORCID https://orcid.org/0000-0003-0124-4050

Funding

Gates Foundation INV-061732Research Foundation-Flanders (FWO), Belgium 11PJK24
6 · The paper itself

Abstract

Persistent infection with high-risk human papillomavirus (HR-HPV) is the necessary cause of cervical cancer, with approximately 95% of cases attributable to eight most carcinogenic HPV types (16/18/31/33/35/45/52/58). Several HPV assays have recently been developed in India for use in cervical cancer screening, including reduced-valency tests targeting seven/eight oncogenic HPV types. We evaluated the clinical accuracy and reproducibility of four such assays: PathoDetect-HPV-14, HPV-Q (14 types), Truenat-HR-HPV-Plus (8 types), and PathoDetect-HPV-7 (7 types). Using the VALGENT framework, 1159 cervical samples from the ESTAMPA study conducted in Argentina and Costa Rica were analysed with the new assays. The samples included 97 cases of CIN2+ (19 CIN2, 72 CIN3, and 6 cancers). Assay performance was compared in a blinded manner with established reference tests (Cobas-4800 and Allplex-HPV-HR) and reduced-valency comparators. Sensitivity, specificity, agreement, and repeatability were assessed. Truenat-HR-HPV-Plus demonstrated a sensitivity of 80.4% (95% CI: 71.1-87.8) and specificity of 91.5% (95% CI: 89.5-93.2) for CIN2+. It met IARC validation criteria and showed non-inferior performance to Allplex-HPV-HR-8, with relative sensitivity of 1.03 (95% CI: 0.96-1.09) for CIN2+ and 1.00 (95% CI: 0.96-1.04) for CIN3+, and relative specificity of 0.99 (95% CI: 0.97-1.00) and 0.98 (95% CI: 0.97-1.00), respectively. Repeatability was 93.3% (κ = 0.79). PathoDetect-HPV-7 showed lower sensitivity (68.1%) with specificity of 89.0%. HPV-Q and PathoDetect-HPV-14 did not meet validation criteria. This study represents the first formal validation of reduced-valency HPV assays and demonstrates that Truenat-HR-HPV-Plus provides robust clinical performance with higher specificity than 14-valent assays, supporting its potential to improve screening efficiency and reduce unnecessary referrals.

Indexed as

Early Detection of CancerHuman Papillomavirus VirusesPapillomaviridaePapillomavirus InfectionsUterine Cervical DysplasiaUterine Cervical NeoplasmsAdultArgentinaCosta RicaDNA, ViralFemaleHumansMiddle AgedRapid Diagnostic TestsReproducibility of ResultsResource-Limited SettingsDNA, Viralcervical cancer screeningclinical validationhigh‐risk HPV assayslow‐resource settings

Identifiers

PMID42252568
PMCPMC13495801

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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 OpenQuestion graph.