Evidence map›Paper›PMID 31978559›Full record

ArticleThe Journal of molecular diagnostics : JMD2020

An Isothermal, Multiplex Amplification Assay for Detection and Genotyping of Human Papillomaviruses in Formalin-Fixed, Paraffin-Embedded Tissues.

Yi-Wei Tang, Lorena Lozano, Xin Chen, Troy D Querec, Nora Katabi, Antonio Moreno-Docón, Hongmei Wang, Daniel Fix, Louise De Brot, Tracy A McMillen and 5 more

Open access · greenAbstract read
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
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

22 citing papers in PubMed, 43 citations in OpenAlex.

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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

15 authors at 4 institutions in 5 countries.

Yi-Wei TangDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, New York. Electronic address: yi-wei.tang@cepheid.com.
Lorena LozanoDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Genetics and Microbiology, Universidad de Murcia, Murcia, Spain.
Xin ChenAtila Biosystems Inc., Mountain View, California.
Troy D QuerecNational Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Nora KatabiDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Antonio Moreno-DocónDepartment of Genetics and Microbiology, Universidad de Murcia, Murcia, Spain; Department of Microbiology, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
Hongmei WangDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Infectious Diseases, Shenzhen Children Hospital, Shenzhen, People's Republic of China.
Daniel FixDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Pathology, Hackensack University Medical Center, Hackensack, New Jersey.
Louise De BrotDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Pathology, A.C. Camargo Cancer Center, Sao Paolo, Brazil.
Tracy A McMillenDepartment of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Ju-Yoon YoonDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
Amparo TorrobaDepartment of Pathology, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
Youxiang WangAtila Biosystems Inc., Mountain View, California.
Elizabeth R UngerNational Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Kay J ParkDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Memorial Sloan Kettering Cancer Center · USCenters for Disease Control and Prevention · USHospital Universitario Virgen de la Arrixaca · ESHackensack University Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Rapid and accurate identification of human papillomavirus (HPV) is important for both clinical management and population screening. Analytic validation of Atila AmpFire Multiplex HPV assays on formalin-fixed, paraffin-embedded (FFPE) cervix/vulva and oropharynx diagnostic tissue samples was performed. The AmpFire assay incorporates a novel isothermal multiplex amplification coupled with real-time fluorescent detection to detect and genotype 15 high-risk (HR) HPV genotypes. Limits of detection determined by plasmids cloned with HPV genotype-specific sequences were 2 copies/reaction for HPV16, HPV18, and some HR HPV genotypes, and 20 copies/reaction for the remaining HR HPV genotypes. The performance of the AmpFire assays in clinical samples was evaluated using 214 FFPE specimens. The AmpFire assay failed in one clinical specimen for an invalid rate of 0.5%. The AmpFire assay detected HPV in clinical samples with positive percent agreements of 100.0% for HPV16, 100.0% for HPV18, and 94.7% for non-16/18 HR HPV, and 100% negative percent agreements for HPV16, HPV18, and non-16/18 HR HPV. Qualitative detection agreement was obtained in the reproducibility study. In summary, the Atila AmpFire HPV assay demonstrated excellent analytic sensitivity and specificity for detection and genotyping of 15 HR HPV genotypes. Assay parameters of simple specimen processing, small sample size requirement, rapid turnaround time, and being near instrument-free render it well suited for HPV detection and genotyping in FFPE specimens.

Indexed as

GenotypeGenotyping TechniquesAlphapapillomavirusFemaleHumansMultiplex Polymerase Chain ReactionPapillomavirus InfectionsParaffin EmbeddingReagent Kits, DiagnosticReproducibility of ResultsSensitivity and SpecificityReagent Kits, Diagnostic

Identifiers

PMID31978559
PMCPMC7081142
OpenAlexW3000923460

What OpenQuestion holds

Textmetadata
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.