A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test

Hannah P. Yang; David K. Walmer; Delson Merisier; Julia C. Gage; Laura Bell; Sameera Rangwala; Niwashin Shrestha; Lori Kobayashi; Paul S. Eder; Philip E. Castle

doi:10.1016/j.jviromet.2011.05.024

A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test

Hannah P. Yang, David K. Walmer, Delson Merisier, Julia C. Gage, Laura Bell, Sameera Rangwala, Niwashin Shrestha, Lori Kobayashi, Paul S. Eder, Philip E. Castle

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

The analytic performance of a low-cost, research-stage DNA test for the most carcinogenic human papillomavirus (HPV) genotypes (HPV16, HPV18, and HPV45) in aggregate was evaluated among carcinogenic HPV-positive women, which might be used to decide who needs immediate colposcopy in low-resource settings (" triage test"). We found that HPV16/18/45 test agreed well with two DNA tests, a GP5+/6+ genotyping assay (Kappa = 0.77) and a quantitative PCR assay (at a cutpoint of 5000 viral copies) (Kappa = 0.87). DNA sequencing on a subset of 16 HPV16/18/45 positive and 16 HPV16/18/45 negative verified the analytic specificity of the research test. It is concluded that the HPV16/18/45 assay is a promising triage test with a minimum detection of approximately 5000 viral copies, the clinically relevant threshold.

Original language	English (US)
Pages (from-to)	112-114
Number of pages	3
Journal	Journal of Virological Methods
Volume	176
Issue number	1-2
DOIs	https://doi.org/10.1016/j.jviromet.2011.05.024
State	Published - Sep 2011
Externally published	Yes

Keywords

Cervical cancer
HPV genotypes
HPV test
Human papillomavirus (HPV)

ASJC Scopus subject areas

Virology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jviromet.2011.05.024

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title = "A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test",

abstract = "The analytic performance of a low-cost, research-stage DNA test for the most carcinogenic human papillomavirus (HPV) genotypes (HPV16, HPV18, and HPV45) in aggregate was evaluated among carcinogenic HPV-positive women, which might be used to decide who needs immediate colposcopy in low-resource settings ({"} triage test{"}). We found that HPV16/18/45 test agreed well with two DNA tests, a GP5+/6+ genotyping assay (Kappa = 0.77) and a quantitative PCR assay (at a cutpoint of 5000 viral copies) (Kappa = 0.87). DNA sequencing on a subset of 16 HPV16/18/45 positive and 16 HPV16/18/45 negative verified the analytic specificity of the research test. It is concluded that the HPV16/18/45 assay is a promising triage test with a minimum detection of approximately 5000 viral copies, the clinically relevant threshold.",

keywords = "Cervical cancer, HPV genotypes, HPV test, Human papillomavirus (HPV)",

author = "Yang, {Hannah P.} and Walmer, {David K.} and Delson Merisier and Gage, {Julia C.} and Laura Bell and Sameera Rangwala and Niwashin Shrestha and Lori Kobayashi and Eder, {Paul S.} and Castle, {Philip E.}",

note = "Funding Information: The evaluation of the HPV16/18/45 triage test data was conducted for research purposes and was supported in part by the intramural research program of the NIH/NCI . The authors would like to recognize Adam Mallonee of QIAGEN for his contribution to performing the genotyping tests.",

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doi = "10.1016/j.jviromet.2011.05.024",

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AU - Yang, Hannah P.

AU - Walmer, David K.

AU - Merisier, Delson

AU - Gage, Julia C.

AU - Bell, Laura

AU - Rangwala, Sameera

AU - Shrestha, Niwashin

AU - Kobayashi, Lori

AU - Eder, Paul S.

AU - Castle, Philip E.

N1 - Funding Information: The evaluation of the HPV16/18/45 triage test data was conducted for research purposes and was supported in part by the intramural research program of the NIH/NCI . The authors would like to recognize Adam Mallonee of QIAGEN for his contribution to performing the genotyping tests.

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N2 - The analytic performance of a low-cost, research-stage DNA test for the most carcinogenic human papillomavirus (HPV) genotypes (HPV16, HPV18, and HPV45) in aggregate was evaluated among carcinogenic HPV-positive women, which might be used to decide who needs immediate colposcopy in low-resource settings (" triage test"). We found that HPV16/18/45 test agreed well with two DNA tests, a GP5+/6+ genotyping assay (Kappa = 0.77) and a quantitative PCR assay (at a cutpoint of 5000 viral copies) (Kappa = 0.87). DNA sequencing on a subset of 16 HPV16/18/45 positive and 16 HPV16/18/45 negative verified the analytic specificity of the research test. It is concluded that the HPV16/18/45 assay is a promising triage test with a minimum detection of approximately 5000 viral copies, the clinically relevant threshold.

AB - The analytic performance of a low-cost, research-stage DNA test for the most carcinogenic human papillomavirus (HPV) genotypes (HPV16, HPV18, and HPV45) in aggregate was evaluated among carcinogenic HPV-positive women, which might be used to decide who needs immediate colposcopy in low-resource settings (" triage test"). We found that HPV16/18/45 test agreed well with two DNA tests, a GP5+/6+ genotyping assay (Kappa = 0.77) and a quantitative PCR assay (at a cutpoint of 5000 viral copies) (Kappa = 0.87). DNA sequencing on a subset of 16 HPV16/18/45 positive and 16 HPV16/18/45 negative verified the analytic specificity of the research test. It is concluded that the HPV16/18/45 assay is a promising triage test with a minimum detection of approximately 5000 viral copies, the clinically relevant threshold.

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A pilot analytic study of a research-level, lower-cost human papillomavirus 16, 18, and 45 test

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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