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Statistical Modeling for Quality Assurance of Human Papillomavirus DNA Batch Testing.
Beylerian, Emily N; Slavkovsky, Rose C; Holme, Francesca M; Jeronimo, Jose A.
Afiliação
  • Beylerian EN; PATH, Seattle, WA.
  • Slavkovsky RC; PATH, Seattle, WA.
  • Holme FM; PATH, Seattle, WA.
  • Jeronimo JA; Global Coalition Against Cervical Cancer, Arlington, VA.
J Low Genit Tract Dis ; 22(3): 219-224, 2018 Jul.
Article em En | MEDLINE | ID: mdl-29570137
ABSTRACT

OBJECTIVES:

Our objective was to simulate the distribution of human papillomavirus (HPV) DNA test results from a 96-well microplate assay to identify results that may be consistent with well-to-well contamination, enabling programs to apply specific quality assurance parameters. MATERIALS AND

METHODS:

For this modeling study, we designed an algorithm that generated the analysis population of 900,000 to simulate the results of 10,000 microplate assays, assuming discrete HPV prevalences of 12%, 13%, 14%, 15%, and 16%. Using binomial draws, the algorithm created a vector of results for each prevalence and reassembled them into 96-well matrices for results distribution analysis of the number of positive cells and number and size of cell clusters (≥2 positive cells horizontally or vertically adjacent) per matrix.

RESULTS:

For simulation conditions of 12% and 16% HPV prevalence, 95% of the matrices displayed the following characteristics 5 to 17 and 8 to 22 total positive cells, 0 to 4 and 0 to 5 positive cell clusters, and largest cluster sizes of up to 5 and up to 6 positive cells, respectively.

CONCLUSIONS:

Our results suggest that screening programs in regions with an oncogenic HPV prevalence of 12% to 16% can expect 5 to 22 positive results per microplate in approximately 95% of assays and 0 to 5 positive results clusters with no cluster larger than 6 positive results. Results consistently outside of these ranges deviate from what is statistically expected and could be the result of well-to-well contamination. Our results provide guidance that laboratories can use to identify microplates suspicious for well-to-well contamination, enabling improved quality assurance.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Papillomaviridae / Garantia da Qualidade dos Cuidados de Saúde / Manejo de Espécimes / DNA Viral / Infecções por Papillomavirus / Técnicas de Diagnóstico Molecular / Detecção Precoce de Câncer Tipo de estudo: Diagnostic_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Limite: Adult / Female / Humans / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Papillomaviridae / Garantia da Qualidade dos Cuidados de Saúde / Manejo de Espécimes / DNA Viral / Infecções por Papillomavirus / Técnicas de Diagnóstico Molecular / Detecção Precoce de Câncer Tipo de estudo: Diagnostic_studies / Prevalence_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Limite: Adult / Female / Humans / Middle aged Idioma: En Ano de publicação: 2018 Tipo de documento: Article