Statistical Modeling for Quality Assurance of Human Papillomavirus DNA Batch Testing.
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 ANDMETHODS:
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Papillomaviridae
/
Garantia da Qualidade dos Cuidados de Saúde
/
Manejo de Espécimes
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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