Assessment of clinical performance of an ultrasensitive nanowire assay for detecting human papillomavirus DNA in urine.
Gynecol Oncol
; 156(3): 641-646, 2020 03.
Article
em En
| MEDLINE
| ID: mdl-31926639
ABSTRACT
OBJECTIVE:
To evaluate whether HPV DNA in urine has potential advantages as an alternative biomarker for HPV-based cervical cancer screening.METHODS:
Among patients with Cobas HPV test results, a total of 67 HPV-positive (n = 42) and -negative (n = 25) women who agreed to participate in this study were willing to provide paired cervical and urine samples, and we observed concordance between sample types from each patient in identifying HPV genotypes using the nanowire assay.RESULTS:
We detected high-risk strains of HPV DNA in unprocessed urine specimens using polyethyleneimine-conjugated nanowires (PEI-NWs). Concordance for high-risk HPV (hrHPV) between paired urine and cervical samples was 90.4% (κ = 0.90; 95% CI 0.80-100.00). The virological sensitivity and specificity for detection of HPV DNA from a small urine sample (200 µL) were 81.3% (κ = 0.83; 95% CI 62.1-100.0) and 98.0% (κ = 0.83; 95% CI 94.2-100.0) for HPV16 group, 100.0% (κ = 0.65; 95% CI 100.0-100.0) and 95.3% (κ = 0.65; 95% CI 90.1-100.0) for HPV18 group, and 96.4% (κ = 0.97; 95% CI 89.6-100.0) and 100.0% (κ = 0.97; 95% CI 100.0-100.0) for other hrHPV group, respectively.CONCLUSIONS:
The nanowire assay demonstrated excellent ability to identify HPV DNA from urine specimens. We observed an excellent agreement in the detection of high-risk HPV between paired urine and cervical samples, even with small urine sample volume.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Papillomaviridae
/
DNA Viral
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Neoplasias do Colo do Útero
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Infecções por Papillomavirus
Tipo de estudo:
Diagnostic_studies
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Screening_studies
Limite:
Female
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Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article