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Clinical Performance of the CLART Human Papillomavirus 2 Assay Compared With the Hybrid Capture 2 Test
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Advisor(s)
Abstract(s)
Persistent infection by high-risk human papillomavirus (HR-HPV) is a cause of cervical cancer. The use
of HPV detection in cervical screening programs
may improve the ability to identify women at risk
of cervical cancer. Therefore, the development of
appropriate methods for the detection of HR-HPV
is essential. The aim of this study was to evaluate
the clinical performance of the CLART Human
Papillomavirus 2 assay (CLART) in comparison
with the Hybrid Capture 2 test (HC2), using a clinical
cut-off of cervical intraepithelial neoplasia grade
2 or worse. Discrepant results were analyzed
further by the PapilloCheck HPV genotyping system. In the 425 studied women, HR-HPV positivity
rates were similar by both tests (CLART-13 HR-HPV:
63.1%; CLART-17 HR-HPV: 64.7%; HC2: 64.5%).
Agreement between CLART-13 HR-HPV (k¼ 0.969;
concordance level 98.6%), CLART-17 HR-HPV
(k¼ 0.974; concordance level 98.8%), and HC2 were
very good. When 13 HR-HPV types were considered, the two tests showed a clinical sensitivity of
96% (95% CI: 92.6–97.9). The clinical specificity of
CLART-13 HR-HPV was 73.6% (95% CI: 66.7–79.5)
for cervical intraepithelial neoplasia grade 2 or
worse, which was comparable to HC2 (71.4%;
95% CI: 64.3–77.5). When all 17 HR-HPV types
were considered, CLART showed a clinical sensitivity of 96.9% (95% CI: 93.8–98.5) and a clinical
specificity of 71.9% (95% CI: 64.9–78.0). In conclusion, the CLART assay is efficient, sensitive,
reproducible, and has a similar performance to
HC2 for cervical intraepithelial neoplasia grade 2
or worse. Furthermore, this assay has the advantage of detecting and genotyping 35 HPV types by
a single test, which can provide additional
information on the predictive value of infection
with HR-HPV
Description
Keywords
Infecções Sexualmente Transmissíveis Tecnologias de Análise de DNA Clinical Performance CLART Human Papillomavirus 2 Assay Hybrid Capture 2 HPV Human Papillomavirus HPV Genotyping Genomica
Pedagogical Context
Citation
J Med Virol. 2011 Feb;83(2):272-6