Estudo mostra que técnica de imunocitoquímica é mais específica para detectar HPV


Uma ferramenta para testagem e diagnóstico baseada na detecção de uma proliferação de marcadores combina alta sensibilidade e alta especificidade para encontrar doenças cervicais em alto grau e em um só teste, de acordo com estudo publicado no American Journal of Clinical Pathology em 17 de junho de 2010.

O p16 imunocitoquímica se mostra com performance clínica superior para detectar o Papiloma Vírus Humano de alto risco (HPV-HR), que ajuda na identificação de neoplasia cervical intraepitelial de alto grau (CIN) contida em testes como Papanicolau, por exemplo. As duas categorias de citologia de Papanicolau são particularmente difíceis de interpretar porque, mesmo que a maioria dos casos seja benigna, mais de 15% das mulheres com tal citologia apresentam um alto grau de neoplasia cervical intraepitelial, precursora imediata do câncer cervical.

Dois kits contendo um anticorpo especificamente designado (clone E6H4TM) e reagentes secundários customizados com protocolos foram desenvolvidos e otimizados para aplicações imunoquímicas em histologia cervical (CINtec Histology) e espécies citológicas (CINtec Citology). Um novo kit, lançado recentemente, o CINtec Plus é um ferramenta para diagnóstico e testagem baseada na codetecção do p16 com Ki-67 (um marcador de proliferação) que combina alta sensibilidade e alta especificidade para detectar doença cervical em alto grau em um único teste.

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Integra matéria

Immunocytochemistry More Specific Than HPV Testing
By Labmedica International staff writers
Posted on 29 Jun 2010

A screening and diagnostic tool that is based on the co-detection of a proliferation marker combines high sensitivity and high specificity for detecting high-grade cervical disease in a single test.
p16 immuno-cytochemistry shows superior clinical performance to High-risk Human Papillomavirus (HR-HPV) testing for the identification of high-grade cervical intraepithelial neoplasia (CIN) harbored in Atypical Squamous Cells of Undetermined Significance (ASC-US) and Low-grade Squamous Intraepithelial Lesion (LSIL) Papanicolau test (Pap) cytology cases.

The two Pap cytology categories are particularly difficult to interpret because although the majority of cases are benign, up to 15 % of women with such a cytology result harbor high-grade CIN disease, the immediate pre-cursor to cervical cancer.

Two kits contain a specifically designed antibody (clone E6H4TM) and customized secondary reagents with protocols, developed and optimized for immunochemistry applications in cervical histology (CINtec Histology) and cytology specimens (CINtec Cytology). A newly launched kit, CINtec PLUS is a screening and diagnostic tool based on the codetection of p16 plus Ki-67 (a proliferation marker) that combines high sensitivity and high specificity for detecting high-grade cervical disease in a single test.

The performance of p16INK4a immuno-cytochemistry (p16 Cytology) and HPV testing was analyzed on a series of 810 retrospectively collected ASC-US and LSIL cases. The sensitivity (ability to find established disease) of the two tests was similar. However, the specificity of p16 Cytology was up to two times higher than that of HPV testing. This means that significantly fewer women would need to be sent on for further diagnostic follow-up, while still being able to identify those with established high-grade disease.

The study was published in the American Journal of Clinical Pathology on June 17, 2010.

mtm laboratories AG (Heidelberg, Germany) is a certified developer and manufacturer of in vitro diagnostic devices for use in the early detection and diagnosis of cervical cancer. Its family of products is based on the E6H4TM antibody clone, which was specifically developed for immunochemistry applications in cervical histology and cytology specimens. The target for mtm"s cervical cancer early detection technology platforms is the evaluation of the overexpression of the cyclin-dependent kinase inhibitor p16INK4a. The overexpression of this biomarker is directly correlated to the oncogenic activity of HR-HPV that marks the generation of cervical cancer.

Related Links:
mtm laboratories AG



Published: 4/10/2015

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