Cintec plus cytology test

  • What is a CINtec test?

    The CINtec PLUS Cytology test is the only FDA approved triage test that uses dual biomarker technology to simultaneously detect p16 and Ki-67 in women with HPV-positive results..

  • Which of the following clinical trials assessed the CINtec plus cytology test?

    The regulatory decision was based on findings from the registrational IMPACT trial, for which publication of the full data is pending, according to Roche.
    In the trial, investigators examined the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of over 35,000 women..

The CINtec® PLUS Cytology test is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical specimens collected by a clinician using an endocervical brush/spatula or broom collection device and placed in the ThinPrep® Pap Test PreservCyt® Solution.

Can Cintec plus cytology be used on Cobas® 4800/6800/8800 instruments?

CINtec PLUS Cytology is approved for use on cobas® 4800/6800/8800 instruments.
Included cobas® HPV test, CINtec PLUS Cytology test, and CINtec ® Histology Multicenter, prospective trial enrolling ~35,000 women at 32 collection sites across the US .

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Does Cintec plus cytology Ki 67 bind to a recombinant protein?

The CINtec PLUS Cytology Ki-67 primary antibody (274-11AC3V1) bound to a purified recombinant Ki-67 protein fragment and not to an equivalent amount of the unrelated recombinant negative control protein.
Binding in this assay was not detected in the Ki-67 low-expressing cell line LNCaP.

,

What is Cintec plus cytology test?

The CINtec® PLUS Cytology test is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical specimens collected by a clinician using an endocervical brush/spatula or broom collection device and placed in the ThinPrep® Pap Test PreservCyt® Solution.


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