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The AneuVysion Multicolor DNA Probe Kit (Vysis CEP 18/X/Y - alpha satellite / LSI 13/21), which utilizes fluorescence in situ hybridization (FISH) technology applied to uncultured or cultured amniocytes, provides detection of trisomies 13, 18, and 21 (Down syndrome) and sex chromosome aneusomies in as little as 24 hours.
For In Vitro Diagnostic Use
Product is not available where CE certification is required
Together, trisomies 13, 18, and 21 (Patau’s, Edwards and Down syndrome) and sex chromosome aneusomies account for 57% of all abnormalities identified at the time of amniocentesis, and 85-90% of clinically significant chromosomal abnormalities detected in live-born infants. Review of AneuVysion testing of over 29,000 amniotic fluid samples has found that the test is 99.9% specific with 99.6% sensitivity for the detection of trisomies 13, 18, 21, Klinefelter and Turner syndrome, and aneusomies of X and Y.
AneuVysion Kit Contents
Each AneuVysion kit includes:
CEP 18/X/Y and LSI 13/21 are pre-mixed with Blocking DNA and Hybridization Buffer.
The AneuVysion (Vysis CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21q22.13 to 21q22.2 region. The AneuVysion kit is indicated for identifying and enumerating chromosomes 13, 18, 21, X, and Y via FISH in metaphase cells and interphase nuclei obtained from amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for making clinical decisions. FISH results are intended to be used as an aid in the diagnosis of numerical abnormalities of chromosomes 13, 18, 21, X and/or Y in conjunction with other information currently used in prenatal diagnosis, consistent with professional standards of practice.1 This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not detect the presence of structural chromosome abnormalities that can also result in birth defects. This FISH assay will be performed in cytogenetics laboratories.
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.
