- Vysis FISH
- Abbott REAL-TIME PCR
- Ordering Information
AneuVysion, which utilizes patented fluorescence in situ hybridization (FISH) technology applied to uncultured amniocytes, provides detection of trisomies 13, 18, and 21 (Down syndrome) and sex chromosome aneusomies in as little as 24 hours. Together these conditions account for nearly twothirds 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% accurate for the detection of trisomies 13, 18, 21, and aneusomies of X and Y. There are several benefits of the AneuVysion Test. Results are rapidly available, within 24 hours after the amniocentesis sample is received in the laboratory (rather than 7-22 days for routine chromosome analysis). In accordance with professional standards, the availability of AneuVysion results along with consistent clinical information (i.e., fetal anomalies detected by ultrasonography) allows for pregnancy management options that otherwise might not be available due to late gestational age. Finally, in the rare case of a culture failure when standard cytogenetic results cannot be obtained, information on chromosome number for the most likely aneusomies is available.
PROBE MIXTURE #1
PROBE MIXTURE #2
Mixture #1 is complete with labeled probes and non-labeled blocking DNA in hybridization buffer.INTENDED USE
For In Vitro Diagnostic Use
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 fl uorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from amniotic fl uid 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 . 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.LIMITATIONS
Warnings and Precautions
To learn more about AneuVysion please visit: https://www.molecular.abbott/us/en/products/genetics-genomics/aneuvysion-multicolor-dna-probe-kit
Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.
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.