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For In Vitro Diagnostic Use
The AneuVysion Multicolor DNA Probe Kit (Vysis CEP 18/X/Y - alpha satellite / LSI 13/21), which utilizes patented 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.
AneuVysion Multicolor DNA Probe Kit Package Insert (PDF - 1.5 MB) For Information Only - Not a Controlled Copy
Together, trisomies 13, 18, and 21 (Down syndrome) and sex chromosome aneusomies account for nearly two-thirds 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.
Aneuvysion Test Benefits
Because the 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), patients can benefit psychologically from a shorter time period of uncertainty. An expected AneuVysion result may allow patients a sense of relief in knowing that the majority of chromosome abnormalities for which their fetus was at risk have been ruled out with a very high degree of accuracy. Importantly, 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.
AneuVysion Kit Contents
Each AneuVysion kit includes:
Both Mixture #1 and Mixture #2 are complete with labeled probes and non-labeled blocking DNA in hybridization buffer.
Indications and Limitations of 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 fluorescence in situ hybridization (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 . 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.
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.
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