AneuSure®

The AneuSure® QF-PCR Diagnostic Testing kit is used for rapid prenatal diagnosis of chromosomal aneuploidies including Trisomy 21 (Down Syndrome or +21), Trisomy 18 (Edwards Syndrome or +18), Trisomy 13 (Patau Syndrome or +13) as well as for 47, XXY (Klinefelter Syndrome), 47, XXX (Triple X Syndrome), 45, X (Turner Syndrome) and other sex chromosomes aneuploidies. QF-PCR is a diagnostic procedure, but NIPT is a screening method. It is an alternative for confirmatory test following positive test results from NIPT.

AneuSure® Premium Features

• Multiplex analysis of 26 loci in a single reaction
• Use of highly polymorphic STR markers
• Rapid diagnostic follow-up after NIPT testing or first or second trimester screening tests
• Accurate detection of Turner Syndrome
• Optimized to work on wide variety of human DNA sources
• Applicable to a range of DNA inputs – amniotic fluid (AF), chorionic villus (CVS), fetal tissue, etc.
• Can be used by any of Genetek Direct PCR products like GT DBC, GT DBC Blue, as well as direct amplification of Blood, Amniotic Fluid and other cultured cells, Chorionic Villi and other tissues using these lysis buffers (i.e. GT BLB, GT AFLB and GT CVLB)
• Easy to use mix

For research use only. Not for use in diagnostic procedures.

Product Details

The AneuSure® QF-PCR Aneuploidy Diagnostic Kit contains a total of 26 markers, which are distributed across autosomal chromosomes 21, 18 and 13 and sex chromosomes X & Y. The segmental duplication, 7X marker, is included in the kit for the differentiation of X chromosome monosomy from homozygosity (i.e., it quantifies chromosome X for more accurate detection of Turner Syndrome). Primer design for this kit followed the European Molecular Genetics Quality Network guidelines.

QF-PCR is a diagnostic procedure, but NIPT is a screening method. It is a method of choice for confirmatory test following positive test results from NIPT. Please consult the AneuSure® user manual for more detailed information.

AneuSure® performance has been validated with extensive testing using Applied Biosystems TM 3500/xl and 3130/xl platforms. It has been tested for detection and analysis of more than 1000 fetal samples. It is intended to be used with DNA from blood, amniotic fluid cells, CVS, and fetal cells from abortus material.

For research use only. Not for use in diagnostic procedures.

Markers

D21S1809, D21S1446, D21IFNAR, D21S1414, D21S1442, D21S1411, D18S390, D18S391, D18S1002, D18S535, D18-GATA178F11, D13S325, D13S252, D13S634 , D13S258, D13S797, DXS7132, HPRT, DXS6803, 7X, DX-TATC 13.3, DXS981, AMXY, SRY, Y/X b and DYS437 totaling 26 markers.

Chromosome Locations

Table below shows markers in the AneuSure Kit. Names, dye used, size range and chromosome locations are shown.

Sample Profile

Comparison Table

The table shows number of markers for each Genetek QF-PCR kit. There are 26 markers in the AneuSure, 28 in the AneuSure Plus, 32 in the AneuSure Extra, 34 in AneuSure Extra Plus, 32 in AneuSure Max and 34 in AneuSure Max Plus kits. There are 7 segmental duplications in the AneuSure Extra and AneuSure Extra Plus. There are 2 segmental duplication and 5 additional STR markers in AneuSure Max and AneuSure Max Plus kits. The availability of the above-mentioned kits provide medical geneticists with many powerful options to choose from, considering the requirements of each case. Our innovative inclusion of SMA detection power (by addition of SMN1 and SMN2 exon 7 deletion and conversion in AneuSure Plus, AneuSure Extra Plus and AneuSure Max Plus kits) creates a considerable advantage for any laboratory to detect fetuses who may be normal for aneuploidy but affected with a deadly and costly disease like SMA.

Compatibility

This kit is compatible with 5-dye capillary electrophoresis systems like ABI 3130/xl, 3500/xL, and SeqStudio Genetic Analyzers from Thermo Fisher Scientific with either 30, 50, or 80 cm capillaries. ​

This kit can be used on various sources of DNA including DNA extracted from various sources or DNA obtained using any of extraction free (direct) materials from Genetek such as GT AFLB (Amniotic Fluid Lysis Buffer), GT CVLB (Chorionic Villus Lysis Buffer, GT BLB (Blood Lysis Buffer), and filter papers (GT DBC or GT DBC Blue).

Kit Content

The kit contains all the necessary reagents and buffers for multiplex PCR (Multiplex Primer mix, PCR buffer, GT HSTaq DNA Pol in Box A). Also, the kit comes with GT500 size standard as well as GTM5 Matrix Standard for calibrating the Genetic Analyzer (Box B).