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Simple and robust extended chromosomal aneuploidy analysis with QF-PCR technology
Expertly balances clinical utility and ease of use
Compatible with a range of capabilities and instrumentation

Focus on clinical utility

Miscarriage is defined as the spontaneous loss of pregnancy before the foetus reaches viability, and includes all pregnancy losses from the time of conception until 24 weeks of gestation. Recurrent miscarriage is the loss of three or more consecutive pregnancies, and affects nearly 1% of couples trying to conceive.

50% of first trimester recurrent miscarriage cases have been shown to be caused by a chromosome abnormality. The most commonly noted abnormality group is the trisomies, which account for 60% of all chromosomal disorders observed in products of conception (POC). Within this group, the most frequently observed trisomy is chromosome 16. Trisomy of chromosomes 13, 15, 18, 21 and 22 are also commonly seen. Other aneuploidies commonly seen include monosomy X, and triploidy. These account for approximately 20% and 15% of all abnormalities respectively.

Rapid aneuploidy analysis in recurrent miscarriage

Traditionally, POC samples were analysed using standard cytogenetic techniques. These techniques, involving tissue culture and microscopic analysis, can take up to 14 days to provide a diagnosis. In particular, fluorescent in situ Hybridisation (FISH) using interphase cells is expensive, time consuming and unsuitable for high throughput use. QST*R-PL takes advantage of the QF-PCR (Quantitative Fluorescence-Polymerase Chain Reaction) technique. Using PCR amplification, fluorescent dye labelled primers target highly polymorphic regions of DNA sequence, short tandem repeats (STRs), located on the chromosomes of interest.

Each targeted STR marker is specific to the chromosome on which it is located, thus the copy number of the STR marker can be diagnostic of the copy number of the chromosome. In an individual unaffected by a trisomy, two alleles of a chromosome specific STR are determined by the QF-PCR technique as two peaks in a 1:1 ratio. The observation of an extra STR allele as either a three peak pattern in a 1:1:1 ratio or two peak pattern in a 2:1 or 1:2 peak ratio is diagnostic of the presence of an additional sequence, which in turn may represent an additional chromosome as in the case of a trisomy.

Individual results can be obtained within a few hours of receipt of samples. In routine use, turnaround reporting times of less than 24 hours from sample receipt are easily achievable. QF-PCR does not require cell culture, resulting in reduced failure rates and cost savings.

The QST*R-PL Kit is for the routine in vitro quantitative diagnosis of the six most common autosomal trisomies associated with pregnancy loss: trisomy 13 (Patau's syndrome), trisomy 15, trisomy 16, trisomy 18 (Edwards' syndrome), trisomy 21 (Down's syndrome) and trisomy 22. The kit also includes X and Y chromosome markers, as well as the TAF9L marker for the assessment of sex chromosome complement. The results obtained from QST*R-PL Kit will determine the aneuploidy status of the foetus, and may be useful in ongoing reproductive planning counselling and decision making.

Flexibility and simplicity from sample to report

The QST*R-PL kit is compatible with most commonly employed DNA extraction protocols, thermal cyclers and capillary electrophoresis instruments. This flexibility in approach is complemented by simple and easy to use analysis software for reporting. Results can be analysed through either Life Technologies GeneMapper or SoftGenetics GeneMarker software. GeneMarker’s operation now includes a customised Trisomy Analysis function. By selecting BPG (Best Practice Guidelines) settings within the Trisomy Analysis function users can quickly and accurately measure allele ratios to obtain a full patient sample report within minutes. 

Ordering Information

Kit NameDescriptionPlatformCatalogue Code

Elucigene QST*R-PL Pregnancy Loss Kit

Detects trisomies of chromosome 13, 15, 16, 18, 21, 22, X and Y.

Genetic Analyser

AN6XYB1

Elucigene kits are developed and manufactured within quality systems accredited to ISO9001:2008 and ISO13485:2003 and are validated as in vitro diagnostic devices in compliance with the European Community Directive 98/79/EC and the Canadian Medical Device Regulations (CMDR). Elucigene is a trademark of Delta Diagnostics (UK) Ltd. ARMS is a trademark of AstraZeneca UK Ltd. GeneMarker® is a trademark of SoftGenetics Corporation. GeneMapper™ is a trademark Thermo Fisher Scientific. VIC, PET and NED are trademarks of Life Technologies Corporation.

Licensee Kits: This product is sold pursuant to an agreement with Life Technologies Corporation. The purchase of this product conveys to the buyer the non-transferable right to use only the purchased amount of the product and its components only for human in vitro diagnostics, solely for the clinical indication described in the accompanying instructions for use. For information on obtaining rights to use this product or its components, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

FAQs

  • What is the test for? +

    For the routine in vitro quantitative diagnosis of the six most common autosomal trisomies associated with pregnancy loss: trisomy 13 (Patau's syndrome), trisomy 15, trisomy 16, trisomy 18 (Edwards' syndrome), trisomy 21 (Down's syndrome) and trisomy 22. The kit also includes X and Y chromosome markers and the TAF9L marker for the determination of sex chromosome aneuploidies.
  • What specific chromosomes are analyzed? +

    QST*R-PL detects aneuploidy of autosomal chromosomes 13, 15, 16, 18, 21, 22 using 4 heterozygous short tandem repeat (STR) markers per chromosome. The assay also contains X and Y specific non-STR markers for sex determination of sex chromosome aneuploidy.
  • Why these chromosomes? +

    These autosomal chromosomes are associated with the six most common autosomal trisomies associated with first trimester pregnancy loss: trisomy 13 (Patau's syndrome), trisomy 15, trisomy 16, trisomy 18 (Edwards' syndrome), trisomy 21 (Down's syndrome) and trisomy 22.
  • When can it be used? +

    QST*R-PL is designed to be used on DNA extracted from the products of conception and fetally derived tissue. The results obtained from QST*R-PL kit will help determine the aneuploidy status of the fetus and may be useful in the management of the consequences resulting from the spontaneous miscarriage and for modification of risk calculations for future pregnancies.
  • What equipment is required? +

    The QST*R-PL assay is a QF-PCR based assay. Accordingly, it will require an amplicon-free environment for assay set up. The PCR is performed on a thermal cycler (equivalency testing has been performed on a limited range of thermal cyclers to assess and evaluate the robustness of the Elucigene QST*R-PL assay). Fragment analysis will require the use of an ABI Genetic Analyzer 3130/3500 instrument.
  • How long does the test take? +

    The assay has been developed as a single tube reaction. Accordingly, hands on time during assay set up is kept to a minimum. Assay set up time for 16 samples (1 injection on a 3130xl/3500xl Genetic Analyzer) takes approximately 20 mins. The PCR stage of the assay takes approximately 2 hrs 45 mins to complete, depending on platform in use. For a single injection (16 samples) sample preparation and injection on the 3130xl Genetic Analyzer takes approximately 60 mins from start to finish.
  • How is the analysis carried out? +

    Data analysis for QST*R-PL is carried out using either GeneMapper (Life Technologies) or GeneMarker (SoftGenetics) analysis software packages. Like all QST*R products, QST*RPLhas been developed with both platforms in mind. We provide the necessary analysis files for both software packages, therefore allowing QST*R-PL analysis to integrate seamlessly with existing QST*R analysis.
  • How well does it work? +

    From product concept through to IVD release, QST*R-PL has undergone extensive development and rigorous testing resulting in an extremely robust assay. Consequently you can have complete confidence with the analysis findings.
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