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STaR and SuperSTaR Optima QF-PCR

STaR and SuperSTaR Optima QF-PCR

STaR and SuperSTaR Optima QF-PCR

Product catalog summary

Overview: The document describes the ChromoQuant® QF PCR kit, an In Vitro Diagnostic (IVD) kit developed by CyberGene AB for the rapid and accurate diagnosis of chromosomal aneuploidies, including Down syndrome (Trisomy 21), Edward syndrome (Trisomy 18), and Patau syndrome (Trisomy 13). The kit also facilitates the detection of Klinefelter syndrome (XXY), Turner syndrome (X0), and sex determination.

Key Advantages:

  • Superior number of genetic markers for enhanced accuracy.
  • Optimized performance and high flexibility for users.
  • Includes Taq polymerase, ready to use.
  • Detection of maternal contamination to prevent misdiagnosis.
  • Results available within 6 hours, with a total response time of less than 24 hours.
  • Validated for use with all sequencers from Life Technologies/ThermoFisher Scientific.

Kit Specifications:

  • The SuperSTaR Optima kit contains 34 unique genetic markers across two tubes, ensuring 99.9% of samples yield informative results.
  • Available as single tube tests (STaR Optima1) or duplex tests (SuperSTaR Optima) for higher resolution.
  • Complies with best practice guidelines for QF-PCR and is CE-marked for IVD use.
  • Detection format is Capillary Electrophoresis with Genetic Analyser.
  • Validated for use with ABI 310, 3100, 3130, 3730, 3500, and SeqStudio genetic analysers.

Product Variants:

  • SuperSTaR Optima: Available in kit sizes of 26, 68, and 136 tests.
  • STaR Optima 1: Available in kit sizes of 26, 68, and 136 tests, containing 22 markers.
  • STaR Optima 2: Available in kit sizes of 26 tests, containing 13 markers, complements Optima 1.

Company Information: CyberGene AB is a Swedish company specializing in MedTech, developing, manufacturing, and selling IVD products. ChromoQuant® is a registered trademark of CyberGene AB, and the product is manufactured under the ISO 13485 quality system.

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Catalog excerpts

STaR and SuperSTaR Optima QF-PCR-1

ChromoQuant® QF PCR kit STaR and SuperSTaR • Down syndrome Trisomy 21 • Klinefelter syndrome (XXY) • Edward syndrome, Trisomy 18 • Turner syndrome (X0) • Patau syndrome, Trisomy 13 • Sex determination • Superior number of markers • Optimised performance • High flexibility for users • Many X markers in combination with Turner X0 verifying marker • Turner X0 verifying TAF9B marker present in both reaction mixes • Taq polymerase included, ready to use • Detection of maternal contamination eliminates the risk of misdiagnosis • The diagnostic procedure is based upon amniocentesis/CVS. Results are achieved within 6 hours enabling a "time to reply" of less than 24 hours. • The ChromoQuant® kits are validated for all sequencers from Life Technologies/ ThermoFisher Scientific High specificity The SuperSTaR Optima kit holds 34 unique genetic markers in two tubes. This large number of markers means the ChromoQuant® Optima kit will analyse 99,9% of all samples with an informative result. High Flexibility The Optima kits can be used as single tube tests (STaR Optima1) with the availability of extra markers (STaR Optima2) or as a duplex test (SuperSTaR Optima) for higher resolution. GeneMarker and GeneMapper templates for easy interpretation and reporting are available as downloads.

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STaR and SuperSTaR Optima QF-PCR-2

Product specification CyberGene AB Banvaktsvagen 22 SE-171 48 Solna Sweden Sales support: [email protected] Technical support: [email protected] ChromoQuant® has been thoroughly validated. ChromoQuant® was clinically introduced in early 2004 and is used world wide. ChromoQuant® is CE marked in accordance with the IVD Directive 98/79/EC and produced by CyberGene AB under quality system ISO 13485. CyberGene AB is a Swedish company, active in the MedTech field by developing, manufacturing and selling In Vitro diagnostic products. ChromoQuant is a registered trademark of CyberGene AB.

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