CE-Marked In Vitro Diagnostic Medical Device—Y Chromosome AZF Analysis

The Y Chromosome AZF Analysis System complies with EU Directive 98/79/EC on in vitro diagnostic medical devices. The Y Chromosome AZF Analysis System provides a multiplex PCR-based method to analyze the integrity of the human Y chromosome AZF region. The Y Chromosome AZF Analysis System is to be used as part of a diagnostic workup to characterize male infertility. This information is potentially useful for patients considering in vitro fertilization because deletions in the AZF region of the Y chromosome are passed on to male offspring produced by in vitro fertilization, resulting in infertility.

The Y Chromosome AZ...

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The Y Chromosome AZF Analysis System complies with EU Directive 98/79/EC on in vitro diagnostic medical devices. The Y Chromosome AZF Analysis System provides a multiplex PCR-based method to analyze the integrity of the human Y chromosome AZF region. The Y Chromosome AZF Analysis System is to be used as part of a diagnostic workup to characterize male infertility. This information is potentially useful for patients considering in vitro fertilization because deletions in the AZF region of the Y chromosome are passed on to male offspring produced by in vitro fertilization, resulting in infertility.

The Y Chromosome AZF Analysis System consists of 20 primer pairs that are homologous to previously identified and mapped sequence-tagged sites (STS). These primers will amplify nonpolymorphic short DNA segments from the AZF region of the Y chromosome, covering AZFa, AZFb, AZFc, proximal AZFc/AZFd (including DAZ, KALY and SMCY) and flanking loci for other key spermatogenesis-related genes (RBM1, DFFRY and DBY). The Y Chromosome AZF Analysis System is fully compliant with European Molecular Genetics Quality Network (EMQN) recommendations.

The primers have been combined into five Multiplex Master Mix sets (A–E) for use in multiplex PCR. This makes it possible to analyze all 20 STS by performing five concurrent PCR amplifications.

Features - Benefits

• Compliant with EU Directive 98/79/EC: Y Chromosome AZF Analysis System is labeled as an in vitro diagnostic medical device and bears the CE Mark.
• State-of-the-Art Detection of First Choice STS: Primer pairs are compliant with current EMQN recommendations and include primer pairs to amplify SRY.
• Single Amplification: Saves time and labor with simultaneous amplification of 5 multiplex reactions, which analyzes the extent of Y chromosome integrity.
• Complete System: Optimized premixed Multiplex Master Mixes, including control primers to test for PCR amplification, provide a standardized panel of results.

Notes

This product is compliant with EU Directive 98/79/EC on in vitro diagnostic medical devices. This product is only available in certain European countries. Please contact your local Promega representative for availability.

References

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6. Kent-First, M.G. et al. (1999) Mol. Reprod. and Dev. 53, 27–41.
7. Vogt, P.H. et al. (1997) Cytogenet. Cell Genet. 79, 1–20.
8. Skaletsky, H. et al. (2003) Nature 423, 825–37.

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