The Y6 Y Chromosome Microdeletion Detection Kit is a real-time fluorescence PCR (real-time PCR) assay for the quantitative detection of Y chromosome microdeletions in the azoospermia factor (AZF) region from peripheral blood DNA. Designed per the European Academy of Andrology (EAA) and European Molecular Genetics Quality Network (EMQN) best practice guidelines, the kit simultaneously screens six sequence-tagged sites (STSs) across all three AZF subregions in a single run, providing a complete molecular diagnosis for male infertility workup.
WHAT IS Y CHROMOSOME MICRODELETION?
Y chromosome microdeletions are the second most frequent genetic cause of spermatogenic failure in infertile men, after Klinefelter syndrome. These deletions arise from intrachromosomal recombination between large homologous repetitive sequence blocks and cluster in three regions of the long arm of the Y chromosome (Yq), known as the AZF loci:
• AZFa (~13.1-15.2 Mb from the p-telomere)
• AZFb (~18.5-22.8 Mb)
• AZFc (~23.3-25.5 Mb)
Approximately 80% of Y-chromosome microdeletions occur in AZFc, with the remainder distributed across AZFa (0.5-4%), AZFb (1-5%), and AZFbc (1-3%). Molecular diagnosis of AZF microdeletions is now standard in the workup of men with azoospermia or severe oligozoospermia, and is critical for selecting patients most likely to benefit from testicular sperm extraction (TESE) and intracytoplasmic sperm injection (ICSI).
WHY THIS KIT?
Testing the AZF region before assisted reproduction delivers clear, actionable clinical value:
• Prognosis of sperm retrieval: complete AZFa deletion invariably causes Sertoli cell-only syndrome (SCOS) with no retrievable spermatozoa, making TESE futile
• Avoidance of unnecessary TESE/ICSI: complete AZFb and AZFbc deletions similarly predict SCOS or spermatogenic arrest with no TESE success
• Informed family planning: AZFc deletions may be transmitted to male offspring naturally or via ICSI, with variable expressivity
• Personalized treatment pathways: AZFc deletions carry an approximately 50% chance of successful TESE in men with azoospermia, supporting realistic patient expectations
• Compliance with EAA/EMQN best practice guidelines for molecular diagnosis of Y-chromosomal microdeletions
KEY FEATURES
• Comprehensive AZF coverage in a single run: 6 STSs across all three subregions — AZFa (sY84, sY86), AZFb (sY127, sY134), AZFc (sY254, sY255, both in the DAZ gene)
• Two-tube multiplex real-time PCR with four-color detection (FAM, VIC, ROX, Cy5) for clean signal discrimination
• Built-in internal controls: SRY and ZFX/ZFY monitor DNA quality, sample adequacy, and PCR integrity
• High sensitivity: limit of detection ≤1,000 copies/test
• Excellent precision: coefficient of variation (CV) ≤5%
• CE marked, for professional in vitro diagnostic use
SPECIFICATIONS
• Specimen type: peripheral blood collected in EDTA or ACD anticoagulation tubes (heparin is not acceptable)
• Methodology: two-tube multiplex real-time fluorescent PCR (PCR Mix A and PCR Mix B)
• Packaging: 20 tests/kit
• Compatible instruments: Roche LightCycler® 480, Applied Biosystems ABI 7500, Hongshi SLAN®-96S, and Hongshi SLAN®-48P Real-Time PCR systems
• Storage: ≤ -20°C, protected from light; shelf life 9 months (or 2-8°C and use within 7 days after opening); maximum 5 freeze-thaw cycles
• Detection channels: FAM, VIC, ROX, and Cy5
TARGET USERS
Clinical laboratories, hospital andrology and reproductive medicine departments, IVF/ART centers, and molecular diagnostic laboratories performing male infertility workups and pre-ICSI genetic counseling.
Note: For in vitro diagnostic use only. Results are for clinical reference and should be interpreted by a qualified clinician together with karyotype analysis, hormone profile, and other clinical findings.
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