PCG® AZF Multiplex PCR Kit

PCG® AZF Multiplex PCR Kit

Principle: Multiplex PCR

Intended use: PCG® AZF Multiplex PCR Kit is an in vitro nucleic acid amplification test kit to detect microdeletions in the AZFa, AZFb, AZFc regions of the AZF gene (AZF - Azoospermia Factor is a gene located on the long arm of the Y chromosome at position Yq11. This is a region containing many genes related to spermatogenesis).

Overview

PCG® AZF Multiplex PCR Kit is recommended to be used to detect deletions through STS markers (Sequence - Tagged Sites) in the AZFa, AZFb and AZFc regions of the Y chromosome in the following cases:

Sperm density is less than 5 million per mL

Non‐obstructive azoospermia

Before undergoing varicocele surgery

The family history includes a brother with AZF deletions

Specification

Regulatory Status	RUO
Intended Use	Detect deletions through STS markers in the AZFa, AZFb and AZFc regions of the Y chromosome
Type of Analysis	Quantitative
Validated Specimen	Whole blood
Technology	Multiplex PCR and Capillary electrophoresis
Detection Channels	FAM: AMEL, sY14, sY153, sY127, sY1192, sY86, sY254, sY1065, sY83, sY1191 HEX: sY255, sY160, sY134, sY84, sY88, sY121, sY82, sY105, sY1291
Instruments	Thermocycler Module system OT-2, Applied Biosystems ProFlex, Capillary Electrophoresis Instruments
Performance Characteristics	- Clinical sensitivity: 100% - Clinical specificity: 100% - Repeatability: >99% - Reproducibility: >99%