Introduction
The document discusses the STAT-NAT® BKV kit, a lyophilized Real-Time PCR mix designed for the detection and quantification of BK Virus (BKV) DNA. BKV is a common virus that remains latent in the urinary tract and can reactivate, particularly in immunocompromised individuals, leading to nephropathy and hemorrhagic cystitis.

Kit Specifications
The STAT-NAT® BKV kit is effective for detecting and quantifying BKV DNA in urine, plasma, and whole blood samples. It offers high sensitivity and specificity, linearity, and quantitation performance. The kit is ready-to-use, can be stored at room temperature, and includes internal controls and calibrators.

Benefits

• Detects and quantifies BKV-specific DNA.
• Compatible with various sample types.
• Improves test sensitivity even with low DNA concentrations.
• Environmentally sustainable with no need for temperature-controlled shipping.
• Contains all necessary reaction components, including Hot Start Polymerase.

Performance
The kit demonstrates a specificity of ≥95% and an analytical sensitivity (Limit of Detection) of 5 copies per reaction. It is validated on CFX96 (Bio-Rad) and QS5 (ABI) platforms.

Graphical Data
The document includes a standard curve graph showing the amplification cycles and the performance metrics such as efficiency (E=114.4%), R²=0.994, and slope=-3.020.

Conclusion
Available since June 2019, the STAT-NAT® BKV kit simplifies molecular biology processes by minimizing analytical variables and ensuring reliable performance across various molecular biology techniques.