Human Cytomegalovirus Real Time PCR Kit

The Human Cytomegalovirus Real Time PCR Kit is an in vitro assay designed to detect and quantify CMV DNA in human urine and serum on compatible multiplex real-time fluorescence analyzers. Its workflow incorporates an internal control to monitor DNA extraction and amplification, alongside four quantitative reference standards.

This assay assists qualified professionals in diagnosing and managing CMV-associated conditions—including congenital infection, hepatitis, pneumonia, and mononucleosis-like syndrome—particularly in transplant recipients and immunocompromised patients. It also monitors response to antiviral therapy through changes in viral load, though it is not intended for screening blood, tissue, or organ donors.

• LOD: 100 IU/mL
• Specimen type: Urine or Serum
• Quantitative CMV DNA testing: Detects and quantifies CMV DNA
• Internal workflow control: Monitors DNA extraction and PCR amplification efficiency.
• 4 HCMV quantitative reference standards: Supports CMV viral load measurement within the assay workflow.

Validated PCR Instruments:

•  ABI 7500 Real Time PCR System
•  QuantStudio™ 5 Real Time PCR System
• Bioperfectus STC-96A/96A PLUS Real Time PCR System
• Roche's LightCycler 480 PCR System

This CMV real-time PCR kit is intended for professional urine and serum testing. Applications include:

• CMV diagnostic support: Quantitative CMV DNA testing as an aid in evaluating patients with signs and symptoms of CMV infection.
• Patient management support: Use together with clinical presentation and other laboratory markers in the management of CMV-related conditions described in the intended use.
• Antiviral response monitoring: Measurement of changes in CMV DNA levels as an aid in monitoring viral response to antiviral treatment.

NMPA, CE-IVDR