The Human Cytomegalovirus Quantitative Real-Time PCR Kit is an in vitro test based on the polymerase chain reaction (PCR), used in multiplex real-time fluorescence analyzers to detect and quantify cytomegalovirus (CMV) DNA in human urine and serum samples.
This assay was developed to assist in the diagnosis and management of CMV in patients with signs and symptoms of infection, such as congenital CMV infection, CMV hepatitis, CMV pneumonia, mononucleosis-like syndrome, and symptomatic infections in immunosuppressed individuals, including transplant and other immunocompromised patients.
The test should be used in conjunction with clinical assessment and other laboratory markers, serving as an indicator for initiating therapy and as an aid in monitoring viral response to antiviral treatment, measured by changes in CMV DNA levels.
This assay is not intended for use in the screening of blood, plasma, blood products, tissues, or organ donors.
LOD (Limit of Detection): 100 IU/mL
Internal Control: Monitors the efficiency of DNA extraction and PCR amplification
ABI 7500 Real Time PCR System
QuantStudio™ 5 Real Time PCR System
Bioperfectus STC-96A / 96A PLUS Real Time PCR System
LightCycler 480 PCR System (Roche)
Standards: 4 HCMV quantitative reference standards
Sample Types: Urine or Serum
Packaging: Available in smaller packages: 24 tests/kit and 48 tests/kit
Detection limit: 100 IU/mL
Sample Input Volume: 20 μL
Storage: -20°C ± 5°C
Shelf life: 12 months
NMPA, CE-IVDR
