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Description
Human Cytomegalovirus Quantitation Real Time PCR Kit is an in vitro polymerase chain reaction (PCR) assay for use with multiplex real-time fluorescence analyzer to detect and quantitate cytomegalovirus (CMV) DNA in human urine and serum.
This assay is designed to assist in diagnosing and managing CMV with signs and symptoms of CMV infection, such as CMV congenital infection, CMV hepatitis, CMV pneumonia, mononucleosis-like syndrome, and immunosuppressed symptomatic infection, transplant patients and other immunocompromised patients. The intended use of the assay is in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in CMV DNA levels. This assay is not intended for use in screening blood, plasma, blood products, tissue, or organ donors for CMV.
Features
- LOD: 100 IU/mL
- Internal control monitors the DNA extraction and PCR amplification efficiency of specimens
- 4 HCMV Quantitative Reference Standards
-
Specimen type: Urine or Serum
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
Certificates
NMPA, CE-IVDR
Specification
| Limited of Detection | 100 IU/mL |
| Sample Input Volume | 20 ul |
| Storage | -20°C±5°C |
| Shelf Life | 12 months |
| MD109201E00201-24T | Human Cytomegalovirus Quantitation Real Time PCR Kit | 24 tests/kit |
| MD109201E00201-48T | Human Cytomegalovirus Quantitation Real Time PCR Kit | 48 tests/kit |
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