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For In Vitro Diagnostic Use

The Abbott RealTime CMV assay is an in vitro polymerase chain reaction (PCR) assay for the quantitation of cytomegalovirus (CMV) DNA in human plasma or whole blood.

The assay is intended for use 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 plasma or whole blood DNA levels.

This assay is not intended to be used as a screening test for CMV or as a diagnostic test to confirm the presence of CMV infection.

Development Philosophy

The Abbott RealTime CMV assay uses PCR technology combined with homogeneous real time fluorescent detection for the quantitation of CMV DNA. The selection of two conserved regions of CMV genome provides for the robust and accurate detection of CMV.

Single Stranded Probe Design

  • In the absence of target sequences, the probes adopt a conformation that brings the quencher close enough to the excited fluorophore to absorb its energy before it can be fluorescently emitted.
  • These are linear probes that fold naturally into a random coil to be in the “off” configuration.
  • When the probe binds to its complementary sequence in the target, the fluorophore and the quencher are held apart, allowing fluorescent emission and detection.
  • Since this is fluorescence occurs during every cycle, the PCR reaction can be read and monitored in real-time.
Abbott RealTime Cmv
Sensitivity31.2 IU/mL (20 copies/mL) plasma sample
62.4 IU/mL (40 copies/mL) whole blood sample
Linear rangePlasma samples: 31.2 IU/mL to 156 million IU/mL
Whole blood samples: 62.4 IU/mL to 156 million IU/mL
Internal ControlNon-competitive pumpkin DNA, added to lysis buffer during extraction
CalibrationExternal two point calibration
Standardization1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162)
Specimen typePlasma (EDTA) and whole blood (EDTA)
Input volume0.5 mL plasma, 0.3 mL whole blood
Sample preparationm2000sp - plasma & whole blood
m24 sp and manual - plasma