CE Marked
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.
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CE Marked
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
| Abbott RealTime Cmv | |
| Sensitivity | 31.2 IU/mL (20 copies/mL) plasma sample 62.4 IU/mL (40 copies/mL) whole blood sample |
| Linear range | Plasma samples: 31.2 IU/mL to 156 million IU/mL Whole blood samples: 62.4 IU/mL to 156 million IU/mL |
| Internal Control | Non-competitive pumpkin DNA, added to lysis buffer during extraction |
| Calibration | External two point calibration |
| Standardization | 1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162) |
| Specimen type | Plasma (EDTA) and whole blood (EDTA) |
| Input volume | 0.5 mL plasma, 0.3 mL whole blood |
| Sample preparation | m2000sp - plasma & whole blood m24 sp and manual - plasma |
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.
