CYTOMEGALOVIRUS

Abbott RealTime CMV

For more information, contact Abbott.

PRODUCT NAME UNIT SIZE ORDER NUMBER GTIN


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.

To learn more about Abbott RealTime CMV please visit: https://www.molecular.abbott/int/en/products/infectious-disease/realtime-cmv

ABBOTT REALTIME CMV
Limit of Detection31.2 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