Abbott RealTime CMV

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 EDTA plasma. 

icon-pdf.pngAbbott RealTime CMV Package Insert (PDF – 1.0 MB) For Information Only - Not a Controlled Copy

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Description
 

CMV is a common virus that remains dormant in healthy individuals. In immunocompromised patients, CMV can lead to serious complications. Precise and timely quantitation of CMV in critically ill patients is important to:

  • Guide preemptive strategies for disease prevention
  • Diagnose onset of condition
  • Monitor response to therapy
  • Detect reactivation of latent virus

RealTime CMV is designed to deliver highly precise and timely results to help inform better patient management.

Indications and Limitations of Use

Intended Use:

The Abbott RealTime CMV test is an in vitro polymerase chain reaction (PCR) assay for the quantitation of cytomegalovirus (CMV) DNA in human (EDTA) plasma. The Abbott RealTime CMV test is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant patients who are undergoing anti-cytomegalovirus therapy. In this population, serial DNA measurement can be used to assess virological response to anti-cytomegalovirus therapy. The results from the RealTime CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The RealTime CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products. 

Limitations of the procedure:

FOR IN VITRO DIAGNOSTIC USE ONLY

-  Test performance characteristics have been evaluated only for individuals who have undergone Hematopoietic Stem Cell Transplant. No information is available on test performance in patients undergoing other types of transplant procedures, neonates or pediatric patients, AIDS or other immunocompromised patients; nor is information available on test performance in patients who have been diagnosed with end organ CMV disease.

-  The detection of viral DNA is dependent upon proper specimen collection, handling, transportation, storage, preparation (including extraction). Failure to observe proper procedures in any of these steps can lead to incorrect results. There is a risk of false negative results resulting from improperly collected, transported, or handled specimens.

-  Though rare, mutations within the highly-conserved regions of the viral genome covered by the primers and/or probes in the Abbott RealTime CMV assay may results in the under-quantitation of virus or failure to detect the presence of virus. The Abbott RealTime CMV assay mitigates this risk by amplifying two select targets of conserved regions of the CMV genomes.

-  Human plasma (EDTA) may be used with the Abbott RealTime CMV assay. The use of other anticoagulants has not been validated for use with the Abbott RealTime CMV assay.

-  A specimen with a result of “Not Detected” cannot be presumed to be negative for CMV DNA.

-  Drug interference was evaluated using drug pools, and effects of individual drugs were not assessed, with the exception of the 13 therapeutic drugs that were tested individually.

-  Results from the Abbott RealTime CMV assay should be interpreted in conjunction with other clinical and laboratory findings.

Caution: Rx only

Design
 

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.

Abbott RealTime CMV probe design

  • 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 probe design

Specifications
 
 
 
Abbott RealTime Cmv
Instrumentation Extraction: m2000sp
Amplification & Detection: m2000rt
Technology Quantitative real-time PCR
Probe Design Single-stranded linear probe
Target Region UL34 and UL80.5 genes
Limit of Detection (LOD) 31.2 IU.mL
Lower Limit of Quantitation (LLOQ) 50 IU/mL
Quantitation Range From LOQ up to 8.19 log IU.mL
Specificity ≥ 100%
Precision SD < 0.15 IU/mL 
Reported Results IU/mL, log IU/mL
Standardization 1st WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162)
Sample Types Plasma
Sample Input Volume 0.5 mL
Internal Control Noncompetitive processed with each sample

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