Indications and Limitations of Us

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 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 genome.

-  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.

WARNINGS AND PRECAUTIONS

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

Due to inherent differences among technologies, it is recommended to assess the impact of any potential change in the method for quantification of CMV DNA during the clinical management of a patient.

Rx Only

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