INTENDED USE
 

The Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate cytomegalovirus (CMV) DNA in human EDTA plasma. The Alinity m CMV assay is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant and Solid Organ Transplant patients who are undergoing anti-cytomegalovirus therapy. The Alinity m CMV assay can be used to assess virological response to anti-cytomegalovirus therapy. The results from the Alinity m CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The Alinity m CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products.
 

LIMITATIONS OF THE PROCEDURE

• Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert).
• Human plasma (K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m CMV assay. The use of other plasma tubes has not been evaluated.
• Debris within plasma specimens (eg, fibrin strands) may interfere with sample processing.
• Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
• The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
• Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with clinical signs and symptoms and other relevant laboratory results.
• A specimen with a result of “Not Detected” cannot be presumed to be negative for CMV DNA.
• Due to the potential for variability in CMV viral load measurements across different CMV assays, it is recommended that the same device be used for the quantitation of CMV viral load when managing CMV infection in individual patients.
• Testing of drug resistant CMV specimens has not been evaluated in the clinical study.
• Test performance characteristics have been evaluated only for individuals who have undergone solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT), and have been diagnosed with CMV disease and are undergoing treatment. No information is available on test performance in patients undergoing other types of transplant procedures, neonates or pediatric patients, or AIDS or other immunocompromised patients.
• This test is intended for use as an aid in the management of solid-organ transplant and HSCT patients who have been diagnosed with CMV disease and are undergoing antiviral therapy. In this population, the test can be used to assess virological response to treatment by measuring the baseline CMV DNA level and to assess the effects of antiviral therapy by measuring CMV DNA during the course of antiviral treatment. Patient management decisions should not be made based solely on the results from this test. Other laboratory and clinical factors must also be considered in making clinical decisions.
• Clinicians should take individual patient risk factors as well as current clinical guidelines into account when using CMV viral load results for the management of transplant patients.
• This test is not intended for use as a screening test for the presence of CMV in blood or blood products and has not been evaluated as a diagnostic test to confirm the presence of CMV infection.