Clinical Performance of the Aptima CMV Quant Assay on the Panther System
Study of the Hologic Cytomegalovirus (CMV) Assay
Sponsor: Hologic, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAS4633
Contact: Cristina Falo, PhD: 212-305-3839 / cf2427@cumc.columbia.edu
Additional Study Information: This research study for people who have tested positive for cytomegalovirus (CMV) after receiving a solid-organ transplant or stem cell transplant. This is a non-interventional study. This study involves the use of an investigational test called the Aptima CMV Quantification Diagnostic Assay (Aptima CMV Quant Assay) to determine the levels of CMV in your body. This test has not been approved for sale or use by the US Food and Drug Administration (FDA). Its use is experimental in this study. Hologic, Inc. sponsors this research study. In addition to the standard of care routine CMV monitoring, a study blood sample will be taken by the study team and processed for plasma (pale yellow liquid part of blood). The plasma sample will be tested to determine the levels of CMV in your body. After the testing is completed, the remaining plasma sample and information collected with the samples may be stored for future research with your permission. This study will use your CMV plasma sample.
This study is closed
Investigator
Marcus Pereira, MD, MPH
Do You Qualify?
Are you 18 years of age or older? Yes No
Have you tested positive for cytomegalovirus (CMV) after receiving a solid-organ transplant or stem cell transplant? Yes No
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You may be eligible for this study

Place Holder




For more information, please contact:
Cristina Falo, PhD
cf2427@cumc.columbia.edu
212-305-3839