Recipient CMV Serostatus

*The timeline requirements for this form are as follows:
Assessment Time Frame: Screening occurs up to 45 days prior to the anticipated start of the conditioning regimen. May be performed earlier than 45 days prior to the start of the conditioning regimen.
Submission Time Frame: Within 5 business days of collection.

Date CMV tested:
Enter the date CMV was tested. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.

Per protocol an infectious disease assessment is required at Screening. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

If the date entered is a future date, a query will appear in the EDC.

CMV serostatus:
Report the cytomegalovirus (CMV) status of the subject at screening as Positive, Negative, or Inconclusive. Report the result of CMV IgG antibody or total IgG/IgM. Do NOT report CMV IgM antibody. Per protocol an infectious disease assessment is required at Screening. If this field is marked as “Intentionally Left Blank” a protocol deviation should be logged in the EDC.

Cytomegalovirus (CMV) is a common virus that infects 50-80% of adults worldwide and is transmitted from person to person through bodily fluids. The virus that causes CMV is part of the herpes virus family and, like other herpes viruses, CMV may be dormant for a period of time before the virus is activated in the host. CMV infections are usually harmless in a healthy immune system and typically cause only mild symptoms, if any. However, if a person’s immune system is seriously weakened (as in an immunosuppressed stem cell recipient) the virus can have serious consequences such as pneumonia, liver failure, and even death.

Most laboratory reports indicate a positive result as reactive, and a negative result as non-reactive. Occasionally, laboratory reports show a specific antibody titer. In this case, compare the laboratory result to the reported standards to determine if the result was reactive (positive) or non-reactive (negative).

If the laboratory reports the results as “indeterminate” or “equivocal,” select Inconclusive.

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