Donor, Cytomegalovirus Total with Reflex Non‑donor CMV, IgM

Casandra

Casandra Test Code QD00846Version 1 (DRAFT)

Performing Lab

Lab Quest DiagnosticsLab Test ID 19618

Donor, Cytomegalovirus Total with Reflex Non‑donor CMV, IgM

Also known as: Donor, CMV Ab, Total wRfl to IgM, DONOR TESTING ONLY

Clinical Use

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Use

This donor screening test evaluates total antibody to cytomegalovirus (CMV) — both IgG and IgM — to assess prior exposure or current infection in potential donors of blood or human cells, tissues, and cellular and tissue‑based products (HCT/Ps). Reactive results may require reflex IgM testing on non‑donor (i.e., recipient or patient) specimens to help evaluate recent infection or seroconversion, aiding in risk reduction of CMV transmission in transplantation or donation contexts.

Special Instructions

This test is intended for donor screening, subject to FDA requirements mandating use of FDA‑approved or cleared assays for relevant communicable disease agent donor testing. Reflex testing for CMV IgM is performed on non‑donor specimens when indicated. Specimens are processed at Quest’s dedicated FDA‑registered Chantilly, VA facility for donor testing.

Limitations

Donor screening tests detect total anti‑CMV antibodies and may not distinguish active from past infection; a reactive result does not necessarily indicate clinical disease or donor ineligibility. Reflex IgM testing aids in determining recent infection, but serologic interpretation may be limited by transient IgM persistence or anamnestic responses. Laboratory‑developed or modified assays are prohibited for donor testing; only FDA‑approved/cleared methods are permitted.

Test Details