CMV

Ebbie

I noticed that on some of your donors it says their CMV status is positive, but then in parenthesis, it says certain portions are negative. What does this mean? Overall they are still positive?

cryo-admin

Hi Ebbie -

This means a donor tested CMV total antibody positive, but confimatory tests establish that he is actually CMV negative. Total antibody is the screening test mandated by the FDA. It is not a particularly accurate test as it returns about 30% false positive results.

When a donor comes back total antibody positive, we do a set of more precise tests to determine whether he has actually been exposed to CMV. These are the igG and igM tests. In some cases, a total antibody positive donor will be negative for both igG and igM, meaning the total antibody test was wrong.

FDA guidelines require us to report the donor as CMV positive, even though we do not believe he has ever been exposed to the virus.

If your doctor instructed you to select a CMV negative donor, consult with him prior to purchasing this donor.

If you are CMV positive - and more than half the adult population is without ever knowing it - CMV status is irrelevant to you.

Best of luck,

Scott
CCB

Ebbie

I am CMV negative and was advised to choose a CMV negative donor. To clarify, if the total antibody screening was considered wrong, why isn't it just done again to potentially avoid the false positive?

cryo-admin

Hi Ebbie –

We may actually do several CMV total antibody screenings on a donor. If just one of them returns a false positive, even when the additional antibody screenings return as negative and all of the confirmatory tests establish that the donor is CMV negative, the FDA guidelines require us to report the donor as CMV positive.

On our website, we list the donor as CMV positive because of the FDA guidelines, but we include that his igG and igM tests are negative. We include the negative results because after our medical director’s review of the testing, it would be inaccurate to infer that the donor was exposed to the virus.

We include test results on the Summary of Records that gets sent to your physician with your specimen. As always, we encourage you to speak to your physician about any medical concerns you may have. Please feel free to have your physician contact us if he/she has any questions.

Regards,

Nicole
CCB