https://www.prnewswire.com/news-releases/fda-in-brief-fda-updates-emergency-use-authorization-for-covid-19-convalescent-plasma-to-reflect-new-data-301222805.html

Quote:

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Today, the FDA is revising the Letter of Authorization for COVID-19 convalescent plasma to limit the authorization to the use of high titer COVID-19 convalescent plasma only for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. Plasma with low levels of antibodies has not been shown to be helpful in COVID-19.

The use of low titer COVID-19 convalescent plasma is no longer authorized under the EUA as additional data from clinical trials, including randomized, controlled trials, have not shown evidence to demonstrate that low titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19.

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And my Friday work plans went all to heck...

We have been meeting all morning on this change and how to adapt overnight.

More to come... but this is s big change in our distribution and collection strategies.

I have a 2:15 Appt today to give convalescent plasma again.

Does this mean Covid antibodies via convalescent plasma aren't needed / used anymore?

Gilligan said:

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I have a 2:15 Appt today to give convalescent plasma again.

Does this mean Covid antibodies via convalescent plasma aren't needed / used anymore?

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No. Not necessarily. Please keep you appointment today.

Basically it means that we can only distribute CCP that has a high titer or value of 9.5 or greater. 30% ish of donors we have seen have a high titer. You may be one of those. It is still of great value and hospitals are still ordering.

Going forward, if you have a low titer, they will probably ask you to donate whole blood unless your titer levels remain the same.

This also only effects centers that are operating under the EUA. Some centers are still operating under the IND program which expires at the end of may. They are not Titering their plasma yet.

SoulSlaveAG2005 said:

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Gilligan said:

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I have a 2:15 Appt today to give convalescent plasma again.

Does this mean Covid antibodies via convalescent plasma aren't needed / used anymore?

---

No. Not necessarily. Please keep you appointment today.

Basically it means that we can only distribute CCP that has a high titer or value of 9.5 or greater. 30% ish of donors we have seen have a high titer. You may be one of those. It is still of great value and hospitals are still ordering.

Going forward, if you have a low titer, they will probably ask you to donate whole blood unless your titer levels remain the same.

This also only effects centers that are operating under the EUA. Some centers are still operating under the IND program which expires at the end of may. They are not Titering their plasma yet.

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Thanks, I will keep my appt.. There is limited information on the GCRBC Donor Portal.

It just says Covid Antibody Test - Positive. Nothing else.

I tested negative for Covid Jan 4th PCR and Jan 6th Rapid.

Is there a way to know what my levels are? Just out of curiosity.

Plasma is always good to give, I know a lot of people have made it a point to keep giving blood and plasma as a way to give back to the community

Gilligan said:

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SoulSlaveAG2005 said:

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Gilligan said:

---

I have a 2:15 Appt today to give convalescent plasma again.

Does this mean Covid antibodies via convalescent plasma aren't needed / used anymore?

---

No. Not necessarily. Please keep you appointment today.

Basically it means that we can only distribute CCP that has a high titer or value of 9.5 or greater. 30% ish of donors we have seen have a high titer. You may be one of those. It is still of great value and hospitals are still ordering.

Going forward, if you have a low titer, they will probably ask you to donate whole blood unless your titer levels remain the same.

This also only effects centers that are operating under the EUA. Some centers are still operating under the IND program which expires at the end of may. They are not Titering their plasma yet.

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Thanks, I will keep my appt.. There is limited information on the GCRBC Donor Portal.

It just says Covid Antibody Test - Positive. Nothing else.

I tested negative for Covid Jan 4th PCR and Jan 6th Rapid.

Is there a way to know what my levels are? Just out of curiosity.

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I'm not real sure on what Gulf coasts policies/procedures are. I am with Carter in the dfw area and we only release the same information of Pos/Neg from donors. Mainly because the software we use is already set for that type of value. Changing it would cost $$ that is probably only a temporary phenomenon of posting titer values, and our cost/benefit analysis isn't there for an expensive software change.

P.U.T.U said:

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Plasma is always good to give, I know a lot of people have made it a point to keep giving blood and plasma as a way to give back to the community

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Absolutely. We will always take a will donor. However depending on blood type just donating plasma can actually have a negative effect on a community blood center. In some instances/types, there can be an abundance of plasma for transfusion services and then the plasma outdates and is wasted. The collection kits can sometimes cost more than we can be reimbursed for the plasma. Therefore we ask certain blood types to just donate red cells and/or platelets to help ensure we collect what patients need and won't be outdated.