Parvo and IgG replacement

[Guest guest]

from Dale, Mom to Katy, grown and married

I try to be a resource for you guys and want to make sure that what I

share is helpful and correct. This is some information that I have

gathered regarding the statement that Parvo (Fifth's Disease) can be

transmitted through IgG replacement. I talked with a gentleman in the

industry. He asked that I not use his name or product because in order

to quote him directly, he would have to request a written statement from

his legal department and that could take weeks to get approval. He

felt, and I agreed, that this information was important to this group

and wanted to get it out immediately. So, I am summarizing what we

talked about.

Here's why the statement that Parvo can be transmitted in IgG is very

serious. Think about it. If a known virus can get through the process

- then that opens the door for all unknown viruses to get through. And

that's a scary proposition.

Here's a list of all the previously unknown viruses that have been

recently discovered: HIV, Hepatitis C, Hepatitus B, SARS, West Nile,

Monkey Pox and Avian flu. All of those were totally unknown viruses

until very recently. We have to know that our products are as viral

safe as possible - in fact, we want them more than safe. But there are

no 100% guarantees. That's why on every vial of IgG product --

regardless of the brand. The legal department requires the following

statement: No plasma product is 100% guaranteed safe.

That said: Let's look at exactly what the process is that takes out

viruses in IgG products.

#1 Something called SD process: It instantly kills all lipid-enveloped

viruses. Every product on the market has something that kills

lipid-envelope viruses.

But that's only the lipid-enveloped viruses such as HIV, Hepatitis, West

Nile, SARS, etc. It does not include Parvo B19 - which is what causes

Parvo or Fifths Disease. Parvo has no lipid-envelope.

That virus and many others are not affected by the lipid envelope killers.

#2 Baxter has created a 35 nanometer filtration system. It filters out

anything greater than 35 nanometers.

Now, Parvo B19 is only 18 nanometers across. That's a problem - right?

No. The job of antibodies is to attach to germs. And that's what

happens to our little germ in the batch. Antibodies attach to it

readily -- it is a common germ and most everyone has antibodies against.

In a pool of 2000 donors you are going to have plenty of antibodies to

grab hold and that increases the size of the germ + antibodies to about

50 plus nanometers and therefore -- it won't pass the filter.

By the way, HIV virus is approximately 100 nanometers to start with --

so no, it doesn't get through either.

In addition to that, then Baxter has another checkpoint to absolutely

make sure nothing survives: that's a low pH bath at 90 degrees

temperature that kills both lipid-envelope and non-lipid envelope and it

stays there for 3 weeks. Just in case something got by the other

system. Which legally and theoretically could happen -- but proably

wouldn't.

So, Baxter has in place a triple purification system. But, in actuality

-- all IgG replacement therapies have similar methods of purification.

If you go to

http://www.plasmatherapeutics.org/en/qualitysafety_qseal.cfm

you can read about the required industry purification guidelines.

So... let's look at this statement that someone posted from a web-site.

" While the processes used to de-activate viral and bacterial agents has

drastically improved the safety of IVIG, it is not 100% fail

safe..... "

The first part of this statement is absolutely true. Until as recently

as 5 years ago this system was not complete and it allowed some unknown

viruses to slip through. Because of that the industry has responded

with more rigorous techniques to purify the IgG. So... it is

drastically improved recently. Yes.

The second half of that statement is also technically and theoretically

true. It is required by all legal departments just in case something

should arise that they have no knowledge about -- which DOES happen.

" there are still reported cases despite processes used. "

The man I talked with said that there is absolutely no reported cases of

lipid-based viruses being transmitted and he's checking with his

pathologist to see if there's any documented cases of Parvo being

transmitted by IgG since these new procedures have been in place. He'll

get back with me later.

" While the chances of transmitting something are extremely low, they

are, never-the- less, still there. "

That is also legally and theoretically true.

" The information is not limited to a single resource, if you query " IVIG

adverse reactions+parvovirus " , many reports come up that state the fact

that the products are not 100% safe....including safe from parvo. "

This statement is somewhat interesting. Many people lump IgG with all

other blood products. You have to be careful there. When you consider

what viruses can be routinely transmitted with whole blood or even

plasma -- you are talking about a whole 'nuther animal. Many blood

products contain viruses, including Parvo. It is almost " expected " that

you will transmit viruses with blood. But, IgG should not be lumped

with those products. I have not taken the time to query all these

reports. If someone finds one that is particularly troubling -- let me

know. I'll be glad to look. But, I've found that general searches on

the internet lead me to a lot of erroneous information. I want facts

backed by facts.

There is also one statement on the Quality of Blood Products web site

that may confuse doctors and/or patients. It states that plasma

donations are eliminated if they contain more than (I don't remember how

many) parts of Parvo virus per liter of plasma. But -- you say -- that

means there is Parvo virus in there! No. It means that they throw

away the initial donation if it has too much Parvo in it. Then it goes

through the process and while -- legally -- they can't claim to have it

100% gone -- they do claim to have reduced the amount by 10 to the 17

zeros place. So if you started out with a million parts -- you still

would have zero at the end. But not absolutely zero - legally and

theoretically!

So..... that's your chemistry lesson for today. I hope that it helps to

reassure somebody out there that IgG is not something that transmits

viruses and other crud. It's just not possible with today's system of

purification.

Have people been contaminated in the past -- oh yes!!!!! Could they

become contaminated in the future? Legally and theoretically, yes.

Probability wise -- probably not.

Hope that helps.

I'll post again whenever I hear from the pathologist at a major IgG

facility.

In His service,

dale