What's up with Chagas Blood Donor testing?

[kmar]

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I. INTRODUCTION

Page Last Updated: 12/07/2010

We, FDA, are issuing this guidance to notify you, establishments that manufacture Whole Blood and blood components intended for transfusion, about FDA approvals of Biologics License Applications (BLAs) for serological test systems for the detection of antibodies to Trypanosoma cruzi (T. cruzi). These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors. This guidance does not apply to establishments that make eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Also, this guidance document does not apply to the collection of Source Plasma.
In addition, we are providing you with recommendations for testing donations of Whole Blood and blood components for evidence of T. cruzi infection, blood donor and product management, labeling of Whole Blood and blood components, and procedures for reporting the implementation of a licensed T. cruzi test at your facility or at your contract testing laboratory, as required for licensed manufacturers of blood and blood components under Title 21 Code of Federal Regulations 601.12 (21 CFR 601.12).

This guidance finalizes the draft guidance entitled, “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” dated March 2009.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.

The presence of the pathogenic agent in U.S. and Canadian donors is increasing due to immigration of infected individuals from endemic areas. Experts estimate that there may be as many as 300,000 persons unknowingly infected with T. cruzi, who reside in the U.S. and Canada (Ref. 2).

Vector-borne T. cruzi infections are mostly mild in the acute phase and then persist throughout life, usually without symptoms. Acute infection in patients with compromised immune systems, for example, from cancer therapy or organ transplantation, can be very serious and sometimes fatal.

Treatment options are limited, but are most effective early in the infection. The lifetime risk of severe cardiac complications (cardiomegaly, heart failure and arrhythmias) or intestinal disorders (megacolon, megaesophagus) in infected individuals averages about 30% (range of 10 to 40% depending on a variety of factors) and may occur decades after the initial infection.

During the acute phase of vector-boDuring this phase, parasites have been demonstrated in muscle (especially cardiac muscle), nerves, and digestive tract, rne Chagas disease, parasites are found in skin lesions at the site of transmission.

The parasites are then spread through the bloodstream to various tissues, particularly skeletal muscle (Ref. 4).

During the chronic stage of Chagas disease, most persons who harbor the parasite are asymptomatic and unaware of their infection. but there has been very little investigation of tissue distribution or mobilization into the circulating blood during the chronic phase

III. RECOMMENDATIONS

Blood Donor Testing and Management

Identify Donors with a History of Chagas Disease
We recommend that you ask the following question to all donors at each donation, to identify donors with a history of Chagas disease:
“Have you ever had Chagas disease?” 3

You should indefinitely defer donors who answer “yes” to this question.
Donor Testing

We recommend one time testing of each donor of allogeneic units of blood using a licensed test for antibodies to T. cruzi.4 Donors who test nonreactive are qualified to return to donate without further testing of subsequent donations for antibodies to T. cruzi. Each blood establishment should review its records5 to determine the history of testing for T. cruzi in prospective donors to determine whether a donor should be tested.

We also recommend one time testing of autologous blood donors using a licensed test for antibodies to T. cruzi when the circumstances described in 21 CFR 610.40(d)(1) through (3) are applicable.
Donor Deferral

We recommend that all donors who test repeatedly reactive on a licensed test for T. cruzi antibody or who have a history of Chagas disease should be indefinitely deferred and notified of their deferral.

Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

[tcmgpt13]

Remember when we all had the discussion about chagas being found in the US blood supply back in October of 2007? The CDC has known about this for ages and yet we with lesions are not encouraged to be tested for this illness. Talk about a crock and a half. I have to wonder if any testing for this disease was ever done by Kaiser?:

Blood supply in US has Chagas parasite

[Venetia]

This brought to mind the recent news about the New York bed bug issue.

Chagas is vectored by the bed bug among other parasites...


Symptoms- Chagas

Chagas disease: Symptoms - MayoClinic.com

[kmar]

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Blood donations from individuals from endemic areas are the primary source of risk for T. cruzi infection from transfusion. Studies in the mid-1990s (Ref. 15) estimated that the rate of seropositive blood donors in the U.S. ranged from 1 in 5,400 to 1 in 25,000, largely depending on the proportion of immigrants from Chagas endemic areas present in the population where the studies were conducted.

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Yes..... bed bugs definitely could be a vector!



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[tcmgpt13]

V, I wonder if you have you found reference to the bed bug as a vector for anything, including chagas. All I can find is a lot of denial about any sort of disease being spread by bed bugs, so you can see why I would be extremely interested in reading about someone who would say this about Chagas. I cannot believe they don't carry something, as they are known to carry so many diseases and yet this "story" continues to be told by references all over the net: bedbugs do not cause disease.

[tcmgpt13]

Well, did a bit more digging and did find one reference to bedbugs spreading hepatitis B and possibly Chagas. The article was referenced in one on emedicine (I don't have access to the paid article and no information other than the title, author is given on pubmed) and dates from 1969, over forty years ago. I guess there's no real proof yet, but you have to wonder why this has not been suspected and tested for in every person who has Morgellons lesion and lyme:

Bedbugs may be a vector for hepatitis B6 and, in endemic areas, for American trypanosomiasis (Chagas disease).7 Of note, reports have indicated the risk of insect transmission of HIV, if any, is extremely low and likely nonexistent.8,9

Pipkin AC Sr. Transmission of Trypanosoma cruzi by arthropod vectors: anterior versus posterior route infection. Int Rev Trop Med. 1969;3:1-47. [Medline].

"There is some evidence that bedbugs may also be a vector for hepatitis B and Chagas disease. Histologic findings from bite-site biopsy specimens typically show eosinophilic infiltrates, which are indicative of the allergic nature of the reaction."

Bedbug Bites: eMedicine Dermatology

An old thread about leishmaniasis which is sometimes found in people who also have Chagas disease:

Cutaneous Leishmaniasis, Lesions, and Sand flies and Morgellons

This is an article about a new way to treat the combined infections of leishmania and Chagas disease. In it there is also discussion of how these two infections sometimes are found in the same person. You will see here that in the diffuse cutaneous form of leishmaniasis has both many lesions and a specific T-cell immunodeficiency in the host. So why are we not being tested for both leishmaniasus and Chagas disease? What is not being done to help us is appalling. Does it truly cost that much to test say twenty five people to find out if any of this is an issue? Or are they too busy hiding it due to political considerations?

Concurrent Chagas? disease and borderline disseminated cutaneous leishmaniasis: The role of amiodarone as an antitrypanosomatidae drug

[Venetia]

Kmar,

The news you post is shocking!

From your posted link:

Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

Excerpt:

The presence of the pathogenic agent in U.S. and Canadian donors is increasing due to immigration of infected individuals from endemic areas. Experts estimate that there may be as many as 300,000 persons unknowingly infected with T. cruzi, who reside in the U.S. and Canada (Ref. 2).

and this:

Studies in the mid-1990s (Ref. 1) estimated that the rate of seropositive blood donors in the U.S. ranged from 1 in 5400 to 1 in 25000,largely depending on the proportion of immigrants from Chagas endemic areas present in the population where the studies were conducted.

(well there is a clue as to the source of the problem)

That, from the mid-1990's ? Imagine what it could really be now- exponentially? And the public was not informed?


I found it equally surprising to learn that Chagas is not reportable:

http://www.doh.state.fl.us/environme...9TickGuide.pdf

Scroll down to page 32

CHD Information

Chagas disease is not reportable.


***




TCM,

Agree with you that the stories all over the net are all about denial of disease vectored by bedbugs. Sets off the old hinkymeter.

Seems logical with the epidemic of bedbugs- first on the east coast and now most everywhere, that the media would go into hyper-denial mode. Seems our government would like us to gracefully accept the massive influx of illegals. My first clue was the lawsuit against Arizona as relates to the issue.

It also seems that there is a direct correlation between the increase in illegals in the US and the increase in disease in the US.

Bed Bugs Symptoms, Causes, Treatment - What about bed bugs in hotels on MedicineNet

Excerpt:

Bed bugs have not been conclusively proven to carry infectious microbes. However, researchers have implicated bed bugs as possible vectors of American trypanosomiasis (Chagas disease), and studies are ongoing to determine whether bed bugs may serve as disease carriers.


Attack of the Mexican Bed Bug - Associated Content from Yahoo! - associatedcontent.com

Excerpt:

Well, ladies and gentlemen, I was just attacked by a Kissing Bug, also known as an Assassin Bug or Mexican Bed Bug. These nasty little creatures thrive off of the blood of the innocent, and I just happened to be dinner at that particular moment. It turns out, as we quickly researched on the Internet, these little buggers (pardon the pun) can carry Chagas disease, a kind of parasite that invades the heart. I guess it is very prevalent in Mexico as 21,000 people a year die from it. And 40% of these nasty devils carry this parasite so I am going to the doctor on Thursday to have my blood evaluated. Hopefully I don't have it, because if I do, I will have to take anti-parasitic drugs to make it go away.




Parasites November24.info

Excerpt:

A parasite is a creature that needs other creatures to remain alive, to feed or reproduce mostly, they, parasites, are generally Insects, arachnids, or other kind of small, or very small animals using others to get what’s needed.

They are, for Humans: Bed bug: From which we can get chagas disease: An infectious disease found mostly in poor Countries.


Source “C.D.C”, “N.I.H”, “Wikipedia”.


What Are Bed Bugs? How To Kill Bed Bugs

Scroll down to:

Excerpt

Do bed bugs transmit disease?


Researchers have concluded that they are much less hazardous to human health than fleas, or other common insects. Nevertheless, these are well formulated opinions, rather than the results of conclusive studies. Some say hepatitis B or Chagas disease could not be discarded as possibilities if the setting were right.



Habitat Fragmentation, Biodiversity, and Disease Emergence|ENGLISH ARTICLES

Excerpt:

Predators also tend to be absent in small woodlots, and probable competitors occur at lower densities in these areas than in more continuous habitat. Therefore, habitat fragmentation causes a reduction in biodiversity within
the host communities, increasing disease risk though the increase in both the absolute and relative density of the
primary reservoir. Other diseases are known to have resurged following land use change, including cutaneous leishmaniasis, Chagas disease, human granulocytic ehrlichiosis, babesiosis, plague, louping ill, tularemia, relapsing fever, Crimean-Congo hemorrhagic fever, and La Crosse virus.

end excerpts


Went back to find the source of my info and it eludes me- will post if and when if re-find it.

What I was really looking for (prior to posting about the bed-bugs and Chagas) was an article that I found and then lost about Lyme as it relates to Chagas.


~V~

[Venetia]

Opps, TCM- I see I posted one of the same Chagas/bedbug links that you just posted. Sorry.

I have to quit with the long posts!

~V~

[lamb]

Hmmm. Fits my profile as well. 1991 first episode...three months in duration.
Hmmm.

[cynical]

Major breakthrough in the diagnosis of parasitic diseases

I am very concerned about this considering we live in what could become a epidemic area.

Hope they start to take the risk serious soon. They demand tb test for school entrance why not other life threatening diseases.


Cyn