FDA approves first test to screen for Babesia in US blood supply
Press release from US Food and Drug Administration, March 6, 2018:
The U.S. Food and Drug Administration today approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microtiNucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples.
These tests are intended to be used as donor screening tests on samples from individual human donors, including volunteer donors of whole blood and blood components, as well as living organ and tissue donors.
“The U.S. blood supply remains the safest in the world thanks in part to the FDA’s ongoing work to enforce standards for blood collection and to identify and respond to potential threats to the nation’s blood supply. While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”
Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks.
B. microti is the main species that causes infection in the U.S. There are about 1,000 to 2,000 cases of babesiosis reported in the U.S. each year, with the majority reported from states in the Northeast and upper Midwest. Babesia can also be transmitted by transfusion of blood or blood components collected from an infected donor.
The vast majority of people infected with B. microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache and body aches.
The U.S. Centers for Disease Control and Prevention (CDC) warns that for certain people, especially those with a weak immune system, it can be a severe, life-threatening disease and that while blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the U.S. and remains an important concern.
The investigational use of Babesia donor testing has been in place since August 2012 in selected Babesia endemic areas under investigational new drug applications (INDs). The use of the investigational tests has resulted in the removal of a significant number of infected units from the blood supply.
The data collected from this testing and from additional studies performed by the manufacturer prevented the release of hundreds of potentially infectious donations and demonstrated that the tests are effective in screening donors for B. microti infection. The tests approved today are not intended for use in the diagnosis of babesiosis infections.
These applications were granted Priority Review, under which the FDA’s goal is to take action on an application within six months where the agency determines that the product, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
There currently is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue draft guidance with recommendations for reducing the risk of transfusion-transmitted babesiosis later this year.
The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.
How can they say Babesia is treatable and curable when thousands of chronic lyme ridden people are trying to get it cured and it doesn’t happen. I know if people really knew how much of the blood supply was already tainted, there would be mass hysteria. But if they are going to make a comment like that, they need to take a look at the lyme population. My son has been treating his chronic Babesia and Bartonella for years with no luck. And they mention Babesia, but what about Borrelia? Isn’t that more of a problem that also isn’t screened for.
Valerie Berk — Well, don’t you know that Lyme itself is curable with 2 weeks ABX, and in an extreme case 30 days. (Barf, laugh, sarcasm, tee hee hee.)
I feel terrible that I used to donate blood regularly, thinking I was doing a good thing–but after having neurological weirdness for a VERY LONG TIME, finally it moved into my gut, and I learned I had Lyme Disease and surely had it for well over 25 years. So sorry to anyone who got a transfusion from what I donated…
It’s not your fault. It’s the fault of our medical system for being in denial and our CDC not getting funds for research.
I stopped the organ donor message on my driver’s license now that I know I am infected.
So glad post mentioned organ donor–because I need to get it off of my ddriver’s license, too!
I agree with Valerie. Making the statement that Babesiosis is preventable and curable is laughable. My son has also been fighting Lyme and Babesia for over 7 years and has yet to be cured even after 2 yrs of oral and 6 months of IV antiobiotics. He is now starting the Buhner protocol for Babesia and we hope that he has better results.
When the Red Cross called me last year asking if I would donate blood, as I had done many times before, I told them I would not donate again until they had some type of screening for Babesia in place. Making this change is a good thing but please don’t insult our intelligence by making false statements about curing Babesia unless it is backed by treatment protocols and fact.
Tara, since we can’t trust that the test will be reliable and accurate, it’s best not to donate ever again. I’m not going to donate my blood or organs as planned. I changed my donor status last year.
Ditto. Plus what about B. duncanii? But this is a good start. They report 1 to 2 thousand cases reported each year (wow on the standard error bars there). They found “hundreds” of blood samples with B. microti. The Red Cross says less than 10 % of population donates blood. So if I play the sum game they report here, “hundreds” (I”ll arbitrairaly say 300) 300 blood sample upscaled to 100% of population is 3000 people with B. microti. Thats 1000 more cases than their highest estimate of reported cases. And I know my estimate is wrong because theres a lot I did not take into account. But still, its an alarming estimate, and I know there are some researchers looking at this with eyes wide and mouths open, knowing full well they should begin doing better monitoring
So if you have duncani or some other babesia species, you are still going to test negative and some recipient can still get babesiosis.
The test is a start but unfortunately, they have only approved a test ( reliable or not) for one species of Babesia. What about B. duncani? I hate sounding like Debbie Downer but I, like most Lyme patients, have little to no faith in our medical system – FOR GOOD REASON.
PS…. anything FDA approves should be seriously questioned since their initiatives are driven by special interests and not patients.
I’m glad they are working on the problem and I wish them Godspeed but the writer of the article has no idea if they think Babesia is easily cured. I got infected by Lyme, Babesia and Bartonella in Tanzania, Africa in November of 1997. I went 17 years undiagnosed and untreated although I saw tons of doctors and specialists over the years. I have been in treatment now for just over 3 years and have been told there is no cure for me. My Babesia symptoms were horrific. I now have them under control with Mepron. I can only take Mepron for so long then I must take a break as it causes problems for my kidneys. Everytime I go off Mepron I’m ok for a few weeks then slowly my symptoms return. The vibrations in my heart area, weakness, sweating, fatigue and bone pain being the worst. The whites of my eyes go red and I break out in hives. When I can’t take it any longer I go back on Mepron and within a few days I’m starting to feel better. I have tried other things for Babesia but in my personal case the only thing that works is Mepron. Hopefully now that they have figured out how to test the blood supply they will figure out how to test a person for the actual disease. Some inner voice inside me told me I shouldn’t be donating blood those 17 years I waited for a diagnosis. I’m so glad I listened.
If the FDA approved test is no more valid than the other Lyme tests, of what value is it? Perhaps the new test might be quickly approved, and used:
https://www.sciencedaily.com/releases/2018/02/180216110532.htm .
Passing Lyme via blood transfusion might well be a national emergency. A friend contracted Hepatitis C from a blood transfusion, was cured (by the VA), but the year long, chemo cure nearly killed him. All my Lyme tests came back negative; but, the herx from Flagyl (for cysts) and from follow up 60 day dose of Docycycline were quite bad. Do I have Lyme, or not – no one really knows, except that I still have many of the symptoms.
Sooo…no mention of B.duncanii, the more aggressive of the species? No mention of lyme or bartonella, the innumerable tick-borne infections that are ravaging the population?
But they say preventable and treatable. I went undiagnosed for ages and am currently on Mepron and Azithromycin and an array of naturals while watching my kidney and liver function anxiously, a few symptoms have subsided but I am still very sick, the temperature disregulation, exhaustion, pain, and just too many issues too list are still fluctuating and wreaking havoc everyday. This is not an easily treated disease and they are simply lying about that. I many others I see are still infected after years of treatment.
I also don’t see any mention of the detection rate or proof that these tests are adequate even for the one species of babesia. I hate to be negative over what may be progress but the false statements in a CDC press release and lack of details are upsetting.
Well, after reading all the posts here I must join everyone in being really surprised at how casual they make this seem. I have been donating blood for years…and for longer, have had Lyme/Babesia. I was finally diagnosed and treated for Lyme/Bab and who know what else only a year ago. Do the math. It will be a long journey I am sure, I share the Maldron/Azithro/Clithro etc. The list goes on and on, but the Lyme just hangs in there filling my days with pain , fatigue, you all know, the list is long. Have tried Byron White, Bhruner protocol and you name the herb, I’ve tried it. I am still nailed to my bedroom and dimness of my few small spaces. Life feel likes its over…I try and look forward but that, in itself scares me. The what next? I too watch Kidney/liver function, but what do you do when the only way up is through hell. CDC is no help, with the 2 weeks recommended course of Doxy in the ER’s here locally…and we are considered a NorthEastern Hot Spot….no spa here!!
Does it screen for co-infections too? I have lyme and co-infections. No evidence of tick bites or even on my dogs. But, I did have a blood transfusion in 2016…two bags. Possible or no?
Thanks.
yes, totally possible..that is what is article is about and why they are now screening the blood. What makes us lyme people laugh is the fact that the author of this article is saying babesia is curable. Let’s give the author a transfusion of the effect blood and see if they change their mind.
There is one really important fact which has not been mentioned. Most of the research docs at CDC are IDSA, and that will say it all re the tortoise-like speed which these “new” diseases are addressed. Note how quickly they got on the Zika virus or Ebola or any other infectious disease with only a few cases when compared to LD and co-infections. The only real way to get their attention is if they get it themselves or a close family member does. Otherwise, they have proven time and again that they just don’t think there is any priority. Absolutely, the blood supply must be screened for LD plus several co-infections. I will refuse to get a transfusion, OR to donate my contaminated blood.
I have seen more people with Babesia duncani. How many years til they actually thoroughly test the supply? What about the 13 strains of Bartonella or however many they know about?