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FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply


FDA approves first tests to screen for tickborne parasite in blood donations
fda.gov
 
 
Co-infection with Babesia is a significant risk factor in our practice for increasing the severity and duration of illness. The FDA just released the first tests to screen for Babesiosis in the blood supply and plasma, and this very good news, as a prior study several years ago found that 4/1000 blood transfusions contained Babesiosis. Those who are very young or elderly, and immunosuppressed (or without a spleen) are at greatest risk.
Apart from using antibody testing and PCR in our practice, we have found that the 18s rRNA test (FISH test) is very helpful for patients who are Babesia microti negative/PCR negative (Detection of Babesia microti parasites by highly sensitive 18S rRNA reverse transcription PCR. Hanron AE, Billman ZP, Seilie AM, Chang M, Murphy SC. Diagnostic Microbiology & Infectious Disease. 2016 Dec 5. pii: S0732-8893(16)30405-9). We also find a significant percentage of our patients test positive for other species, like B. duncani/WA-1. We did a study in our office on Babesia testing years ago using LabCorp, and found that 19% of our patients from the Northeast tested positive for Babesia duncani when testing for B. microti was negative (LabCorp Babesia duncani/WA 1 total tests @ Hudson Valley Healing Arts Center June 2010-July 2011: out of 137 total tests, positive results 26/137 = 19 %). Regions of the US tested positive from Hamlin, Maine to Winter Park, Florida (the entire northeast seaboard). Often FISH/rRNA testing (which picks up multiple species of Babesia) is positive when other testing is negative. What else can we do to help diagnose Babesia?
When patients come in to see us, they fill out the HMQ Lyme questionnaire. We use it as a screening questionnaire to establish pre-test probability for Lyme and co-infections, and two of the questions on the Horowitz MSIDS questionnaire (HMQ) relate to symptoms of Babesiosis. Here is the excerpt from the paper we recently published (Empirical Validation of the Horowitz Multiple Systemic Infectious Disease Syndrome Questionnaire for Suspected Lyme Disease. Maryalice Citera1¶*, Ph.D., Phyllis R. Freeman2¶, Ph.D., Richard I. Horowitz2¶, M.D., International Journal of General Medicine 2017:10 249–273):
"Other tick-borne infections like babesiosis should also be considered in severely ill patients (73) since it is frequently transmitted at the same time as borreliosis. (74) Any patient who complains of unexplained fevers, day and night sweats, chills, flushing, an unexplained cough, and shortness of breath (air hunger), which are questions number 1 and number 22 (Section 1 of the HMQ), may also have a concomitant infection with babesiosis (75–77) A Babesia panel approach with a Giemsa stain, Babesia titers (IFA) for multiple species of Babesia (Babesia microti, Babesia duncani [WA-1, Babesia divergens and Babesia sp. EU1]), with PCR [61] and FISH testing, may help to establish the diagnosis(78) in the United States and Europe (78) while ruling out other causes of these symptoms.
[74. Hersh MH, Ostfeld RS, McHenry DJ, et al. Co-infection of blacklegged ticks with Babesia microti and Borrelia burgdorferi is highervthan expected and acquired from small mammal hosts. PLoS One. 2014;9(6):e99348]
[75. Eleftherios M. When to suspect and how to monitor babesiosis. Am Fam Physician. 2001;63(10):1969–1975].
[76. Horowitz ML, Coletta F, Fein AM. Delayed onset adult respiratory distress syndrome in babesiosis. Chest. 1994;106(4):1299–1301].
[77. Knapp KL, Rice NA. Human coinfection with Borrelia burgdorferi and Babesia microt in the United States. J Parasitol Res. 2015;2015:1– 11]
[78. Lempereur L, Shiels B, Heyman P, et al. A retrospective serological survey on human babesiosis in Belgium. Clin Microbiol Infect. 2015;21(1):96.e1–e7]
It is important to look for Babesiosis (and other co-infections like Bartonella) if you have Lyme and have not gotten adequate help with standard treatment protocols. This is a very good first step by the FDA to help decrease the risk of acquiring Babesiosis.
https://www.fda.gov/…/News…/PressAnnouncements/ucm599782.htm
Disclaimer: The views expressed are those of Dr Richard Horowitz, and do not represent the views of the Tick-Borne Disease Working Group, HHS or the United States