Norwood, MA, United States
Norwood, MA, United States

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PubMed | Imugen Inc., Nantucket Cottage Hospital, Hunterdon Medical Center Infectious Diseases, Hawthorn Medical Associates and Tufts University
Type: Journal Article | Journal: Clinics in laboratory medicine | Year: 2015

Borrelia miyamotoi disease (BMD) is a newly recognized borreliosis globally transmitted by ticks of the Ixodes persulcatus species complex. Once considered to be a tick symbiont with no public health implications, B miyamotoi is increasingly recognized as the agent of a nonspecific febrile illness often misdiagnosed as acute Lyme disease without rash, or as ehrlichiosis. The frequency of its diagnosis in the northeastern United States is similar to that of human granulocytic ehrlichiosis. A diagnosis of BMD is confirmed by polymerase chain reaction analysis of acute blood samples, or by seroconversion using a recombinant glycerophosphodiester phosphodiesterase enzyme immunoassay. BMD is successfully treated with oral doxycycline or amoxicillin.

Chowdri H.R.,Hawthorn Medical Associates | Gugliotta J.L.,Hunterdon Medical Center | Berardi V.P.,IMUGEN Inc. | Goethert H.K.,Tufts University | And 3 more authors.
Annals of Internal Medicine | Year: 2013

Background: The diverse tickborne infections of the northeastern United States can present as undifferentiated flu-like illnesses. In areas endemic for Lyme and other tickborne diseases, patients presenting with acute febrile illness with myalgia, headache, neutropenia, thrombocytopenia, and elevated hepatic aminotransferase levels are presumptively diagnosed as having human granulocytic anaplasmosis (HGA). Objective: To assign a cause for illness experienced by 2 case patients who were initially diagnosed with HGA but did not rapidly defervesce with doxycycline treatment and had no laboratory evidence of Anaplasma phagocytophilum infection. Design: Case report. Setting: 2 primary care medical centers in Massachusetts and New Jersey. Patients: 2 case patients acutely presenting with fever. Measurements: Identification of the causative agent by polymerase chain reaction and DNA sequencing. Results: Molecular diagnostic assays detected Borrelia miyamotoi in the peripheral blood of both patients. There was no evidence of infection with other tickborne pathogens commonly diagnosed in the referral areas. Limitation: One of the case patients may have had concurrent Lyme disease. Conclusion: The presence of B. miyamotoi DNA in the peripheral blood and the patients' eventual therapeutic response to doxycycline are consistent with the hypothesis that their illness was due to this newly recognized spirochete. Samples from tick-exposed patients acutely presenting with signs of HGA but who have a delayed response to doxycycline therapy or negative confirmatory test results for HGA should be analyzed carefully for evidence of B. miyamotoi infection. © 2013 American College of Physicians.

Young C.,Rhode Island Blood Center | Young C.,Hasbro Childrens Hospital of Rhode Island | Young C.,Imugen Inc. | Young C.,Women and Infants Hospital | And 32 more authors.
Transfusion | Year: 2012

BACKGROUND: Babesiosis is the most common transfusion-transmitted infection reported to the Food and Drug Administration (FDA). We developed and implemented the first laboratory-based blood donor screening program for Babesia microti to help reduce and prevent transfusion-transmitted babesiosis (TTB) and report results for the initial year. STUDY DESIGN AND METHODS: Selective B. microti donor screening was performed using real-time polymerase chain reaction (PCR) and indirect immunofluorescence assay (IFA) to reduce the incidence of TTB in neonates and pediatric sickle cell and thalassemia patients under an FDA-approved investigational new drug application. We compared the reports of TTB in these patients in the first 12 months of the study with those of patients who received unscreened blood from 2005 to 2010. RESULTS: There were 2113 units tested with 2086 negative results, 26 positive IFA results (1.23%), and one indeterminate PCR result (0.05%). No reported case of TTB occurred with any B. microti-screened unit transfused to the targeted patients (0/787 units) or to any patient who received the screened units (0/2086 units). Before screening, there were seven cases of TTB in neonates, sickle cell, and thalassemia patients from 6500 unscreened units (one case/929 units) and 24 cases in the total transfused population from 496,545 units distributed (one case/20,686 units). CONCLUSION: Implementation of B. microti IFA and PCR screening is compatible with blood center operations to provide tested units. While the results after 1 year are not powered to demonstrate a change in the rate of TTB after testing, they are encouraging. © 2012 American Association of Blood Banks.

Moritz E.D.,Red Cross | Winton C.S.,Red Cross | Johnson S.T.,Red Cross | Krysztof D.E.,Red Cross | And 7 more authors.
Transfusion | Year: 2014

BACKGROUND: Babesia microti, a transfusiontransmissible intraerythrocytic parasite, is increasing in frequency in the United States with no available FDAlicensed donor screening assay. We utilized investigational arrayed fluorescence immunoassay (AFIA) and polymerase chain reaction (PCR) to detect B. microti antibodies and DNA in blood donors. STUDY DESIGN AND METHODS: AFIA and real-time PCR were performed on frozen paired EDTA plasma (AFIA) and EDTA whole blood (PCR) samples collected from May to September 2010 to 2011 in nonendemic (Arizona [AZ] and Oklahoma [OK]), moderately endemic (Minnesota [MN] and Wisconsin [WI]), and highly endemic (Connecticut [CT] and Massachusetts [MA]) areas of the United States. AFIA utilized B. microti piroplasm as an antigen substrate; PCR primers and probes targeted the B. microti 18S ribosomal RNA gene. Data from AZ and OK were used to calculate specificity. All AFIA- or PCR-positive or -inconclusive donors were deferred, notified, and invited to participate in a follow-up study involving repeat testing and a demographic and risk-factor questionnaire. Recipient tracing was performed for any cellular component transfused at index, at subsequent donation, or within the prior 12 months. RESULTS: Testing of 13,269 paired samples included 4022 from AZ and OK, 4167 from MN and WI, and 5080 from CT and MA. B. microti antibody and/or DNA prevalences were 0.025% (95% confidence interval [CI], 0.00%-0.14%), 0.12% (95% CI, 0.04%-0.28%), and 0.75% (95% CI, 0.53%-1.03%) in the nonendemic, midendemic, and high-endemic regions, respectively. Specificities were 99.95% (95% CI, 99.82%-99.99%) at a 1-in-64 AFIA cutoff and 99.98% (95% CI, 99.86% 100.00%) at a 1-in-128 cutoff. CONCLUSIONS: B. microti prevalence followed expected geographical patterns. Screening was feasible with a performance comparable or superior to other infectious disease blood donor screening assays. © 2014 AABB.

Townsend R.L.,Red Cross | Moritz E.D.,Red Cross | Fialkow L.B.,Red Cross | Berardi V.,IMUGEN Inc. | Stramer S.L.,Red Cross
Transfusion | Year: 2014

Background Anaplasma phagocytophilum (AP), a tick-borne obligate intracellular bacterium, causes human granulocytic anaplasmosis (HGA) and has been implicated in seven transfusion-transmitted (TT)-HGA cases associated with red blood cells (RBCs). Here we report the first probable case of TT-HGA involving leukoreduced platelets (PLTs). Case Report A hospitalized male received 25 blood components (November 2012) before his death from trauma. Hospital testing confirmed HGA by peripheral blood smears; samples were also sent to IMUGEN, Inc. (Norwood, MA), for AP-polymerase chain reaction (PCR) and AP-immunoglobulin (Ig)M and IgG enzyme immunoassay. All 12 potentially transmitting donors provided follow-up samples.Results Recipient smears progressed from negative to predominantly positive 16 days posttransfusion; hospital-performed AP-PCR was positive on Day 22. IMUGEN sample testing was PCR positive and IgM and IgG negative 14 to 23 days posttransfusion. The recipient had no known AP risk factors. One of 12 donors of RBCs or PLTs (leukoreduced 5-day-old PLTs) provided six follow-up samples; all were strongly IgG positive and IgM negative; one was PCR-positive. The IgG-positive donor was a 52-year-old female from Hudson Valley, New York, an area endemic for AP. She reported tick bites in September to October 2012 with no travel outside New York. The donor remained asymptomatic and received no treatment. The cocomponent PLT unit was transfused to a 78-year-old male who died of causes unrelated to AP.Conclusions This eighth case of probable TT-HGA indicates that leukoreduced PLTs may be infectious. An antibody- and PCR-positive donor having prior tick exposure living in an endemic area was identified. PCR positivity and elevated IgG levels, which continue to exceed the assay's detectible range even in the absence of IgM, indicate active donor infection. © 2014 AABB.

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