Cost‐effectiveness of <i>Babesia microti</i> antibody and nucleic acid blood donation screening using results from prospective investigational studies

Bish, Ebru K.; Moritz, Erin D.; El‐Amine, Hadi; Bish, Douglas R.; Stramer, Susan L.

doi:10.1111/trf.13136

Cited by 30 publications

(30 citation statements)

References 26 publications

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“…Detection of window period infections would require methods other than serology, such as PCR or other direct parasite detection techniques, with the attendant relatively significant incremental cost. 38,39 However, even PCR is subject to limitations in sensitivity dependent on the target selected and on sample volume, which may vary between assays, and is capable of yielding false-negative results, in particular at low levels of parasitemia. 15 Volumes of whole blood utilized in published B. microti PCR protocols range from 200 mL to 2.0 mL, with corresponding analytical sensitivities ranging between 10 and 100 gene copies per PCR procedure.…”

Section: Discussionmentioning

confidence: 99%

Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

Levin

Williamson²,

Bloch

et al. 2016

Transfusion

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BACKGROUND The tick-borne pathogen Babesia microti has become recognized as the leading infectious risk associated with blood transfusion in the United States, yet no Food and Drug Administration–licensed screening tests are currently available to mitigate this risk. The aim of this study was to evaluate the performance of an investigational enzyme immunoassay (EIA) for B. microti as a screening test applied to endemic and nonendemic blood donor populations. STUDY DESIGN AND METHODS The study aimed to test 20,000 blood donors from areas of the United States considered endemic for B. microti and 10,000 donors from a nonendemic area with the investigational B. microti EIA. Repeat-reactive samples were retested by polymerase chain reaction (PCR), blood smear, immunofluorescent assay (IFA), and immunoblot assay. In parallel, serum samples from symptomatic patients with confirmed babesiosis were tested by EIA, IFA, and immunoblot assays. RESULTS A total of 38 of 13,757 (0.28%) of the donors from New York, 7 of 4583 (0.15%) from Minnesota, and 11 of 8363 (0.13%) from New Mexico were found repeat reactive by EIA. Nine of the 56 EIA repeat-reactive donors (eight from New York and one from Minnesota) were positive by PCR. The specificity of the assay in a nonendemic population was 99.93%. Among IFA-positive clinical babesiosis patients, the sensitivity of the assay was 91.1%. CONCLUSION The B. microti EIA detected PCR-positive, potentially infectious blood donors in an endemic population and exhibited high specificity among uninfected and unexposed individuals. The EIA promises to provide an effective tool for blood donor screening for B. microti in a format amenable to high-throughput and cost-effective screening.

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Section: Discussionmentioning

confidence: 99%

Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

Levin

Williamson²,

Bloch

et al. 2016

Transfusion

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“…The economic impact assessment team noted that since 2014, three studies have been conducted on the cost effectiveness of B. microti screening with highly variable cost‐effectiveness results ranging from $54,000 to $83,000/quality‐adjusted life‐year (QALY) to $5.2 million/QALY and $8.8 million/QALY . Rather than undertake further cost‐effectiveness, we conducted an analysis of the number of infectious units that would be removed from the system through various testing methods and the cost of prevention.…”

Section: Assessing the Risk And Risk Management Options (Rbdm Stage 4)mentioning

confidence: 99%

Assessing the risk of Babesia to the United States blood supply using a risk‐based decision‐making approach: Report of AABB's Ad Hoc Babesia Policy Working Group (original report)

2018

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Recognizing the increasing threat of transfusion-transmitted babesiosis to the US blood supply, the AABB Board of Directors tasked an Ad Hoc Babesia Policy Working Group (the Working Group) to use the Alliance of Blood Operators' risk-based decision-making (RBDM) framework to assess the risks and benefits of introducing Babesia donation testing in the United States. The regional nature of the Babesia microti risk added complexity to the RBDM assessment because of the unique operational and financial considerations for operators and hospitals located in endemic states. Therefore, the assessment considered safety, product availability, sector sustainability, and technology availability. After assessing safety risk, economic and operational impact, reimbursement equity, ethical considerations, and stakeholder feedback from two consultations, the Working Group concluded that a regional approach to donor screening in endemic states was appropriate because it applied the intervention where the risk was highest and appropriately allocated cost to the risk. Nucleic acid testing using a ribosomal RNA template was the recommended intervention because it was the most cost-effective, resulted in no wasted units, and captured similar numbers of infections as antibody plus DNA-based polymerase chain reaction. The current model for blood reimbursement was maintained but AABB was encouraged to facilitate collection of data to identify threats to sector sustainability in endemic states. Babesia expansion was acknowledged with a mechanism to regularly reevaluate what are "endemic states." Finally, given that public awareness of the Babesia threat is the first line of defense, AABB should work with appropriate agencies for general education about the health risk from B. microti.

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“…Although their numbers may be low, these individuals show that PCR testing by itself will not always detect active infection. Accordingly, donor screening models have been proposed incorporating both serology and PCR [36,37]. …”

Section: Diagnostic and Screening Tests For Ttbmentioning

confidence: 99%

“…Each has arrived at different conclusions regarding the cost effectiveness of TTB screening for similar programs. Two studies found that effective programs could be devised that would cost less than the 1 million dollars per QALY threshold [37,48]. One of these found that universal donor antibody screening for B. microti in endemic areas of the US is the most promising approach while the other found that universal PCR in four endemic states would be most cost effective.…”

Section: Cost Effectiveness Of Screeningmentioning

confidence: 99%

Transfusion-transmitted babesiosis: is it time to screen the blood supply?

Levin

Krause

2016

Current Opinion in Hematology

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Purpose of review To summarize the current status of blood screening to prevent transfusion-transmitted babesiosis. Recent findings Babesia microti has recently been determined to be the most common transfusion-transmitted pathogen in the United States. Patients who acquire transfusion transmitted babesiosis (TTB) often experience severe illness with an associated mortality rate of about 20%. Recent studies have demonstrated that laboratory screening using B. microti antibody and/or PCR assays can effectively identify infectious blood donors and that this approach may offer a cost effective means of intervention. Pathogen inactivation methods may offer an alternative solution. None of these methods has yet been licensed by FDA, however, and current efforts to prevent TTB rely on excluding blood donors who report having had babesiosis. Summary TTB imposes a significant health burden on the US population. Further research is needed to better inform decisions on optimal screening strategies and reentry criteria, but given the acute need and the currently available screening tools, initiation of blood donor screening to prevent TTB should be given high priority.

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Cost‐effectiveness of Babesia microti antibody and nucleic acid blood donation screening using results from prospective investigational studies

Abstract: Universal PCR in endemic states is an effective blood donation screening strategy at a threshold of $50,000/QALY. Using a higher cost-effectiveness ratio, universal Ab/PCR is the most effective strategy.

Cited by 30 publications

References 26 publications

Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

Assessing the risk of Babesia to the United States blood supply using a risk‐based decision‐making approach: Report of AABB's Ad Hoc Babesia Policy Working Group (original report)

Transfusion-transmitted babesiosis: is it time to screen the blood supply?

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