Evidence map›Paper›PMID 27224258›Full record

ArticleTransfusion2016

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

Andrew E Levin, Phillip C Williamson, Evan M Bloch, Joan Clifford, Sherri Cyrus, Beth H Shaz, Debra Kessler, Jed Gorlin, James L Erwin, Neil X Krueger and 9 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Transfusion, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03056378 (Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03056378 phase1withdrawnnot on this mapstarted 2019, after this paper: background citation

Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion

TypeinterventionalSponsorNew York Blood CenterRan2019 to 2021Enrolled0ConditionsTransfusion Reaction, AnemiaArmsStandard RBCs
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Global meta-analysis onPathogens and global health · 2022
    Pooled it
  2. Babesiosis and Its Significance in Transfusion Medicine from a European Point of View.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Review
  3. Article
  4. Transfusion-transmittedJournal of clinical microbiology · 2023
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Technologies for Detection ofPathogens (Basel, Switzerland) · 2021
    Review
  10. Article
  11. The Global Emergence of Human Babesiosis.Pathogens (Basel, Switzerland) · 2021
    Review
  12. Preventing Transfusion-Transmitted Babesiosis.Pathogens (Basel, Switzerland) · 2021
    Review
  13. Frontiers in microbiology · 2021
    Review
  14. Article
  15. Article
  16. Persistence ofPathogens (Basel, Switzerland) · 2019
    Review
  17. Article
  18. Article
  19. Article
  20. The American journal of tropical medicine and hygiene · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 10 institutions in 1 country.

Andrew E LevinImmunetics, Inc., Boston, Massachusetts.
Phillip C WilliamsonCreative Testing Solutions, Tempe, Arizona.
Evan M BlochBlood Systems Research Institute, San Francisco, California.
Joan CliffordImmunetics, Inc., Boston, Massachusetts.
Sherri CyrusCreative Testing Solutions, Tempe, Arizona.
Beth H ShazNew York Blood Center, New York, New York.
Debra KesslerNew York Blood Center, New York, New York.
Jed GorlinInnovative Blood Resources/Memorial Blood Centers, St Paul, Minnesota.
James L ErwinImmunetics, Inc., Boston, Massachusetts.
Neil X KruegerImmunetics, Inc., Boston, Massachusetts.
Greg V WilliamsImmunetics, Inc., Boston, Massachusetts.
Oksana PenezinaImmunetics, Inc., Boston, Massachusetts.
Sam R TelfordTufts University Cummings School of Veterinary Medicine, North Grafton, Massachusetts.
John A BrandaMassachusetts General Hospital, Boston, Massachusetts.
Peter J KrauseYale School of Public Health and Yale School of Medicine, New Haven, Connecticut.
Gary P WormserNew York Medical College, Valhalla, New York.
Anna M SchotthoeferMarshfield Clinic, Marshfield, Wisconsin.
Thomas R FritscheMarshfield Clinic, Marshfield, Wisconsin.
Michael P BuschBlood Systems Research Institute, San Francisco, California.
Immunetics (United States) · USMarshfield Clinic · USNew York Blood Center · USBlood Systems Research Institute · USJohns Hopkins Medicine · USMassachusetts General Hospital · USMemorial Blood Centers · USNew York Medical College · USTufts University · USYale University · US

Funding

NHLBI NIH HHS HHSN268201000047C
6 · The paper itself

Abstract

backgroundThe 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

methodsThe 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.

resultsA 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%.

conclusionThe 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.

Indexed as

Blood DonorsAdolescentAdultAgedAged, 80 and overBabesia microtiBabesiosisEndemic DiseasesFemaleHigh-Throughput Screening AssaysHumansImmunoenzyme TechniquesMaleMass ScreeningMiddle AgedSerologic Tests

Identifiers

PMID27224258
PMCPMC6007971
OpenAlexW2400230223

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.