Evidence map›Paper›PMID 34368968›Full record

ArticleTransfusion2021

Detection of Babesia RNA and DNA in whole blood samples from US blood donations.

Jean Stanley, Susan L Stramer, Yasuko Erickson, Julie Cruz, Jed Gorlin, Mark Janzen, Susan N Rossmann, Todd Straus, Patrick Albrecht, Lisa Lee Pate and 2 more

Open access · hybridAbstract read
In one paragraph

Article in Transfusion, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 24 citations in OpenAlex.

  1. Guidance on the Management of Asymptomatic Blood Donors Who Test Positive for Babesia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  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. More than malaria: ExploringCurrent research in parasitology & vector-borne diseases · 2026
    Review
  5. Article
  6. Review
  7. Review
  8. How to Detect Antibodies AgainstOpen forum infectious diseases · 2024
    Article
  9. Coinfection ofPathogens (Basel, Switzerland) · 2024
    Review
  10. Article
  11. Transfusion-transmittedJournal of clinical microbiology · 2023
    Review
  12. Article
  13. Molecular Screening of Blood Donors forTransfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2023
    Article
  14. Article
  15. Transfusion-Transmitted Malaria and Mitigation Strategies in Nonendemic Regions.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2022
    Review
  16. Article
  17. In Silico Survey and Characterization ofPathogens (Basel, Switzerland) · 2021
    Article
  18. Article
  19. Preventing Transfusion-Transmitted Babesiosis.Pathogens (Basel, Switzerland) · 2021
    Review
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

12 authors at 8 institutions in 3 countries.

Jean StanleyClinical Development and Medical Affairs, Roche Molecular Systems, Inc., Pleasanton, California, USA.ORCID 0000-0002-9182-9281
Susan L StramerScientific Services, American Red Cross, Gaithersburg, Maryland, USA.ORCID 0000-0002-5865-6366
Yasuko EricksonMedical Affairs, ImpactLife, Davenport, Iowa, USA.
Julie CruzMedical Science Institute, Versiti Blood Center, Indianapolis, Indiana, USA.
Jed GorlinPhysician Services, Innovative Blood Resources, St. Paul, Minnesota, USA.
Mark JanzenLaboratory Services, Innovative Blood Resources, St. Paul, Minnesota, USA.
Susan N RossmannMedical Services, Gulf Coast Regional Blood Center, Houston, Texas, USA.
Todd StrausMedical Services, The Community Blood Center, Appleton, Wisconsin, USA.
Patrick AlbrechtAssay Development, Roche Diagnostics International Ltd, Rotkreuz, Switzerland.
Lisa Lee PateClinical Development and Medical Affairs, Roche Molecular Systems, Inc., Pleasanton, California, USA.
Susan A GalelClinical Development and Medical Affairs, Roche Molecular Systems, Inc., Pleasanton, California, USA.
cobas Babesia IND study group
Materials Systems (United States) · USCanadian Blood Services · CAAmerican Red Cross · USEastern Iowa Community College · USInnovative Surface Technologies (United States) · USRoche (Switzerland) · CHTexas Medical Center · USVersiti Blood Center of Wisconsin · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman babesiosis is a zoonotic infection caused by an intraerythrocytic parasite. The highest incidence of babesiosis is in the United States, although cases have been reported in other parts of the world. Due to concerns of transfusion-transmitted babesiosis, the US Food and Drug Administration (FDA) recommended year-round regional testing for Babesia by nucleic acid testing or use of an FDA-approved device for pathogen reduction. A new molecular test, cobas Babesia (Roche Molecular Systems, Inc.), was evaluated for the detection of the four species that cause human disease, Babesia microti, Babesia duncani, Babesia divergens, and Babesia venatorum. STUDY DESIGN AND

methodsAnalytical performance was evaluated followed by clinical studies on whole blood samples from US blood donations collected in a special tube containing a chaotropic reagent that lyses the red cells and preserves nucleic acid. Sensitivity and specificity of the test in individual samples (individual donation testing [IDT]) and in pools of six donations were determined.

resultsBased on analytical studies, the claimed limit of detection of cobas Babesia for B. microti is 6.1 infected red blood cells (iRBC)/mL (95% confidence interval [CI]: 5.0, 7.9); B. duncani was 50.2 iRBC/mL (95% CI: 44.2, 58.8); B. divergens was 26.1 (95% CI: 22.3, 31.8); and B. venatorum was 40.0 iRBC/mL (95% CI: 34.1, 48.7). The clinical specificity for IDT was 99.999% (95% CI: 99.996, 100) and 100% (95% CI: 99.987, 100) for pools of six donations.

conclusioncobas Babesia enables donor screening for Babesia species with high sensitivity and specificity.

Indexed as

Blood DonorsBabesiaBabesia microtiBabesiosisDiagnostic Tests, RoutineDNA, ProtozoanDonor SelectionHumansRNA, ProtozoanSensitivity and SpecificityUnited StatesDNA, ProtozoanRNA, ProtozoanBabesiadonor blood screeningnucleic acid testing (NAT)

Identifiers

PMID34368968
PMCPMC9290686
OpenAlexW3190833155

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.