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Detection of Babesia RNA and DNA in whole blood samples from US blood donations
Author(s) -
Stanley Jean,
Stramer Susan L.,
Erickson Yasuko,
Cruz Julie,
Gorlin Jed,
Janzen Mark,
Rossmann Susan N.,
Straus Todd,
Albrecht Patrick,
Pate Lisa Lee,
Galel Susan A.
Publication year - 2021
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.16617
Subject(s) - babesia , babesiosis , virology , biology , blood donations , nucleic acid , babesia bigemina , parasite hosting , medicine , human immunodeficiency virus (hiv) , biochemistry , world wide web , computer science
Background Human 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 methods Analytical 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. Results Based 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. Conclusion cobas Babesia enables donor screening for Babesia species with high sensitivity and specificity.