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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.

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