Jean Stanley1, Susan L Stramer2, Yasuko Erickson3, Julie Cruz4, Jed Gorlin5, Mark Janzen6, Susan N Rossmann7, Todd Straus8, Patrick Albrecht9, Lisa Lee Pate1, Susan A Galel1. 1. Clinical Development and Medical Affairs, Roche Molecular Systems, Inc., Pleasanton, California, USA. 2. Scientific Services, American Red Cross, Gaithersburg, Maryland, USA. 3. Medical Affairs, ImpactLife, Davenport, Iowa, USA. 4. Medical Science Institute, Versiti Blood Center, Indianapolis, Indiana, USA. 5. Physician Services, Innovative Blood Resources, St. Paul, Minnesota, USA. 6. Laboratory Services, Innovative Blood Resources, St. Paul, Minnesota, USA. 7. Medical Services, Gulf Coast Regional Blood Center, Houston, Texas, USA. 8. Medical Services, The Community Blood Center, Appleton, Wisconsin, USA. 9. Assay Development, Roche Diagnostics International Ltd, Rotkreuz, Switzerland.
Abstract
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.
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.
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Authors: Jean Stanley; Susan L Stramer; Yasuko Erickson; Julie Cruz; Jed Gorlin; Mark Janzen; Susan N Rossmann; Todd Straus; Patrick Albrecht; Lisa Lee Pate; Susan A Galel Journal: Transfusion Date: 2021-08-08 Impact factor: 3.337
Authors: Jean Stanley; Susan L Stramer; Yasuko Erickson; Julie Cruz; Jed Gorlin; Mark Janzen; Susan N Rossmann; Todd Straus; Patrick Albrecht; Lisa Lee Pate; Susan A Galel Journal: Transfusion Date: 2021-08-08 Impact factor: 3.337