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

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.

Qualification of the Geenius HIV 1/2 supplemental assay for use in the HIV blood donation screening algorithm.

BACKGROUND: A single, simplified approach for human immunodeficiency virus (HIV)-1/HIV-2 antibody confirmation/differentiation is needed for the HIV blood donation supplemental algorithm used in the United States. A clinical evaluation of the Geenius assay was performed-the same assay used for HIV diagnostic confirmation/differentiation in the United States since 2014. STUDY DESIGN AND METHODS: Well-characterized unlinked donation samples classified as HIV negative, false positive, or confirmed positive were included in the study: 200 antibody-nonreactive, 200 HIV-1 immunofluorescence assay (IFA) confirmed-positive, and 100 antibody-screen false-positive donations, equally divided between serum and plasma. Samples were retrieved from a repository, relabeled, and tested by an immunochromatographic test (Geenius HIV 1/2 Supplemental Assay, Bio-Rad). Comparator testing involved parallel US Food and Drug Administration (FDA)-licensed HIV-1 IFA or HIV-2 enzyme immunoassay (EIA) supplemental testing for any sample missing those results as part of routine testing (otherwise test-of-record results were used). Samples with discordant results were further tested with a rapid test (Multispot HIV-1/HIV-2 Rapid Test, Bio-Rad) to provide final sample interpretations. Testing volume reductions with the Geenius were estimated from screening performed by the American Red Cross from September 2016 to April 2019. RESULTS: Clinical results were 100% sensitivity and specificity with an indeterminate rate of 4.0% to 5.0%. From 2016 to 2019, sole use of the Geenius would reduce testing complexity for 5265 antibody repeat-reactive donations including 95.7% (5028) false positives, eliminating approximately 5000 unnecessary tests. CONCLUSION: Geenius FDA licensure (August 26, 2019) adding the HIV-1/HIV-2 differentiation/confirmation donation supplemental claim will enable replacement of previously used FDA-licensed supplemental assays while maintaining comparable sensitivity, avoiding thousands of unnecessary HIV-1-IFA, western blot, and HIV-2-EIA tests.

Clopidogrel and 1-year freedom from amputation after endovascular lower extremity revascularization in the Medicare population.

OBJECTIVE: To evaluate freedom from amputation in patients identified utilizing clopidogrel following their lower extremity endovascular revascularization (LER). METHODS: Patients, 65 years of age and older, undergoing LER were identified from Medicare Provider Analysis and Review and Carrier files utilizing International Classification of Diseases diagnosis and Current Procedural Terminology codes. Postprocedural use of clopidogrel was identified using the National Drug Code directory. Outcomes were evaluated. RESULTS: A total of 14 353 patients were identified: 5697 (39.7%) with claudication, 1467 (10.2%) with rest pain, and 7189 (50.1%) with ulceration/tissue loss. In all, 5416 (37.7%) patients were identified using clopidogrel after LER. Overall, patients initiated on clopidogrel had lower amputation rates at 30 days (10.34% vs 14.09%; P < .0001), 90 days (14.05% vs 18.71%; P < .0001), and 1 year (19.68% vs 24.06%; P < .0001). CONCLUSION: Utilization of clopidogrel after LER was associated with lower rates of amputation, yet only 38% of the Medicare population was identified as using clopidogrel. Patients with ulceration and tissue loss benefited the most with significantly greater freedom from amputation and overall survival.

Use of Angio-Seal after iatrogenic trauma.

The clinical and intraoperative findings of an iatrogenic injury to a congenitally present right sided ascending aorta treated by deployment of a percutaneous closure device is reported. This is a first literature report of a biodegradable closure system being utililized to treat a puncture to the ascending arch.

Simplified management of low-energy projectile extraperitoneal rectal injuries.

INTRODUCTION: Since minimally invasive approach for fecal diversion in low-velocity extraperitoneal rectal injuries (EPRI) has a lower morbidity than open, and since computed tomography (CT) scan is helpful in ruling out concomitant intraperitoneal injuries (IPI), we utilized both modalities to simplify management of such injuries. METHODS: Retrospective review of stable patients with EPRI, treated with laparoscopic assisted diversion, after a CT scan, compared with patients with similar injuries that had a negative laparotomy and a colostomy. RESULTS: The laparoscopy group had a shorter length of stay (3 +/- 2 days versus 7 +/- 2 days), earlier return of bowel function (3 +/- 2 days versus 5 +/- 2 days) and fewer infectious complications. If the CT scan was negative for IPI, none were found on open exploration or laparoscopy. CONCLUSION: If IPI are ruled out with a preoperative CT scan, laparoscopy-assisted colostomy is safe and less morbid.

Screening laboratory and radiology panels for trauma patients have low utility and are not cost effective.

BACKGROUND: Routine laboratory and radiology panels as part of the initial evaluation of the trauma patient are prevalent practices. This is a study of utility and cost effectiveness of this practice. METHODS: During a 3-month period, trauma panels were analyzed for cost and impact on patient care in our institution. RESULTS: Four hundred ten consecutive patients had 3,982 studies (cost $417,839) performed of which 1,292 (cost $114,753) were abnormal and only 253 (cost $36,703) were clinically contributory. CONCLUSIONS: Routine panels are not useful or cost effective. Negative results contribute little to management. Selective and targeted studies should be indicated by the secondary survey, and may result in substantial cost savings ($1,500,000 per year at our institution).