Implementation of Digital Image Analysis in Assessment of Ki67 Index in Breast Cancer.

The clinical utility of the proliferation marker Ki67 in breast cancer treatment and prognosis is an active area of research. Studies have suggested that differences in pre-analytic and analytic factors contribute to low analytical validity of the assay, with scoring methods accounting for a large proportion of this variability. Use of standard scoring methods is limited, in part due to the time intensive nature of such reporting protocols. Therefore, use of digital image analysis tools may help to both standardize reporting and improve workflow. In this study, digital image analysis was utilized to quantify Ki67 indices in 280 breast biopsy and resection specimens during routine clinical practice. The supervised Ki67 indices were then assessed for agreement with a manual count of 500 tumor cells. Agreement was excellent, with an intraclass correlation coefficient of 0.96 for the pathologist-supervised analysis. This study illustrates an example of a rapid, accurate workflow for implementation of digital image analysis in Ki67 scoring in breast cancer.

Transfusion-Transmitted Babesiosis.

Babesiosis is most commonly caused by Babesia microti and is transmitted via the bite of an infected Ixodes spp tick. However, Babesia is also transmitted via blood transfusion. In the United States, the first case of transfusion-transmitted babesiosis was recognized in 1979, and in recent years, the incidence has rapidly increased. Because most of the infected blood donors do not experience any symptoms, they pose a significant risk to the blood supply. Donor deferral for a history of babesiosis is currently performed but is ineffective. In March 2018, the FDA licensed a DNA PCR and antibody assay that were used in tandem in pivotal trials for screening blood donors for B microti; with other assays still being evaluated under investigational new drug protocols. Blood donation screening is essential to reducing the risk of transfusion-transmitted babesiosis, which is why blood centers collecting in geographic regions of highest risk have been testing since approximately 2010. Investigational NAT assays of higher sensitivity are pending FDA review. Further, in July 2018, the FDA issued a draft guidance for reducing the risk of transfusion-transmitted babesiosis. Release of the final guidance may be postponed until sensitivities and specificities of all current and potential strategies have been properly evaluated.

Evaluation of the BacterioScan 216Dx for Standalone Preculture Screen of Preserved Urine Specimens in a Clinical Setting.

BACKGROUND: The BacterioScan 216Dx laser microbial growth monitoring system was evaluated as an option for preurine culture screening of preserved urine specimens at an acute care medical center. METHODS: The BacterioScan 216Dx system performance characteristics and the economic impact (cost effectiveness) for the laboratory were assessed. Urinalysis performance compared to urine culture was assessed if urinalysis was ordered as part of the patient care set. RESULTS: When compared to urine culture, the BacterioScan had an overall performance with corresponding 95% confidence intervals of 76% (68-83) sensitivity, 84% (80-87) specificity, 55% (48-63) positive predictive value, and 93% (90-95) negative predictive value for 610 randomly selected preserved urine specimens. Urinalysis compared to urine culture overall performance was 59% (48-69) sensitivity, 87% (83-90) specificity, 53% (43-63) positive predictive value, 89% (86-92) negative predictive value for 414 urine specimens. CONCLUSIONS: While the system did improve the turnaround time to a negative report, adoption of the BacterioScan system would increase the reagent budget for laboratory urine culture by 2.34 times the current cost, potentially making BacterioScan prohibitive in a budget restricted environment. Additionally, performance when compared to traditional urine culture was less than acceptable for a diagnostic laboratory to use as a stand-alone urinary tract infection screen.