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Point-of-care (POC) tests are in high demand in order to facilitate rapid care decisions for patients suspected of SARS-CoV-2. We conducted a clinical validation study of the Cue Health POC nucleic acid amplification test (NAAT) using the Cue lower nasal swab, compared to a reference NAAT using standard nasopharyngeal swab, in 292 symptomatic and asymptomatic outpatients for SARS-CoV-2 detection in a community drive through collection setting. Positive percent agreement between Cue COVID-19 and reference SARS-CoV-2 test was 91.7% (22 of 24); or 95.7% (22 of 23) when one patient with no tie-breaker method was excluded. Negative percent agreement was 98.4% (239 of 243), and there were 25 (8.6%) invalid or canceled results. The Cue COVID-19 test demonstrated very good positive and negative percent agreement with central laboratory tests and will be useful in settings where accurate POC testing is needed to facilitate management of patients suspected of COVID-19., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) are common laboratory assays used as markers of inflammation. ESR suffers from higher false positive and false negative rates than CRP. To that end, the American Board of Internal Medicine's (ABIM's) Choosing Wisely campaign has recommended against ESR testing for those with undiagnosed conditions in favor of CRP testing. This study describes the impact of a computerized provider order entry (CPOE) decision support rule against ESR/CRP co-ordering within a community health system that predates the ABIM's Choosing Wisely national guidance. To demonstrate the potential impact of such a CPOE rule within other healthcare settings, ESR/CRP ordering data from a multi-site tertiary care practice and from the commercially insured population in the OptumLabs® Data Warehouse (OLDW) were analyzed and the relative reduction in ESR/CRP co-ordering achieved within the community health system was projected onto these populations., Materials and Methods: ESR and/or CRP orders from a community health system were assessed from 2012 to 2016. Co-ordering and test concordance rates between ESR and CRP were compared before and after CPOE decision support rule launch. Similarly, ESR/CRP co-ordering across three tertiary care sites from 2015 to 2016 and the OLDW from 2009 to 2013 were assessed and the co-ordering rate reduction achieved in the community health system was mathematically projected onto these populations. Estimated payer savings from the rule's effect were calculated within each population using Medicare reimbursement rates., Results: The CPOE decision support rule realized an unadjusted 42% relative rate reduction in ESR/CRP co-ordering within the community health system yielding an annual payer savings of $15,000 with a modest increase in ESR/CRP concordance rates. Projecting a 40% relative reduction in ESR/CRP co-ordering rates from a similarly effective CPOE rule, annual payer cost reductions exceeding $100,000 within a multi-site tertiary care setting and $1,000,000 within the OLDW would be expected., Conclusion: ESR/CRP co-ordering represents an opportunity to eliminate testing waste and reduce payer costs. A CPOE decision support rule stably reduces ESR/CRP co-ordering rates. Similar results may occur as one component of new commercially available decision support platforms., (Copyright © 2019 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)

Background: Ehrlichiosis is a clinically important, emerging zoonosis. Only Ehrlichia chaffeensis and E. ewingii have been thought to cause ehrlichiosis in humans in the United States. Patients with suspected ehrlichiosis routinely undergo testing to ensure proper diagnosis and to ascertain the cause., Methods: We used molecular methods, culturing, and serologic testing to diagnose and ascertain the cause of cases of ehrlichiosis., Results: On testing, four cases of ehrlichiosis in Minnesota or Wisconsin were found not to be from E. chaffeensis or E. ewingii and instead to be caused by a newly discovered ehrlichia species. All patients had fever, malaise, headache, and lymphopenia; three had thrombocytopenia; and two had elevated liver-enzyme levels. All recovered after receiving doxycycline treatment. At least 17 of 697 Ixodes scapularis ticks collected in Minnesota or Wisconsin were positive for the same ehrlichia species on polymerase-chain-reaction testing. Genetic analyses revealed that this new ehrlichia species is closely related to E. muris., Conclusions: We report a new ehrlichia species in Minnesota and Wisconsin and provide supportive clinical, epidemiologic, culture, DNA-sequence, and vector data. Physicians need to be aware of this newly discovered close relative of E. muris to ensure appropriate testing, treatment, and regional surveillance. (Funded by the National Institutes of Health and the Centers for Disease Control and Prevention.).

Context: Endoscopic brush cytology is a valuable technique for the diagnosis of pancreatobiliary malignancy. Despite its widespread use, the sensitivity of this method has been reported as approximately 50%. The specificity is usually higher than 95%. Few reports have systematically analyzed the reasons for this relatively low sensitivity., Objectives: To determine the rate and reasons for false-negative diagnoses in endoscopic brushing cytology of biliary and pancreatic ducts based on the results of sensitivity, specificity, accuracy, and positive and negative predictive values., Design: Retrospective analysis of laboratory data and slide review of false-negative cases., Setting: Two tertiary care state university hospitals., Patients: A total of 183 pancreatobiliary brushing specimens obtained from patients undergoing endoscopic retrograde cholangiopancreatography for biliary or pancreatic duct disease for a 4- to 5-year period., Intervention: Endoscopic retrograde cholangiopancreatography brushings., Main Outcome Measures: Determination of sensitivity, specificity, accuracy, and positive and negative predictive values. Analysis of false-negative results., Results: The sensitivity, specificity, accuracy, and positive and negative predictive values, overall, were 48%, 98%, 79%, 92%, and 76%, respectively. Sampling error was a major cause of false-negative diagnoses (67%), followed by interpretive (17%) and technical errors (17%)., Conclusions: Improvements in sensitivity and diagnostic accuracy for cancer of the pancreatobiliary tract can be achieved by optimizing slide preparatory techniques. Also, enhancement of the cytologist's diagnostic skills enables the identification of the morphologic features of premalignant lesions. Repeat brushings are indicated for suspicious or negative results not consistent with the clinical or radiologic findings.