Publications by authors named "Lee-Lewandrowski E"

Article Synopsis
  • The recently approved modified 2-tier testing (MTTT) algorithms for Lyme disease now utilize two enzyme immunoassays (EIAs) instead of an EIA followed by an immunoblot.
  • The Quidel Sofia Lyme fluorescent immunoassay, a rapid testing method, was evaluated as a first-tier test in comparison to the Zeus ELISA Borrelia test and confirmed with another EIA.
  • Results showed the Sofia test had a 91.4% positive agreement and a 100% negative agreement with the standard MTTT, indicating it performs well as a Lyme disease screening method.
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Article Synopsis
  • Early detection of tumors in cancer patients leads to better treatment outcomes for less advanced cancers.
  • Tumor-educated platelets (TEPs) can be used for cancer detection via RNA-based blood tests, identifying 18 different cancer types with high accuracy.
  • The thromboSeq test showed 99% specificity in asymptomatic controls, accurately detecting two-thirds of cancers in advanced stages, and helped determine the origin of tumors in over 80% of cases.
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Objectives: We evaluated trends in non-Lyme disease tick-borne disease (NLTBI) testing at a national reference laboratory.

Methods: Testing data performed at Quest Diagnostics during 2010 to 2016 were analyzed nationally and at the state level.

Results: Testing and positivity for most NLTBIs increased dramatically from 2010 through 2016 based on testing from a large reference laboratory.

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Objectives: We evaluated trends in Lyme disease (LD) testing at a national reference laboratory.

Methods: LD screening enzyme immunoassay and Western blot testing data performed at Quest Diagnostics during 2010 to 2016 were analyzed nationally and at the state level.

Results: Overall, 593,800 (11.

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Objectives: We evaluated changes in the testing menu, volume, and positivity rates for tick-borne illnesses in a New England medical center over an 11-year time frame.

Methods: Testing data were obtained by a retrospective review utilizing searchable data from a laboratory information system archive.

Results: Testing for tick-borne infections (TBI) increased 5.

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Blood-based liquid biopsies, including tumor-educated blood platelets (TEPs), have emerged as promising biomarker sources for non-invasive detection of cancer. Here we demonstrate that particle-swarm optimization (PSO)-enhanced algorithms enable efficient selection of RNA biomarker panels from platelet RNA-sequencing libraries (n = 779). This resulted in accurate TEP-based detection of early- and late-stage non-small-cell lung cancer (n = 518 late-stage validation cohort, accuracy, 88%; AUC, 0.

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Purpose: Ionized fraction (iMg) is the physiologically active form of magnesium (Mg); total Mg may not accurately reflect iMg status. Erroneously "low" Mg levels may result in unnecessary repetitive testing.

Materials And Methods: From 11/2015 to 01/2016, patients ordered for Mg from a pilot ICU also had iMg tested.

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Background: New onset atrial fibrillation (AF) in critically ill surgical patients is associated with significant morbidity and increased mortality. N-terminal pro-B type natriuretic peptide (NT-proBNP) is released by cardiomyocytes in response to stress and may predict AF development after surgery. We hypothesized that elevated NT-proBNP level at surgical intensive care unit (ICU) admission predicts AF development in a general surgical and trauma population.

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Background: We aimed to compare the diagnostic accuracy of the Alere Triage Cardio3 Tropinin I (TnI) assay (Alere, Inc., USA) and the PathFast cTnI-II (Mitsubishi Chemical Medience Corporation, Japan) against the central laboratory assay Singulex Erenna TnI assay (Singulex, USA).

Methods: Using the Markers in the Diagnosis of Acute Coronary Syndromes (MIDAS) study population, we evaluated the ability of three different assays to identify patients with acute myocardial infarction (AMI).

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Objectives: Point-of-care laboratory testing (POCT) offers reduced turnaround time and may promote improved operational efficiency. Few studies have been reported that document improvements from implementing POCT in primary care.

Methods: We measured metrics of practice efficiency in a primary care practice before and after implementation of POCT, including the total number of tests ordered, letters and phone calls to patients, and revisits due to abnormal test results.

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Objectives: The scope of activities performed by clinical laboratory directors is sometimes unfamiliar to other physicians or hospital administrators. Consequently, hospital leadership may undervalue the role and assume that many director level activities could be delegated to a professional manager. In this study, we sought to define the activities of academic laboratory directors, and to determine which activities require doctorate level medical or scientific expertise.

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This report describes the clinical evaluation of a novel fluorescent immunoassay (FIA), Sofia Influenza A+B FIA (Quidel, San Diego, CA), for the rapid detection and differentiation of influenza A and B viruses. A total of 2,047 subjects provided nasal swabs and nasopharyngeal swabs or aspirates. The overall sensitivity and specificity for influenza A virus vs virus culture were 94% and 95%, respectively, and for influenza B virus were 89% and 96%, respectively.

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Background: Measurement of creatinine and calculation of the estimated glomerular filtration rate (eGFR) are widely employed to identify patients with chronic kidney disease who are at risk for contrast induced acute kidney injury and nephrogenic systemic fibrosis. However, patients may present for radiologic studies without a recent creatinine/eGFR necessitating cancelation of the study or performance of the scan without contrast. Both of these approaches are suboptimal.

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Context: Previous studies evaluating point-of-care testing (POCT) for cardiac biomarkers did not use current recommendations for troponin cutoff values or recognize the recent universal definition of acute myocardial infarction. Traditionally, achieving optimal sensitivity for the detection of myocardial injury on initial presentation required combining cardiac troponin and/or creatine kinase isoenzyme MB with an early marker, usually myoglobin. In recent years, the performance of central laboratory combining cardiac troponin assays has improved significantly, potentially obviating the need for a multimarker panel to achieve optimum sensitivity.

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Introduction: There have been many reports describing individual POCT technologies but there are no recent studies describing the organizational scope and impact of a POCT program.

Methods: Our menu of POCT tests has increased to 26 and the test volume to 664,287 tests/year equivalent to 14.5% of the volume of the central core laboratory.

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Point-of-care testing (POCT) is usually more expensive on a unit-cost basis than testing performed in a central laboratory. It is difficult to manage POCT and to maintain regulatory compliance, especially in large institutions. However, some POCT technologies have improved patient outcomes (patient self-glucose monitoring in the home, tight glycemic control in intensive care settings) or hospital or emergency department operations (whole-blood cardiac-marker testing and D-dimer testing in emergency departments).

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Overcrowding and prolonged patient length-of-stay (LOS) in emergency departments (EDs) are growing problems. We evaluated the impact of implementing a rapid whole blood quantitative D-dimer test (Biosite Triage, Biosite Diagnostics, San Diego, CA) in our ED satellite laboratory on 252 patients before vs 211 patients after implementation. All patients also underwent testing with the existing central laboratory method (VIDAS D-dimer, bioMérieux, Durham, NC).

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Background: Fecal occult blood testing (FOBT) is one method to screen for colorectal cancer and to assess for gastrointestinal bleeding in hospitalized patients. Differences in the analytical sensitivity among various methods may have significant clinical repercussions.

Methods: We evaluated the analytical performance of 5 different FOBT methods (standard guaiac-based method and four immunochemical methods) using patient samples and spiked stool specimens.

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We measured analytes in collapsed Boston Marathon runners to compare with changes in asymptomatic runners. Of collapsed runners at the 2007 marathon, 18.2% had a measurable cardiac troponin T (cTnT) value with a mean postrace level of 0.

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We evaluated the impact of implementing a point-of-care (POC) rapid urine test panel for drugs of abuse on turnaround time (TAT), emergency department length of stay (LOS), and laboratory test utilization patterns. The mean TAT from sample collection to results reporting decreased by 69.4%, from 108 to 33 minutes, the mean LOS from 11.

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Background: NT-proBNP measurements aid in the evaluation of patients with suspected heart failure (HF) and may facilitate risk stratification in patients with HF and acute coronary syndrome (ACS). Point-of-care (POC) assays may provide more timely results and potentially improve patient outcomes.

Methods: We evaluated the analytical performance of the Response Biomedical Corporation whole blood RAMP amino-terminal pro-B type natriuretic peptide (NT-proBNP) POC assay compared to the Roche Elecsys proBNP (NT-proBNP) assay.

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Context: In clinical trials, N-terminal pro-brain natriuretic peptide (NT-proBNP) testing has been shown to be valuable for diagnosis and triage of patients with acute decompensated heart failure. It is not yet clear what benefits might be expected from the initiation of NT-proBNP testing in an everyday clinical setting.

Objective: To determine the effects of NT-proBNP testing on hospital length of stay as well as on 60-day morbidity and mortality in patients with acute decompensated heart failure before and after the test was implemented in the clinical laboratory.

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Purpose: Exercise-associated hyponatremia (EAH), as defined by a blood sodium concentration [Na+] less than 135 mmol/L, may lead to hypotonic encephalopathy with fatal cerebral edema. Understanding the pathogenetic role of antidiuresis may lead to improved strategies for prevention and treatment.

Methods: Normonatremic marathon runners were tested pre- and post-race for creatine kinase, interleukin-6, cortisol, prolactin, and arginine vasopressin.

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Background: Combining testing for natriuretic peptides [amino-terminal pro-brain natriuretic peptide (NT-proBNP) and brain natriuretic peptide (BNP)] and cardiac troponin T (cTnT) may help predict mortality in patients with acute heart failure (HF).

Methods: We studied 209 patients with acute HF at an urban academic center and used ROC curves and multivariate analyses to examine the relationship of outcome to natriuretic peptide and cTnT concentrations at presentation.

Results: Higher concentrations of natriuretic peptides and cTnT at presentation were predictors of death at 60 days and 1 year (P <0.

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Background: Amino-terminal pro-brain natriuretic peptide (NT-proBNP) testing is useful for diagnosis or exclusion of heart failure (HF) in dyspneic patients. Atrial fibrillation (AF) may cause dyspnea in the absence of acute HF and may also affect plasma levels of NT-proBNP.

Methods: We prospectively enrolled 599 patients presenting with dyspnea to the emergency department and obtained a blood sample for NT-proBNP measurement.

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