Evaluation of Lyme serologic quantitative test indexes: High first-tier test index values predict positive second-tier result in standard and modified 2-tier Lyme testing algorithms.

Objectives: In this study, we evaluated the potential utility of reporting a quantitative Lyme serologic test index to improve the utility of results from first-tier Lyme assays.

Methods: Serum from consecutive samples sent to our laboratory for Lyme testing were tested on 2 commercial first-tier Lyme assays and evaluated to determine the probability of second-tier confirmation based on the serologic index value.

Results: For both assays, we identified an index value above which 100% of samples confirmed on second-tier testing using both standard and modified 2-tier testing algorithms.

Evaluation of the rapid Quidel Sofia Lyme fluorescent immunoassay as a first-tier test in a modified 2-tier testing algorithm for Lyme disease: A comparison with the Zeus ELISA Borrelia VlsE1/pepC10 lgG/IgM assay followed by the Zeus monovalent IgM/IgG confirmatory assay.

Objectives: Recently modified 2-tier testing (MTTT) algorithms using 2 enzyme immunoassays (EIAs) as opposed to an EIA followed by immunoblot have been approved by the US Food and Drug Administration (FDA) for the screening and confirmation of Lyme disease. The Quidel Sofia Lyme fluorescent immunoassay is a rapid lateral-flow method that can be performed in real time, permitting on-demand testing. We evaluated the performance of the Sofia assay as a first-tier test in an MTTT algorithm.

Measurement of High Sensitivity Troponin T in Patients with Early Stage Lyme Disease: Preliminary Evidence for Possible Subclinical Cardiac Involvement.

Objective: In patients with early Lyme disease (ELD), cardiac involvement is known to occur in approximately 1% of patients. We measured high-sensitivity troponin T (hsTnT) in patients with early Lyme disease to evaluate the possibility of subclinical cardiac involvement.

Methods: We measured hsTnT in 41 patients with well characterized ELD.

Description of a point-of-care testing program in a large urban academic medical center: Technologies, management and program cost.

Background: Point-of-care testing (POCT) is an important component of hospital-based and ambulatory laboratory testing. Despite its importance, there is relatively little in the peer reviewed literature describing the details of successful POCT programs.

Methods: Administrative records and test volumes from the Massachusetts General Hospital were compiled using POCT middleware (Telcor) and the hospital information system (Epic).

Laboratory Blood-Based Testing for Non-Lyme Disease Tick-Borne Infections at a National Reference Laboratory.

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.

Laboratory Blood-Based Testing for Lyme Disease at a National Reference Laboratory.

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.

Laboratory Testing for Tick-Borne Infections in a Large Northeastern Academic Medical Center: An 11-Year Experience.

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.

Implementation of point-of-care testing in a general internal medicine practice: A confirmation study.

Background: In a previous study we reported on the impact of point-of-care testing (POCT) on practice efficiency in an academic primary care practice that was established to develop new models of care delivery. Here we report a follow-on confirmation study in a more typical primary care practice in the community.

Methods: In this observational study with a retrospective comparison analysis we measured metrics of practice efficiency on two patient cohorts: those that did not receive POCT and those that did.

Swarm Intelligence-Enhanced Detection of Non-Small-Cell Lung Cancer Using Tumor-Educated Platelets.

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.

Total and ionized magnesium testing in the surgical intensive care unit - Opportunities for improved laboratory and pharmacy utilization.

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.

Elevated admission N-terminal pro-brain natriuretic peptide level predicts the development of atrial fibrillation in general surgical intensive care unit patients.

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.

Can a Point-of-Care Troponin I Assay be as Good as a Central Laboratory Assay? A MIDAS Investigation.

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).

Implementation of point-of-care testing in an ambulatory practice of an academic medical center.

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.

The practice of clinical pathology: a quantitative description of laboratory director activities at a large academic medical center.

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.

Patient satisfaction with point-of-care laboratory testing: report of a quality improvement program in an ambulatory practice of an academic medical center.

Background: Point-of-care laboratory testing (POCT) offers reduced turnaround time and may facilitate medical decision-making and improve clinical operations. However, there is very little published data concerning the impact of POCT on patient satisfaction.

Methods: We implemented POCT for hemoglobin A1c, lipid panel and comprehensive metabolic panel in a primary care practice and monitored patient satisfaction with on-site testing using an anonymous survey.

Detection of influenza A and B viruses with the Sofia analyzer: a novel, rapid immunofluorescence-based in vitro diagnostic device.

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.

Evaluation of rapid point-of-care creatinine testing in the radiology service of a large academic medical center: impact on clinical operations and patient disposition.

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.

Clinical evaluation of the i-STAT kaolin activated clotting time (ACT) test in different clinical settings in a large academic urban medical center: comparison with the Medtronic ACT Plus.

Historically, it has been difficult for hospitals to change methods for activated clotting time (ACT) testing because of differences in ACT values obtained with different instruments, wide differences in target ranges used in different procedures, and the difficulty of performing crossover studies at the bedside in critical care situations. There are limited published data comparing the i-STAT (Abbott Point of Care, Princeton, NJ) kaolin ACT with the Medtronic ACT Plus (Medtronic, Minneapolis, MN). The i-STAT system can perform ACT testing in addition to testing of a number of critical care analytes and may offer potential advantages over other ACT analyzers.

Evaluation of first-draw whole blood, point-of-care cardiac markers in the context of the universal definition of myocardial infarction: a comparison of a multimarker panel to troponin alone and to testing in the central laboratory.

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.

Point of care testing in a large urban academic medical center: evolving test menu and clinical applications.

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.

Perspectives on cost and outcomes for point-of-care testing.

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).

Implementation of a rapid whole blood D-dimer test in the emergency department of an urban academic medical center: impact on ED length of stay and ancillary test utilization.

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).

Comparison of conventional guaiac to four immunochemical methods for fecal occult blood testing: implications for clinical practice in hospital and outpatient settings.

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.