The clinical effect of glucose meter selection upon the detection of neonatal hypoglycemia.

Neonatal hypoglycemia is a common, transitional metabolic state that may lead to poor neurodevelopmental outcomes if unrecognized or managed inadequately. Given its frequency of presentation and immense clinical significance, a myriad of clinical practice guidelines have been published outlining appropriate screening, diagnosis, and treatment principles-many endorsing the use of glucose point-of-care testing (POCT). Unfortunately, the well-intended 'march' toward POCT, with bedside glucose meters as screening devices in the NICU, has resulted in unintended consequences with critical implications: a lack of international traceability to the 'gold' standard glucose method by POCT devices, under-recognition of POCT limitations, and a reliance upon a technology primarily driven to detect hyperglycemia in the adult population as opposed to neonatal hypoglycemia.

Rainbow of colors: Inspissated bile syndrome secondary to hemolytic disease of the newborn and concomitant serum dynamics.

The recent clinical experience with hemolytic disease of the newborn and its post-icteric sequelae is limited among high-income countries because of nearly over four decades of effective prevention care. In this case, we will discuss the sequelae of a baby born with hemolytic disease of the newborn to an Rh negative mother with no prenatal care from remote northern Saskatchewan. Inspissated bile syndrome is a rare but serious complication of hemolytic disease of the newborn.

Side-Effects of COVID-19 on Patient Care: An INR Story.

Background: Numerous studies have documented reduced access to patient care due to the COVID-19 pandemic, including access to diagnostic or screening tests, prescription medications, and treatment for an ongoing condition. In the context of clinical management for venous thromboembolism, this could result in suboptimal therapy with warfarin. We aimed to determine the impact of the pandemic on utilization of International Normalized Ratio (INR) testing and the percentage of high and low results.

N-Acetylcysteine Interference with a Glucose Dehydrogenase Linked Glucose Meter.

Background: Our objective was to determine the effect of therapeutic concentrations of N-acetylcysteine, following intravenous infusion, on the measurement of blood glucose using a Roche Diagnostics glucose dehydrogenase-linked glucose meter compared to hospital laboratory methods.

Methods: N-acetylcysteine was added to aliquots of blood, with glucose promptly measured by the glucose meter, blood gas analyzer (glucose oxidase comparative method) and following centrifugation, plasma glucose measured with a hexokinase spectrophotometric comparative method. Glucose results were evaluated with linear regression and Bland Altman plots.

COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

Background: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients.

Methods: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios.

Providing Inclusive Care for Transgender Patients: Capturing Sex and Gender in the Electronic Medical Record.

Background: Providing a positive patient experience for transgender individuals includes making the best care decisions and providing an inclusive care environment in which individuals are welcomed and respected. Over the past decades, introduction of electronic medical record (EMR) systems into healthcare has improved quality of care and patient outcomes through improved communications among care providers and patients and reduced medical errors. Promoting the highest standards of care for the transgender populations requires collecting and documenting detailed information about patient identity, including sex and gender information in both the EMR and laboratory information system (LIS).

Estimated Risk for Insulin Dose Error Among Hospital Patients Due to Glucose Meter Hematocrit Bias in 2020.

Context.—: Glycemic control requires accurate blood glucose testing. The extent of hematocrit interference is difficult to assess to assure quality patient care.

Chemotherapy readiness in pediatric oncology: Assessing an automated method to measure urine specific gravity.

As part of the evaluation for chemotherapy readiness, urine specific gravity is measured to assess the patient's overall hydration status. Depending on the accuracy of the methods used, patients may be adversely affected by having their chemotherapy delayed or prematurely started. To evaluate the diagnostic accuracy of a new automated urine dipstick readout device (Clinitek), we tested 196 consecutive urine samples for urine specific gravity and compared them with the practical gold standard, a urine refractometer.

Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models.

Background: The objective of this study was to estimate the combinations of total bias and total imprecision required for devices to meet the Food and Drug Administration (FDA) specifications using Monte Carlo simulation rather than collection and analysis of experimental data.

Methods: A model Gaussian distribution of true-glucose values was altered by adding bias and imprecision to create measured-glucose values affected by analytic error. The fraction of measured-glucose values that met the 2018 FDA criteria for blood glucose monitoring system (BGMS) or self-monitoring blood glucose (SMBG) devices was determined as a function of bias and imprecision.

A Simulation Study to Assess the Effect of Analytic Error on Neonatal Glucose Measurements Using the Canadian Pediatric Society Position Statement Action Thresholds.

Background: The Canadian Pediatric Society (CPS) has endorsed an algorithm for the screening and immediate management of babies at risk of neonatal hypoglycemia that provides time-dependent glucose concentration action thresholds. The objective of this study was to evaluate the impact of glucose analytic error (bias and imprecision) on the misclassification of glucose meter results from a neonatal intensive care unit (NICU) using the CPS guidelines.

Methods: A simulation dataset of true glucose values ( = 100 000) was derived by finite mixture model analysis of NICU glucose data ( = 23 749).

Analytical Concordance of Diverse Point-of-Care and Central Laboratory Troponin I Assays.

Background: Cardiac troponin I (cTnI) 99th percentile cutoffs, used in the diagnosis of acute myocardial infarction, are not standardized across cTnI assays. We compared 3 point-of-care (POC) and 1 central laboratory contemporary cTnI assays against the Abbott high-sensitivity (hs) cTnI to evaluate the analytical concordance and the feasibility of using a single cutoff value for all assays.

Methods: Fresh blood samples collected from 102 inpatients in the coronary care unit were measured on central laboratory instruments (Beckman Coulter DxI AccuTnI+3 TnI, Abbott Architect hs-TnI) and cTnI POC analyzers (Alere Triage Troponin I, Radiometer AQT90, Abbott i-STAT).

An insulin-dose error assessment grid: A new tool to evaluate glucose meter performance.

Objective: To develop a tool to assess the clinical accuracy of glucose meter performance using an insulin dosing protocol to assess the frequency and extent of error in insulin dose categories.

Methods: Retrospective comparison of 1815 glucose meter and central laboratory glucose results obtained from 1698 critically ill patients was conducted using the Parkes error grid, Surveillance error grid and an insulin dose error assessment grid with a sliding scale insulin dosing protocol used to manage critically ill patients.

Results: Parkes error grid and Surveillance error grid analyses indicated little risk conferred with the glucose meter results.

Comparative evaluation of neonatal bilirubin using Radiometer whole blood co-oximetry and plasma bilirubin methods from Roche Diagnostics and Ortho Clinical Diagnostics.

Background: Clinically significant variation has been reported within and between plasma and whole blood total bilirubin methods used to identify neonates for whom clinical intervention for hyperbilirubinemia may be required.

Objective: To evaluate total bilirubin measurements between the Radiometer whole blood co-oximeter and plasma bilirubin methods from Roche Diagnostics and Ortho Clinical Diagnostics using neonatal specimens.

Methods: Total bilirubin levels were analyzed by whole blood co-oximetry (Radiometer® ABL90).

Application of a Simulation Model to Estimate Treatment Error and Clinical Risk Derived from Point-of-Care International Normalized Ratio Device Analytic Performance.

Background: In 2016, the Food and Drug Administration (FDA) proposed to enhance performance expectations for point-of-care testing (POCT) international normalized ratio (INR) devices relative to International Organization for Standardization (ISO) 17593:2007. The objective of the study was to estimate the frequency of warfarin dosing errors associated with a central laboratory INR method, a POCT INR method, and the proposed FDA performance goals.

Methods: A data set of INR results (n = 51912) from adult patients with INR ≤4 was used to assess the influence of adding assay imprecision and bias on warfarin dose decisions.

Limitations and opportunities of whole blood bilirubin measurements by GEM premier 4000®.

Background: Neonatal hyperbilirubinemia has traditionally been screened by either total serum bilirubin or transcutaneous bilirubin. Whole blood bilirubin (TwB) by the GEM Premier 4000® blood gas analyzer (GEM) is a relatively new technology and it provides fast bilirubin results with a small sample volume and can measure co-oximetry and other analytes. Our clinical study was to evaluate the reliability of TwB measured by the GEM and identify analytical and clinical factors that may contribute to possible bias.

Normalization Time of Celiac Serology in Children on a Gluten-free Diet.

Objectives: Response to a gluten-free diet (GFD) in children with celiac disease is determined by symptom resolution and normalization of serology. We evaluated the rate of normalization of the transglutaminase (TTG) and antiendomysial (EMA) for children on a GFD after diagnosis.

Methods: Celiac serologies were obtained over 3.

Bedside Glucose Monitoring-Is it Safe? A New, Regulatory-Compliant Risk Assessment Evaluation Protocol in Critically Ill Patient Care Settings.

Objectives: New data have emerged from ambulatory and acute care settings about adverse patient events, including death, attributable to erroneous blood glucose meter measurements and leading to questions over their use in critically ill patients. The U.S.

Simulation Models of Misclassification Error for Single Thresholds of High-Sensitivity Cardiac Troponin I Due to Assay Bias and Imprecision.

Background: Clinical outcome studies for cardiac troponins (cTn) are expensive and difficult to design owing to variation in patients, in the assays, and in the incidence of different types of myocardial infarction (MI). To overcome these difficulties, simulation models were used to estimate the rate of misclassification error for MI and risk prediction resulting from assay bias and imprecision.

Methods: Finite mixture analysis of Abbott high-sensitivity cTnI (hs-cTnI) results at time 0 h in patients presenting early with acute coronary syndrome (ACS) symptoms to the emergency department (ED) [n = 145, Reducing the Time Interval for Identifying New Guideline (RING) study] allowed derivation of a simulation data set (n = 10000).

The clinical impact of implementing the Roche® bilirubin total Gen.3 method on neonate phototherapy.

Objective: To predict the impact of implementing the Roche® Gen.3 bilirubin total method on the number of bilirubin results that would trigger phototherapy using the phototherapy nomogram published in the Canadian Paediatric Society (CPS) Guidelines for Treatment of Hyperbilirubinemia.

Design And Methods: BILTS method results (N=563) were obtained on the Roche® C501 analyzer and the corresponding Bilirubin Total Gen.