The variability of measured and calculated low-density lipoprotein (LDL) cholesterol in statin-treated diabetes patients.

Background: The Sampson-NIH and Martin-Hopkins low-density lipoprotein cholesterol (LDL-C) equations are advocated as being superior to the Friedewald calculation. However, their mathematical complexity means they may have different biological and analytical variation when tracking LDL-C in the same patient. This study has established the biological variation (BV) of calculated and directly measured LDL-C (dLDL-C) in patients taking equivalent doses of a long (atorvastatin) and short (simvastatin) half-life statin.

Effects of Consuming Fermented Fish (Surströmming) on the Fecal Microflora in Healthy Individuals.

, a Swedish fermented fish, loved by some and avoided by others, occurs in many reports on improved or cured gastrointestinal problems even by a single meal. We tested the hypothesis that the microbes of the fermented food might have a potency to modify the gut microbiome. Two groups of voluntary participants (11 male, 8 female; aged 20-80 years) were exposed to a single meal containing the fish.

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review.

Background: Bone marrow aspirate concentrate (BMAC) has emerged as a therapeutic option for symptomatic knee osteoarthritis (OA).

Purpose: To systematically review the literature to evaluate the efficacy of isolated BMAC injection in the treatment of OA of the knee joint.

Study Design: Systematic review; Level of evidence, 4.

Measurement repeatability profiles of eight frequently requested measurands in clinical chemistry determined by duplicate measurements of patient samples.

Measurement uncertainties in clinical chemistry are commonly regarded as heteroscedastic - having a constant relative standard deviation irrespective of the concentration of the measurand. The uncertainty is usually determined at two concentrations using stabilized control materials and assumed to represent the analytical goal. The purpose of the present study was to use duplicates of unselected patient samples to calculate the absolute and relative repeatability component of the intra-laboratory measurement uncertainty from duplicates, using the Dahlberg formula and analysis of variance components.

Repeatability imprecision from analysis of duplicates of patient samples and control materials.

Measurement imprecision is usually calculated from measurement results of the same stabilized control material(s) obtained over time, and is therefore, principally, only valid at the concentration(s) of the selected control material(s). The resulting uncertainty has been obtained under reproducibility conditions and corresponds to the conventional analytical goals. Furthermore, the commutability of the control materials used determines whether the imprecision calculated from the control materials reflects the imprecision of measuring patient samples.

Measurement Uncertainty Impacts Diagnosis of Diabetes Mellitus: Reliable Minimal Difference of Plasma Glucose Results.

Introduction: The diagnosis of diabetes mellitus is based on suitable cut-off values of specific biomarkers, such as the concentration of glucose in plasma. The German Diabetes Association has very recently published a clinical practice guideline on the definition, classification and diagnosis of diabetes mellitus that recommends measurements of plasma glucose concentration have an imprecision defined as a minimal difference (MD) of at a fasting plasma glucose concentration of 7.0 mmol/L.

An experimental study of methods for the analysis of variance components in the inference of laboratory information.

Measurement uncertainty (MU) can be estimated and calculated by different procedures, representing different aspects and intended use. It is appropriate to distinguish between uncertainty determined under repeatability and reproducibility conditions, and to distinguish causes of variation using analysis of variance components. The intra-laboratory MU is frequently determined by repeated measurements of control material(s) of one or several concentrations during a prolonged period of time.

Impact of Glucose Measuring Systems and Sample Type on Diagnosis Rates of Diabetes Mellitus.

Introduction: The use of glucose point-of-care testing (POCT) devices for the diagnosis of diabetes mellitus (DM) is an ongoing controversy. In patient management, glucose concentrations are determined by POCT and core laboratory glucose methods, and the values are commonly compared even though the samples collected are different, namely, capillary whole blood and venous plasma. In individual patients it is difficult to distinguish between factors that can influence the results, such as sample type and measuring procedure.

Age-adjusted D-dimer cut-off leads to more efficient diagnosis of venous thromboembolism in the emergency department: a comparison of four assays.

Unlabelled: Essentials Age-adjusted D-dimer cut-offs decrease the false positives in the elderly. Four D-dimer assays were compared in venous thromboembolism outpatients in an emergency ward. Age-adjusted cut-off resulted in improved specificity with maintained sensitivity for all assays.

Bayes' theorem, the ROC diagram and reference values: Definition and use in clinical diagnosis.

Medicine is diagnosis, treatment and care. To diagnose is to consider the probability of the cause of discomfort experienced by the patient. The physician may face many options and all decisions are liable to uncertainty to some extent.

The 99th percentile and imprecision of point-of-care cardiac troponin I in comparison to central laboratory tests in a large reference population.

Objectives: Determination of cardiac troponin (cTn) is central in the emergency department (ED) for the diagnosis of myocardial infarction. In view of adverse effects of long waiting time on patient outcome, implementation of point-of-care-testing (POCT) is suggested if the turn-around-time is longer than 60min. The present study aimed to determine the 99th percentile and imprecision of two POCT in a healthy population measuring cTnI and cTnT and compare these analytical characteristics against three central laboratory test (CLT) for cTnI.

The use of error and uncertainty methods in the medical laboratory.

Error methods - compared with uncertainty methods - offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine. However, uncertainty methods are preferred in other fields of science as reflected by the guide to the expression of uncertainty in measurement. When laboratory results are used for supporting medical diagnoses, the total uncertainty consists only partially of analytical variation.

Analytical robustness of nine common assays: frequency of outliers and extreme differences identified by a large number of duplicate measurements.

Introduction: Duplicate measurements can be used to describe the performance and analytical robustness of assays and to identify outliers. We performed about 235,000 duplicate measurements of nine routinely measured quantities and evaluated the observed differences between the replicates to develop new markers for analytical performance and robustness.

Materials And Methods: Catalytic activity concentrations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and concentrations of calcium, cholesterol, creatinine, C-reactive protein (CRP), lactate, triglycerides and thyroid-stimulating hormone (TSH) in 237,261 patient plasma samples were measured in replicates using routine methods.

Validation of an enzyme-linked immunosorbent assay for the quantification of citrullinated histone H3 as a marker for neutrophil extracellular traps in human plasma.

There is an emerging interest in the diverse functions of neutrophil extracellular traps (NETs) in a variety of disease settings. However, data on circulating NETs rely largely upon surrogate NET markers such as cell-free DNA, nucleosomes, and NET-associated enzymes. Citrullination of histone H3 by peptidyl arginine deiminase 4 (PAD4) is central for NET formation, and citrullinated histone H3 (H3Cit) is considered a NET-specific biomarker.

A practical tool for monitoring the performance of measuring systems in a laboratory network: report of an ACB Working Group.

Background A logical consequence of the introduction of robotics and high-capacity analysers has seen a consolidation to larger units. This requires new structures and quality systems to ensure that laboratories deliver consistent and comparable results. Methods A spreadsheet program was designed to accommodate results from up to 12 different instruments/laboratories and present IQC data, i.

Extending laboratory automation to the wards: effect of an innovative pneumatic tube system on diagnostic samples and transport time.

Background: The innovative pneumatic tube system (iPTS) transports one sample at a time without the use of cartridges and allows rapid sending of samples directly into the bulk loader of a laboratory automation system (LAS). We investigated effects of the iPTS on samples and turn-around time (TAT).

Methods: During transport, a mini data logger recorded the accelerations in three dimensions and reported them in arbitrary area under the curve (AUC) units.

Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry.

The performance of all measurement procedures used in routine clinical laboratories shall be verified; a minimum is to verify the precision and trueness of the results. This is well established and adequate recommendations and procedures are available. Conveying this information in a form that is adequate and understandable for the practical end-user in the health care sector is still a much debated issue.

Discrepant post filter ionized calcium concentrations by common blood gas analyzers in CRRT using regional citrate anticoagulation.

Introduction: Ionized calcium (iCa) concentration is often used in critical care and measured using blood gas analyzers at the point of care. Controlling and adjusting regional citrate anticoagulation (RCA) for continuous renal replacement therapy (CRRT) involves measuring the iCa concentration in two samples: systemic with physiological iCa concentrations and post filter samples with very low iCa concentrations. However, modern blood gas analyzers are optimized for physiological iCa concentrations which might make them less suitable for measuring low iCa in blood with a high concentration of citrate.