C-Reactive Protein and Brain Natriuretic Peptides Harmonization.

The harmonization of laboratory biomarkers is pivotal in ensuring consistent and reliable diagnostic outcomes across different clinical settings. This systematic review examines the harmonization of C-Reactive Protein (CRP) and N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) measurements, both of which are jointly utilized in the diagnosis and management of cardiovascular diseases. To identify relevant studies, we searched the PubMed electronic database using specific medical subject headings and keywords such as C-Reactive Protein, CRP, high sensitivity C-Reactive Protein (hs-CRP), N-terminal pro B-type natriuretic peptide, and NT-proBNP, focusing on publications from June 1 to September 26, 2021.

Definition and application of performance specifications for measurement uncertainty of 23 common laboratory tests: linking theory to daily practice.

Laboratories should estimate and validate [using analytical performance specifications (APS)] the measurement uncertainty (MU) of performed tests. It is therefore essential to appropriately define APS for MU, but also to provide a perspective on suitability of the practical application of these APS. In this study, 23 commonly ordered measurands were allocated to the models defined during the 2014 EFLM Strategic Conference to derive APS for MU.

Harmonization Status of Serum Ferritin Measurements and Implications for Use as Marker of Iron-Related Disorders.

Background: Serum ferritin is considered a suitable biomarker of iron-related disorders. However, data about the comparability of results among commercial measuring systems (MSs) are contradictory. We performed an intercomparison study aimed at verifying the current interassay variability and its impact on clinical application of the test.

A step towards optimal efficiency of HbA measurement as a first-line laboratory test: the TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project.

Objectives: The TOP-HOLE (Towards OPtimal glycoHemOgLobin tEsting) project aimed to validate the HbA enzymatic method on the Abbott Alinity c platform and to implement the HbA testing process on the total laboratory automation (TLA) system of our institution.

Methods: Three different measuring systems were employed: Architect c4000 stand-alone (s-a), Alinity c s-a, and Alinity c TLA. Eight frozen whole blood samples, IFCC value-assigned, were used for checking trueness.

Pancreatic lipase: why laboratory community does not take enough care of this clinically important test?

Although being the recommended laboratory test to diagnose acute pancreatitis, serum pancreatic lipase (LIP) is among the poorly standardized laboratory tests, and laboratory stakeholders often appear to not take enough care of the quality of its measurements. Here we discuss some important issues that, if not correctly managed and solved, make misdiagnosis of acute pancreatitis by using serum LIP a real possibility. First, the current unavailability of a suitable higher-order reference material to be used as common calibrator should be filled up to definitively improve the inter-method bias.

Searching for a role of procalcitonin determination in COVID-19: a study on a selected cohort of hospitalized patients.

Objectives: Procalcitonin (PCT) has been proposed for differentiating viral vs. bacterial infections. In COVID-19, some preliminary results have shown that PCT testing could act as a predictor of bacterial co-infection and be a useful marker for assessment of disease severity.

A Comprehensive Appraisal of Laboratory Biochemistry Tests as Major Predictors of COVID-19 Severity.

Context.—: A relevant portion of coronavirus disease 2019 (COVID-19) patients develop severe disease with negative outcomes. Several biomarkers have been proposed to predict COVID-19 severity, but no definite interpretative criteria have been established to date for stratifying risk.

The internal quality control in the traceability era.

To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty (MU) as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators.

Traceability validation of six enzyme measurements on the Abbott Alinity c analytical system.

Background Laboratory professionals should independently verify the correct implementation of metrological traceability of commercial measuring systems and determine if their performance is fit for purpose. We evaluated the trueness, uncertainty of measurements, and transferability of six clinically important enzyme measurements (alanine aminotransferase [ALT], alkaline phosphatase [ALP], aspartate aminotransferase [AST], creatine kinase [CK], γ-glutamyltransferase [γGT], and lactate dehydrogenase [LDH]) performed on the Abbott Alinity c analytical system. Methods Target values and associated uncertainties were assigned to three pools for each enzyme by using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference measurement procedures (RMPs) and the pools were then measured on the Alinity system.

Impact of total automation consolidating first-line laboratory tests on diagnostic blood loss.

Background Blood loss for laboratory testing may contribute to hospital-acquired anemia. When implementing the core laboratory (core-lab) section, we consolidated first-line tests decreasing the number of tubes previously dispatched to different sites. Here, hypothesized benefits of the amount of blood volume drawn were explored.