A standard to report biological variation data studies - based on an expert opinion.

There is a need for standards for generation and reporting of Biological Variation (BV) reference data. The absence of standards affects the quality and transportability of BV data, compromising important clinical applications. To address this issue, international expert groups under the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) have developed an online resource (https://tinyurl.

Within-subject biological variation estimates using an indirect data mining strategy. Spanish multicenter pilot study (BiVaBiDa).

Objectives: The estimates of biological variation (BV) have traditionally been determined using direct methods, which present limitations. In response to this issue, two papers have been published addressing these limitations by employing indirect methods. Here, we present a new procedure, based on indirect methods that analyses data collected within a multicenter pilot study.

Critical review and meta-analysis of biological variation estimates for tumor markers.

Objectives: Biological variation data (BV) can be used for different applications, but this depends on the availability of robust and relevant BV data. In this study, we aimed to summarize and appraise BV studies for tumor markers, to examine the influence of study population characteristics and concentrations on BV estimates and to discuss the applicability of BV data for tumor markers in clinical practice.

Methods: Studies reporting BV data for tumor markers related to gastrointestinal, prostate, breast, ovarian, haematological, lung, and dermatological cancers were identified by a systematic literature search.

Impact of Individualized Hemolysis Management Based on Biological Variation Cut-offs in a Clinical Laboratory.

Background: Hemolysis is the most common type of preanalytical interference. Cut-offs based on the hemolysis index level can be established using different approaches. The Working Group for Preanalytical Phase of the European Federation of Laboratory Medicine has developed a protocol for hemolysis management based on cut-offs estimated from biological variation (BV) and the use of interpretative comments.

Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management.

ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved.

Structural hemoglobinopathies: Analysis of 128 cases and their relevance in the diabetic control.

Background And Objectives: Hemoglobinopathies are monogenic disorders with autosomal recessive inheritance. In Europe, with increased migration flows these conditions are appearing more frequently in non-endemic regions. HbA testing is useful for evaluating long-term glycaemic status in diabetes mellitus patients.

Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results.

The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters.

Critical appraisal and meta-analysis of biological variation estimates for kidney related analytes.

Objectives: Kidney markers are some of the most frequently used laboratory tests in patient care, and correct clinical decision making depends upon knowledge and correct application of biological variation (BV) data. The aim of this study was to review available BV data and to provide updated BV estimates for the following kidney markers in serum and plasma; albumin, creatinine, cystatin C, chloride, potassium, sodium and urea.

Content: Relevant studies were identified from a historical BV database as well as by systematic literature searches.

Big data and reference intervals: rationale, current practices, harmonization and standardization prerequisites and future perspectives of indirect determination of reference intervals using routine data.

Reference intervals are commonly used as a decision-making tool. In this review, we provide an overview on "big data" and reference intervals, describing the rationale, current practices including statistical methods, essential prerequisites concerning data quality, including harmonization and standardization, and future perspectives of the indirect determination of reference intervals using routine laboratory data.

Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA.

Objectives: Numerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).

Methods: Systematic literature searches were performed to identify BV studies.

Methods for Hemolysis Interference Study in Laboratory Medicine - A Critical Review.

Hemolysis represents an important source of error associated with the pre-analytical phase. Improving the protocols for detection, measurement, management of the parameters affected by the interference, and differentiation between hemolysis and , would favor a personalized management of hemolysis by increasing patient safety. For this, it is essential to agree on the definition of "hemolysis".

Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters.

Background Interpretation of the complete blood count (CBC) parameters requires reliable biological variation (BV) data. The aims of this study were to appraise the quality of publications reporting BV data for CBC parameters by applying the BV Data Critical Appraisal Checklist (BIVAC) and to deliver global BV estimates based on BIVAC compliant studies. Methods Relevant publications were identified by a systematic literature search and evaluated for their compliance with the 14 BIVAC criteria, scored as A, B, C or D, indicating decreasing compliance.

YRNAs overexpression and potential implications in allergy.

Background: Small non-coding RNAs (snRNAs) develop important functions related to epigenetic regulation. YRNAs are snRNAs involved in the initiation of DNA replication and RNA stability that regulate gene expression. They have been related to autoimmune, cancer and inflammatory diseases but never before to allergy.

Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC).

Background: Biological variation (BV) data can be used to set analytical performance specifications (APS) for lipid assays. Poor performance will impact upon the efficacy of international guidelines for cardiovascular risk assessment (CVR) and relevant clinical decision limits. This systematic review applies the Biological Variation Data Critical Appraisal Checklist (BIVAC) to published studies of BV of CVR biomarkers enabling metanalysis of the data.

Mouse Models Applied to the Research of Pharmacological Treatments in Asthma.

Models developed for the study of asthma mechanisms can be used to investigate new compounds with pharmacological activity against this disease. The increasing number of compounds requires a preclinical evaluation before starting the application in humans. Preclinical evaluation in animal models reduces the number of clinical trials positively impacting in the cost and in safety.

General and Specific Mouse Models for Asthma Research.

To study the complexity of human asthma disease, the development of different animal models is needed. Among all different laboratory animals, mice represent a useful tool for the development of asthma. This chapter will describe protocols for designing different animal models applied to the studying of asthma phenotypes.

Review of Mouse Models Applied to the Study of Asthma.

The diversity of asthma phenotypes increases its complexity. Animal models represent a useful tool to elucidate the pathophysiological mechanisms involved in both allergic and nonallergic asthma, as well as to identify potential targets for the development of new treatments. Among all available animal models, mice offer significant advantages for the study of asthma.

Protocols for Exosome Isolation and RNA Profiling.

Exosomes are small extracellular vesicles of multivesicular bodies derived from the cell endosome. Molecules have a characteristic composition both in the membrane and in the carried load. These particles are located in the culture medium of cells in vitro and in vivo body fluids, being synthesized by almost all kind of cells.

Gene Silencing Delivery Methods: Lipid-Mediated and Electroporation Transfection Protocols.

The RNA interference (RNAi) plays an important role in regulation of gene expression. It is a mechanism used by many organisms to silence the expression of genes that control different processes in the cell. The double strand (ds) RNA molecule inhibits gene expression of a targeted gene with high specificity and selectivity.

Chromatin Immunoprecipitation: Application to the Study of Asthma.

Chromatin immunoprecipitation (ChIP) is a technique for studying interactions between proteins and DNA in living cells. A protein of interest is selectively immunoprecipitated from a chromatin preparation, to analyze the DNA sequences involved. ChIP can be used to determine whether a transcription factor interacts with a candidate target gene and to map the localization of histones with posttranslational modifications on the genome.