EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes.

The EN ISO 15189:2022 standard, titled "Medical laboratories - Requirements for quality and competence," is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1.

Evaluation of genotype imputation using Glimpse tools on low coverage ancient DNA.

Ancient DNA provides a unique frame for directly studying human population genetics in time and space. Still, since most of the ancient genomic data is low coverage, analysis is confronted with a low number of SNPs, genotype uncertainties, and reference-bias. Here, we for the first time benchmark the two distinct versions of Glimpse tools on 120 ancient human genomes from Eurasia including those largely from previously under-evaluated regions and compare the performance of genotype imputation with de facto analysis approaches for low coverage genomic data analysis.

QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories.

Objectives: Clinical laboratories face limitations in implementing advanced quality control (QC) methods with existing systems. This study aimed to develop a web-based application to addresses this gap, and improve QC practices.

Methods: QC Constellation, a web application built using Python 3.

Voluntary imitation of dynamic facial expressions in attention deficit hyperactivity disorder: a facial-behavior analysis.

Objective: The difficulties involved in social interaction among children with attention deficit hyperactivity disorder (ADHD) have been shown in many studies. Based on the knowledge that the imitation of facial expressions is a key factor in social interaction and functionality, the focus of prior studies has been on the evaluation of facial expressions in individuals with ADHD. However, little is known about voluntary facial mimicry in individuals with ADHD.

Validation of SMA screening kits with SMN1 gene analysis in a Turkish cohort.

Objective: It is crucial to start early treatment in Spinal Muscular Atrophy (SMA) with available drugs to stop the progression of the disease, therefore making SMA screening preferable. This study assessed Quantitative Real-Time Polymerase Chain Reaction (qRT-PCR) compared to Multiplex Ligation-dependent Probe Amplification (MLPA) for detecting Spinal Muscular Atrophy (SMA) through SMN1 gene copy number analysis in a Turkish cohort.

Methods: We analyzed 249 DNA samples, previously tested for SMN1 and SMN2 gene deletion via MLPA, using qRT-PCR kits from three different companies.

Machine learning-based clinical decision support using laboratory data.

Artificial intelligence (AI) and machine learning (ML) are becoming vital in laboratory medicine and the broader context of healthcare. In this review article, we summarized the development of ML models and how they contribute to clinical laboratory workflow and improve patient outcomes. The process of ML model development involves data collection, data cleansing, feature engineering, model development, and optimization.

APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.

Objectives: According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest.

Methods: We developed the "APS Calculator" allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU.

Toward the detection of reduced emotion expression intensity: an autism sibling study.

Introduction: Expressing emotions through spontaneous facial expression is an important nonverbal social communication skill. In our study, we aimed to demonstrate that both children with autism spectrum disorder (ASD) and the non-ASD siblings of children with ASD have deficits in this skill.

Method: In this study, we analyzed the six core facial emotion expressions of three distinct groups of children - those diagnosed with ASD (n = 60), non-ASD siblings (n = 60), and typically developed children (n = 60).

Ex vivo expansion of natural killer cells for hematological cancer immunotherapy: a systematic review and meta-analysis.

The present systematic review aimed to investigate natural killer (NK) cell ex vivo expansion protocols within the scope of clinical trials targeting hematological cancer and to conduct a meta-analysis to assess the effect of NK cell infusion on survival. Research articles of clinical studies in which cell products produced by ex vivo expansion, consisting of a certain amount of NK cells and infused to patients with hematological cancer, were included in the systematic review. We conducted a proportion analysis with random effects for product purity and viability values.

Effectiveness of Mesenchymal Stem Cell Therapy for COVID-19 Patients in the Intensive Care Unit: A Case-Control Study.

Objective: Many methods are used in the treatment of coronavirus disease 2019 (COVID-19), which causes acute respiratory distress syndrome (ARDS), and there are conflicting reports in the literature regarding the results of mesenchymal stem cell (MSC) therapy, which is one of those methods. The aim of our study is to evaluate the effect of MSC treatment applied together with standard treatments on survival.

Materials And Methods: This retrospective case-control study evaluates the survival effect of MSC treatment administered to patients treated in intensive care after the development of ARDS due to COVID-19 between March 2020 and March 2021.

An approach for determining allowable between reagent lot variation.

Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from validation and verification experiments to daily quality control procedures. All these procedures verify, on different moments, that the results of a certain examination procedure have analytical performance characteristics (APC) that meet analytical performance specifications (APS) set for a particular intended use.

Detection of COVID-19 by Machine Learning Using Routine Laboratory Tests.

Objectives: The present study aimed to develop a clinical decision support tool to assist coronavirus disease 2019 (COVID-19) diagnoses with machine learning (ML) models using routine laboratory test results.

Methods: We developed ML models using laboratory data (n = 1,391) composed of six clinical chemistry (CC) results, 14 CBC parameter results, and results of a severe acute respiratory syndrome coronavirus 2 real-time reverse transcription-polymerase chain reaction as a gold standard method. Four ML algorithms, including random forest (RF), gradient boosting (XGBoost), support vector machine (SVM), and logistic regression, were used to build eight ML models using CBC and a combination of CC and CBC parameters.

Estimation of Low-Density Lipoprotein Cholesterol Concentration Using Machine Learning.

Objective: Low-density lipoprotein cholesterol (LDL-C) can be estimated using the Friedewald and Martin-Hopkins formulas. We developed LDL-C prediction models using multiple machine learning methods and investigated the validity of the new models along with the former formulas.

Methods: Laboratory data (n = 59,415) on measured LDL-C, high-density lipoprotein cholesterol, triglycerides (TG), and total cholesterol were partitioned into training and test data sets.

Xanthine oxidase enzyme activity in keratoconic corneal epithelium.

Purpose: To assess the activity of xanthine oxidase (XO) enzyme in keratoconic corneal epithelium and to evaluate its relationship with the keratoconus (KC) severity.

Methods: This prospective and randomized study included 66 eyes of 54 KC patients who received corneal collagen cross-linking treatment and 43 eyes of 32 patients who underwent photorefractive keratectomy due to their refractive error. During surgical procedures, the corneal epithelium was mechanically scraped and gathered to analyze the XO enzyme activity spectrophotometrically.

Utilization of biological variation data in the interpretation of laboratory test results - survey about clinicians' opinion and knowledge.

Introduction: To interpret test results correctly, understanding of the variations that affect test results is essential. The aim of this study is: 1) to evaluate the clinicians' knowledge and opinion concerning biological variation (BV), and 2) to investigate if clinicians use BV in the interpretation of test results.

Materials And Methods: This study uses a questionnaire comprising open-ended and close-ended questions.

The use of preanalytical quality indicators: a Turkish preliminary survey study.

Objectives: The utilization of reliable quality indicators (QIs) proven to be suitable for monitoring and improvement tools is one of the best choices to minimize of the risk of errors in all laboratory processes called as total testing process (TTP). In 2008, a Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) established by International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed the Model of Quality Indicators (MQI) complying with requirements of the ISO 15189:2012 standard for laboratory accreditation. They have also been dealing with harmonizing the QIs in most laboratories worldwide since then.

Different effects of heating and freezing treatments on the antioxidant properties of broccoli, cauliflower, garlic and onion. An experimental in vitro study.

Background: Vegetables have some beneficial effects on human health due to their antioxidant compounds, like polyphenols. Cooking leads to many physical and chemical changes to plant structure that can alter the phytochemical compounds of vegetables.

Objectives: To investigate the effects of heat treatment and freezing on the antioxidant properties of garlic, onion, broccoli and cauliflower.

Uncertainty of measurement for 14 immunoassay analytes: application to laboratory result interpretation.

Laboratory tests are an integral part of clinical decision making. Therefore, measurement uncertainty comes into prominence in the context of the accuracy of the laboratory result. This study aims to investigate measurement uncertainty of 14 immunoassay analytes, to compare them with different quality goals and to utilize them in the result interpretation.

Serum glutathione peroxidase, xanthine oxidase, and superoxide dismutase activities and malondialdehyde levels in patients with Parkinson's disease.

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by loss of dopaminergic (DA) neurons in the substantia nigra pars compacta (SNpc). Oxidative stress has been hypothesized to play a major role in the development of PD in various studies. This study assessed to investigate oxidative and anti-oxidative status in PD patients.

Oxidative and nitrosative stress in serum of patients with Parkinson's disease.

Parkinson's disease (PD) is one of the common neurodegenerative disorders. Oxidative stress is considered as a contributing factor to the development of PD. The present study aims to investigate serum oxidative stress status in patients with PD.

A rhinocerotid skull cooked-to-death in a 9.2 Ma-old ignimbrite flow of Turkey.

Background: Preservation of fossil vertebrates in volcanic rocks is extremely rare. An articulated skull (cranium and mandible) of a rhinoceros was found in a 9.2±0.