Quantification of Difference in Nonselectivity Between In Vitro Diagnostic Medical Devices.

Correct measurement results from in vitro diagnostic (IVD) medical devices (MD) are crucial for optimal patient care. The performance of IVD-MDs is often assessed through method comparison studies. Such studies can be compromised by the influence of various factors.

Moving forward from Cockcroft-Gault creatinine clearance to race-free estimated glomerular filtration rate to improve medication-related decision-making in adults across healthcare settings: A consensus of the National Kidney Foundation Workgroup for Implementation of Race-Free eGFR-Based Medication-Related Decisions.

Purpose: The goals of this paper are to (1) provide evidence and expert consensus to support a unified approach to estimating kidney filtration in adults with stable kidney function using race-free estimated glomerular filtration rate (eGFR) in place of Cockcroft-Gault estimated creatinine clearance (C-G eCrCL) for medical and medication-related decisions, and (2) demonstrate how adjusting eGFR results for an individual's body surface area (BSA) when it is higher or lower than 1.73 m2 will improve results for medication-related decisions.

Summary: C-G eCrCL is predominantly used by US pharmacists to determine eGFR for the purposes of medication-related decisions, even though more accurate eGFR equations exist.

Extent of Equivalence of Results for Urine Albumin among 3 Candidate Mass Spectrometry Reference Measurement Procedures.

Background: Urine albumin (UA) is an important biomarker of chronic kidney disease. Current in vitro diagnostic medical devices (IVD-MDs) for measuring UA are not standardized, and median results among IVD-MDs differ by approximately 45%. Since fixed decision values are used to interpret UA, higher-order reference measurement procedures (RMPs) are needed for metrological traceability.

Decreased Alpha Klotho Expression in Placentas Exposed to Severe Maternal Vascular Malperfusion.

Background: Placental maternal vascular malperfusion (MVM) is characterized by accelerated villous maturation and has been associated with a decrease in the antiaging protein, alpha-klotho (AK). Our aim was to characterize AK protein and gene expression in the placenta and fetal organs.

Methods: We utilized 2 cohorts.

The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine.

The goal of metrological traceability is to have equivalent results for a measurand in clinical samples (CSs) irrespective of the diagnostic medical device (IVD-MD) used for measurements. The International Standards Organization standard 17511 defines requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples used with IVD-MDs. Each step in metrological traceability has an uncertainty associated with the value assigned to a material.

Pre-Medications for Non-Emergency Tracheal Intubation in the United States Neonatal Intensive Care Units.

Background: Premedication in neonates undergoing elective intubation effectively minimizes the negative physiological events of bradycardia, systemic hypertension, intracranial hypertension, and hypoxia. Premedication decreases procedure-related pain and discomfort. This study aimed to evaluate the current practice of pre-intubation medications for non-emergent intubations in preterm and term neonates in the United States.

Recommendations for Setting a Criterion and Assessing Commutability of Sample Materials Used in External Quality Assessment/Proficiency Testing Schemes.

It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs).

Recommendations for Setting a Criterion for Assessing Commutability of Secondary Calibrator Certified Reference Materials.

A secondary higher-order calibrator is required to be commutable with clinical samples to be suitable for use in the calibration hierarchy of an end-user clinical laboratory in vitro diagnostic medical device (IVD-MD). Commutability is a property of a reference material that means results for a reference material and for clinical samples have the same numeric relationship, within specified limits, across the measurement procedures for which the reference material is intended to be used. Procedures for assessing commutability have been described in the literature.

Association of Adverse Childhood Experiences With Accelerated Epigenetic Aging in Midlife.

Importance: Adverse childhood experiences (ACEs) are associated with the risk of poorer health, and identifying molecular mechanisms may lay the foundation for health promotion in people with ACEs.

Objective: To investigate the associations of ACEs with changes in epigenetic age acceleration (EAA), a biomarker associated with various health outcomes in middle-aged adults, in a population with balanced race and sex demographics.

Design, Setting, And Participants: Data for this cohort study were from the Coronary Artery Risk Development in Young Adults (CARDIA) study.

Implementing metrological traceability of C-reactive protein measurements: consensus summary from the Joint Committee for Traceability in Laboratory Medicine Workshop.

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) currently lists the secondary commutable certified reference material (CRM) ERM DA-474/IFCC (DA-474) "C-Reactive Protein in Human Serum" and two generic immunoassay-based method principles as the basis for implementing the metrological traceability of C-reactive protein (CRP) measurements by end-user measurement procedures used by medical laboratories. The current metrological traceability has produced well harmonized results for clinical samples among different end-user measurement procedures. New higher-order pure substance and secondary commutable CRMs have been nominated for listing by the JCTLM.

Guidance on Which Calibrators in a Metrologically Traceable Calibration Hierarchy Must Be Commutable with Clinical Samples.

Equivalent results for the same measurand in clinical samples (CSs), measured using different end-user in-vitro diagnostic medical devices (IVD-MDs), are essential for the application of clinical practice guidelines for diagnosis, treatment, monitoring, or risk assessment. The International Organization for Standardization (ISO) document 17511:2020 specifies how to establish metrological traceability to the highest available reference system component to enable equivalent results among IVD-MDs. Commutability with CSs is an essential property of a reference material used as a calibrator in a calibration hierarchy.

Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results.

Background: Standardized results for laboratory tests are particularly important when their interpretation depends on fixed medical practice guidelines or common reference intervals. The medical laboratory community has developed a roadmap for an infrastructure to achieve standardized test results described in the International Organization for Standardization standard 17511:2020 . Among the challenges to implementing metrological traceability are the availability of fit-for-purpose matrix-based certified reference materials (CRMs) and requirements for regulatory review that differ among countries.

A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

Background: In response to a national call for re-evaluation of the use of race in clinical algorithms, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a Task Force to reassess inclusion of race in the estimation of glomerular filtration rate (GFR) in the United States and its implications for diagnosis and management of patients with, or at risk for, kidney diseases.

Process & Deliberations: The Task Force organized its activities over 10 months in phases to (1) clarify the problem and evidence regarding GFR estimating equations in the United States (described previously in an interim report), and, in this final report, (2) evaluate approaches to address use of race in GFR estimation, and (3) provide recommendations. We identified 26 approaches for the estimation of GFR that did or did not consider race and narrowed our focus, by consensus, to 5 of those approaches.

A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

Background: In response to a national call for re-evaluation of the use of race in clinical algorithms, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a Task Force to reassess inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and management of patients with, or at risk for, kidney diseases.

Process Deliberations: The Task Force organized its activities over 10 months in phases to ( 1 ) clarify the problem and evidence regarding eGFR equations in the United States (described previously in an interim report), and, in this final report, ( 2 ) evaluate approaches to address use of race in GFR estimation, and ( 3 ) provide recommendations. We identified 26 approaches for the estimation of GFR that did or did not consider race and narrowed our focus, by consensus, to five of those approaches.

Clinical utility of a serum biomarker panel in distinguishing prostate cancer from benign prostate hyperplasia.

Prostate-specific antigen (PSA) screening for prostate cancer (PCa) is limited by the lack of specificity but is further complicated in the benign prostatic hyperplasia (BPH) population which also exhibit elevated PSA, representing a clear unmet need to distinguish BPH from PCa. Herein, we evaluated the utility of FLNA IP-MRM, age, and prostate volume to stratify men with BPH from those with PCa. Diagnostic performance of the biomarker panel was better than PSA alone in discriminating patients with negative biopsy from those with PCa, as well as those who have had multiple prior biopsies (AUC 0.

Refractory Pulmonary Interstitial Emphysema in Extreme Premature Newborn.

Pulmonary interstitial emphysema (PIE) occurs when air leaks into the pulmonary interstitium due to overdistension of distal airways, it occurs mainly in neonates with respiratory distress syndrome who need positive pressure ventilation but has also been reported in spontaneously breathing infants. Herein, we report on an extremely low birth weight infant with severe persistent PIE, while on invasive mechanical ventilation (high-frequency oscillatory ventilation, high-frequency jet ventilation, and neurally adjust ventilator assist) managed successfully with 2 weeks of selective right lung ventilation after failure of more conservative measures, including shorter periods of right mainstem intubation, before the prolonged trial that was successful.