A survey of Canadian neurologists' perspectives and preferences for laboratory reporting of CSF oligoclonal banding.

Introduction: Cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis aids in the diagnosis of multiple sclerosis (MS). Despite its clinical importance, there is profound variation in processes, reporting, and interpretation of CSF OCB and associated tests/indices across Canadian laboratories. This is likely due to the lack of clear, evidence-based recommendations on CSF OCB analysis processes and reporting.

New Psychoactive Substances: A Canadian perspective on emerging trends and challenges for the clinical laboratory.

The production and use of New Psychoactive Substances (NPS) has skyrocketed over the last decade, causing major challenges for government authorities, public health agencies, and laboratories across the world. NPS are designed to mimic the psychoactive effects of unregulated or controlled drugs, while constantly being modified to evade drug control regulation. Hence, they are referred to as "legal highs", as they are technically legal to sell, possess, and use.

The origin of ferritin reference intervals: a systematic review.

Iron deficiency is a highly prevalent condition, which contributes to unnecessary morbidity, mortality, and health inequity. A serum ferritin concentration of less than 30 μg/L has a high specificity and sensitivity for diagnosing iron deficiency in adults, but the laboratory reported lower limit of normal (LLN) is typically lower. These LLNs might not be rooted in rigorous scientific evidence and might be contributing to structural underdiagnosis of iron deficiency.

Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile.

Background: An analytical benchmark for high-sensitivity cardiac troponin (hs-cTn) assays is to achieve a coefficient of variation (CV) of ≤ 10.0 % at the 99th percentile upper reference limit (URL) used for the diagnosis of myocardial infarction. Few prospective multicenter studies have evaluated assay imprecision and none have determined precision at the female URL which is lower than the male URL for all cardiac troponin assays.

Canadian Society of Clinical Chemists Harmonized Pediatric Lipid Reporting Recommendations for Clinical Laboratories.

Detecting dyslipidemia early is important because atherosclerosis originates in childhood and early treatment can improve outcomes. In 2022, the Canadian Cardiovascular Society (CCS) and Canadian Pediatric Cardiology Association (CPCA) published a clinical practice update to detect, evaluate, and manage pediatric dyslipidemia. However, guidance on its translation into clinical laboratories is lacking.

Validating the NIH LDL-C equation for provincial implementation in Alberta.

Background: LDL-C, a cardiovascular disease risk assessment biomarker, is commonly calculated using the Friedewald equation. The NIH equation overcomes several limitations of the Friedewald equation. Consistent with the Canadian Society of Clinical Chemists (CSCC) lipid reporting recommendations, we assessed the NIH LDL-C equation in Alberta prior to its provincial implementation.

Analytical Unreliability of 25 Hydroxy Vitamin D Measurements in Pre-Term Neonates.

Background: Vitamin D supplementation is common practice for neonates and infants due to limited stores of vitamin D at birth. Although not commonly encountered, vitamin D toxicity can occur due to over-supplementation. However, toxic concentrations are often not included in method validation experiments, and assays often are not validated in the neonatal population.

A Novel Enzymatic Hydrolysis Method for Urine Aldosterone Quantification: A Case for Reassessing Clinical Cut-Offs of Primary Aldosteronism.

Background: Primary aldosteronism (PA) is a common endocrine cause of secondary hypertension. The aldosterone/renin ratio is an important tool for PA screening, and dynamic testing in serum or urine is used to confirm the diagnosis. While LC-MS/MS is considered the gold standard for testing, there is significant interlaboratory variability between the extraction procedures, which can impact diagnostic interpretation.

Plasma Branched-Chain Amino Acid Concentrations and Glucose Homeostasis in Kidney Transplant Recipients and Candidates.

Background: Post-transplant diabetes mellitus (PTDM) encompasses new-onset and previously unrecognized type 2 diabetes. Kidney failure masks type 2 diabetes. Branched-chain amino acids (BCAA) are closely associated with glucose metabolism.

Variation in processes and reporting of cerebrospinal fluid oligoclonal banding and associated tests and calculated indices across Canadian clinical laboratories.

Objectives: Multiple sclerosis is diagnosed based on clinical and laboratory findings, including cerebrospinal fluid (CSF) oligoclonal banding (OCB) analysis. The lack of updated CSF OCB laboratory guidelines in Canada has likely led to variation in processes and reporting across clinical laboratories. As a first step to developing harmonized laboratory recommendations, we examined current CSF OCB processes, reporting, and interpretation across all Canadian clinical laboratories currently performing this test.

The Present and Future of Lipid Testing in Cardiovascular Risk Assessment.

Background: Lipids play a central role in the pathogenesis of cardiovascular disease (CVD), a leading cause of morbidity and mortality worldwide. Plasma lipids and lipoproteins are routinely measured to help identify individuals at high risk of developing CVD and to monitor patients' response to therapy. The landscape of lipid testing is rapidly changing, including new ways to estimate traditional lipid parameters (e.

Defining ferritin clinical decision limits to improve diagnosis and treatment of iron deficiency: A modified Delphi study.

Background: Iron deficiency is highly prevalent worldwide and is an issue of health inequity. Despite its high prevalence, uncertainty on the clinical applicability and evidence-base of iron-related lab test cut-offs remains. In particular, current ferritin decision limits for the diagnosis of iron deficiency may not be clinically appropriate nor scientifically grounded.

Drug checking services as a surveillance tool for clinical laboratories: Examining trends in the unregulated fentanyl supply.

Objectives: Timely assessment and understanding of drug trends is essential for clinical laboratories to effectively respond to the overdose epidemic. In this proof-of-concept study, we sought to determine whether information obtained through Toronto's Drug Checking Services (DCS) and cross-provincial urine drug testing (UDT) data can be used as a surveillance tool for clinical laboratories and discuss the value of collaboration between the clinical laboratory, clinicians, and community partners to optimize patient care.

Design & Methods: Mass spectrometry-based UDT data from LifeLabs Ontario (n = 127,529) and British Columbia (n = 14,848), and drug checking data from Toronto DCS (n = 3,308 drugs or used paraphernalia) was collected between August 2020 and October 2021.

Bias in IGF-1 concentrations and interpretation across three different clinical laboratory assays.

In this study, we compared the DiaSorin LiaisonXL IGF-1 immunoassay to both the Roche Elecsys IGF-1 immunoassay and to the liquid chromatography-high resolution mass spectrometry (LC-MS) IGF-1 assay. Our study shows a constant positive bias in DiaSorin compared to the Roche immunoassay (mean 42 μg/L, 24%), and a proportional positive bias in DiaSorin compared to the LC-MS method (mean 49 μg/L, 29%). Further, we demonstrate the potential clinical impact of this bias by evaluating 43 adult samples, collected over a 2-month period, which were shown to be discrepant based on a chart review.

Emerging synthetic cannabinoids detected by a drug checking service in Toronto, Canada.

Background: Toronto's Drug Checking Service (DCS) provides people who use drugs with information on the chemical composition of their substances and conducts real-time monitoring of the unregulated drug supply. Presented are first known data of three newly detected synthetic cannabinoids (SCs) in Toronto, Ontario.

Methods: The present data are from samples analyzed between April and November 2020.

Canadian Society of Clinical Chemists Harmonized Clinical Laboratory Lipid Reporting Recommendations on the Basis of the 2021 Canadian Cardiovascular Society Lipid Guidelines.

There is limited guidance on laboratory reporting and interpretation of lipids and lipoproteins used in cardiovascular risk stratification. This contributes to inconsistencies in lipid reporting across clinical laboratories. Recently, the Canadian Cardiovascular Society (CCS) published the 2021 CCS guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult.

Diverse psychotropic substances detected in drug and drug administration equipment samples submitted to drug checking services in Toronto, Ontario, Canada, October 2019-April 2020.

Background: The overdose crisis has generated innovative harm reduction and drug market monitoring strategies. In Toronto, Ontario, Canada, a multi-site drug checking service (DCS) pilot project was launched in October 2019. The project provides people who use drugs with information on the chemical composition of their substances, thereby increasing their capacity to make more informed decisions about their drug use and avoid overdose.

Validating the NIH LDL-C equation in a specialized lipid cohort: Does it add up?

Background: Guideline recommendations for the management of lipids in patients at risk for cardiovascular disease is largely based on low-density lipoprotein cholesterol (LDL-C) concentration. LDL-C is commonly calculated by the Friedewald equation, which has many limitations. The National Institutes of Health (NIH) equation better estimates LDL-C, particularly in patients with hypertriglyceridemia and/or low LDL-C.

Xylazine detected in unregulated opioids and drug administration equipment in Toronto, Canada: clinical and social implications.

Background: The North American opioid overdose crisis is driven in large part by the presence of unknown psychoactive adulterants in the dynamic, unregulated drug supply. We herein report the first detection of the psychoactive veterinary compound xylazine in Toronto, the largest urban center in Canada, by the city's drug checking service.

Methods: Toronto's Drug Checking Service launched in October 2019.