Routine Laboratory Measurements Research Articles

A Novel Tool for the Rapid and Transparent Verification of Reference Intervals in Clinical Laboratories.

Background/Objectives: We present a software package called reflimR (Version 1.0.6), which enables rapid and transparent verification of reference intervals from routine laboratory measurements. Our method makes it easy to compare the results with specified target values and facilitates the interpretation of deviations using traffic light colors. Methods: The algorithm includes three procedural steps: (a) definition of an appropriate distribution model, based on Bowley's quartile skewness, (b) iterative truncation, based on a modified boxplot method to obtain the central 95% of presumably inconspicuous results, and (c) extrapolation of reference limits from a truncated normal quantile-quantile plot. Results: All algorithms have been combined into one consolidated library, which can be called in the R environment with a single command reflim (x). Using an example dataset included in the package, we demonstrate that our method can be applied to mixed data containing a substantial proportion of pathological values. It leads to similar results as the direct guideline approach as well as the more sophisticated indirect refineR software package. As compared to the latter, reflimR works much faster and needs smaller datasets for robust estimates. For the interpretation of the results, we present an intuitive color scheme based on tolerance ranges (permissible uncertainty of laboratory results). We show that a relatively high number of published reference limits require careful reevaluation. Conclusions: The reflimR package closes the gap between direct guideline methods and the more sophisticated indirect refineR method. We recommend reflimR for the rapid routine verification of large amounts of reference limits and refineR for a careful analysis of unclear or doubtful results from this check.

The association between liver fibrosis score and incident dementia: A nationwide retrospective cohort study.

We assessed the relationship of liver fibrosis score with incident dementia in a large, national sample. For this retrospective cohort study, data of dementia-free individuals aged 40-69 years were derived from electronic records of the largest healthcare provider in Israel. The association between liver fibrosis score (FIB-4), assessed from routine laboratory measurements, and incident dementia was explored through multivariate cox regression models. Of the total sample (N=826,578, mean age 55±8 years at baseline), 636,967 (77%) had no fibrosis, 180,114 (21.8%) had inconclusive fibrosis status and 9497 (1.2%) had high risk for advanced fibrosis. Over a median follow-up of 17 years, 41,089 dementia cases were recorded. Inconclusive liver fibrosis and advanced fibrosis were associated with increased dementia risk (HR=1.09, 95%CI: 1.07-1.11 and HR=1.18, 95%CI: 1.10-1.27, respectively). This association remained robust through seven sensitivity analyses. Liver fibrosis assessed through a serum-based algorithm may serve as a risk factor for dementia in the general population. Liver fibrosis may predict dementia diagnosis in the general population. Inconclusive liver fibrosis was associated with 9% increased dementia risk. Advanced liver fibrosis was associated with 18% increased dementia risk. Findings remained robust in sensitivity analyses and after adjustments.

Paradigm for approaching the forbidden spontaneous phase transition in the one-dimensional Ising model at a fixed finite temperature

The Ising model describes collective behaviors such as phase transitions and critical phenomena in various physical, biological, economical, and social systems. It is well known that spontaneous phase transition at finite temperature does not exist in the Ising model with short-range interactions in one dimension. Yet, little is known about whether this forbidden phase transition can be approached arbitrarily closely—at fixed finite temperature. Here I use symmetry analysis of the transfer matrix to reveal the existence of spontaneous ultranarrow phase crossover (UNPC) at finite temperature in one class of one-dimensional Ising models on decorated two-leg ladders, in which the crossover temperature T0 is determined solely by on-rung interactions and decorations, while the crossover width 2δT is independently, exponentially reduced (δT=0 means a genuine phase transition) by on-leg interactions and decorations. These findings establish a simple ideal paradigm for realizing an infinite number of one-dimensional Ising systems with spontaneous UNPC at desirable T0, which would be characterized in routine laboratory measurements as a genuine first-order phase transition with large latent heat thanks to the ultranarrow δT (say less than one nanokelvin), paving a way to push the limit in our understanding of phase transitions and the dynamical actions of frustration arbitrarily close to the forbidden regime. Published by the American Physical Society 2024

Risk Modeling of Time-Varying Covariates Using an Ensemble of Survival Trees: Predicting Future Cancer Events

The challenge of survival prediction is ubiquitous in medicine, but only a handful of methods are available for survival prediction based on time-varying data. Here we propose a novel method for this problem, using a random forest of survival trees for left-truncated and right-censored data. We demonstrate the advantage of our method on prediction of breast cancer and prostate gland cancer risk among healthy individuals by analyzing routine laboratory measurements, vital signs and age. We analyze electronic medical records of 20,317 healthy individuals who underwent routine checkups and identified those who later developed cancer. In cross-validation, our method predicted future prostate and breast cancers six months before diagnosis with an area under the ROC curve of 0.62±0.05 and 0.6±0.03 respectively, outperforming standard random forest, random survival forest, cox-regression model, dynamic deep-hit and a single survival tree. Our work proposes a new framework for survival risk prediction in time-varying data and our results suggest that computational analysis of data on healthy individuals can improve the detection of those at risk of future cancer development.

Evaluation of Vicarious Somatosensory Experience in Diabetes Mellitus: Bases for Empathy and Social Cognition.

Diabetes Mellitus (DM) is a common metabolic disorder with negative impacts on brain functions. Social cognition and vicarious experience impairments are features of DM. This research aimed to estimate the social cognition and vicarious experience among Jordanian people with diabetes. Cognitive abilities were assessed using the Vicarious Pain Questionnaire (VPQ) and the Mirror Touch Questionnaire (MTQ). Data on disease history, medications, routine laboratory measurements, and anthropometric indices. Patients had lower pain responses and intensity scores, and higher unpleasantness scores than the control group (p < 0.05). Most of the VPQ and MTQ measures were mainly impaired among study participants who had higher education, were not practicing exercises, and were not consuming healthy diets (p < 0.05). The number of responses to the VPQ and average pain intensity were negatively correlated with age and positively correlated with both the serum aminotransferase (AST) concentration and the serum urea concentration (p < 0.05). The average unpleasantness score was positively correlated with the duration of therapy, serum creatinine, and albumin concentrations (p < 0.05). The final regression models for the number of pain responses and localized-generalized included group, practicing exercise, and AST, while the model for the average pain intensity included only the grouping variable. The model for average unpleasantness included grouping, AST, Albumin, consuming a healthy diet, and duration of therapy. The Jordanian diabetic patients who participated in the study had impaired social cognition and vicarious experience. A healthy lifestyle had a significant effect on the scores of the vicarious experience in addition to the level of education. Despite being the first study in Jordan to assess vicarious experience in DM, further studies are needed considering imaging and electrophysiological workup. Besides, further prospective studies are needed to determine the significance of the current study.

Low factor XIII levels and altered fibrinolysis in patients with multiple myeloma

BackgroundAcquired factor FXIII (FXIII) deficiency can be immune- or non-immune mediated and may cause severe bleeding symptoms. The incidence of acquired FXIII deficiency and its etiology in patients with multiple myeloma (MM) are poorly understood. ObjectivesTo assess FXIII levels and the balance of fibrinolysis in newly diagnosed, untreated MM and monoclonal gammopathy of undetermined significance (MGUS) patients. MethodsFXIII activity, mixing studies, FXIII-A2B2 antigen, total FXIII-B antigen were measured in platelet-poor plasma from 17 untreated MM patients, 33 untreated MGUS patients, and 30 age and sex-matched healthy controls. Besides routine laboratory measurements, the balance of coagulation and fibrinolysis was evaluated using quantitative fibrin monomer (FM) test, thrombin-antithrombin assay, α2-antiplasmin activity, plasmin-α2-antiplasmin (PAP) complex, D-dimer, plasmin generation assay, clot lysis assay, and ClotPro-TPA test. ResultsFXIII-A2B2 levels were significantly lower in MM patients compared to controls [median (IQR):14.6 (11.2–19.4) vs. 21.8 (17.1–26.4) mg/L, p = 0.0015], whereas total FXIII-B did not differ between groups. Decrease in FXIII activity was parallel to the decrease in FXIII-A2B2. An immune-mediated inhibitory mechanism was ruled out. Free/total FXIII-B was significantly higher in MM patients compared to MGUS and healthy controls, suggesting an etiology of FXIII-A consumption. In MM and MGUS patients, FM, D-dimer, and PAP complex were significantly elevated compared to controls, indicating hypercoagulability and ongoing fibrinolysis. ConclusionsLow FXIII levels due to consumption were observed in MM patients at diagnosis. Hypercoagulability and ongoing fibrinolysis were detected in MM and MGUS, indicating that a disturbed hemostasis balance is already present in the latter benign condition.

Platelets as Potential Non-Traditional Cardiovascular Risk Factor-Analysis Performed in Healthy Donors.

Abnormal lipid profile, increased glucose level, and elevated body weight are traditional cardiometabolic risk factors; however, the role of platelets in the development of cardiovascular disease (CVD) is increasingly being highlighted. The aim of this study was to select platelet-related parameters (non-genetic molecular and routine laboratory measurements) that may be associated with increased cardiovascular risk among healthy populations. We evaluated the level of platelet indices, platelet-based inflammatory markers, platelet reactivity parameters, and platelet reactive oxygen species (ROS) generation in relation to selected cardiometabolic risk factors. We noted the association between total cholesterol and LDL cholesterol with platelet aggregation and platelet ROS generation. We found the relationship between triglycerides, glucose, and body mass index with the relatively new multi-inflammatory indices (MII-1 and MII-3). Moreover, we noticed that the mean platelet volume-to-lymphocyte ratio in healthy subjects is not a good source of information about platelets and inflammation. We also highlighted that platelet-to-HDL-cholesterol ratio may be a promising prognostic cardiometabolic indicator. The association between platelet-related (especially molecular) and cardiometabolic parameters requires further research. However, the goal of this study was to shed light on the consideration of platelets as a non-traditional cardiovascular risk factor and a crucial element in identifying individuals at high-risk of developing CVD in the future.

The Predictive Value of Serum IL-6 in Pediatric Critically Ill Patients with Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19

Background Unexplained cases of fatal rapidly spreading viral pneumonia were reported in December 2019 in Wuhan, China. A novel type of coronavirus, SARS-COV-2, was isolated during the examination of patients' samples. By May 2019, the novel coronavirus has been responsible for more than 3 million infections worldwide with a case fatality rate up to 7%. Aim of the Work To evaluate the correlation between serum level of IL-6 and cases of COVID-19 and Multisystem inflammatory syndrome in children (MIS-C) progression and outcome. Patients and Methods This is a cohort study that was conducted at the Pediatric Intensive Care Unut, Ain Shams University. It included 53 patients whose median age was 6 years and ranged between 2-10 years. They were divided into 24 patients (45%) with COVID and 29 patients with MIS-C (55%). Laboratory work up done to both groups include : routine laboratory tests (CBC, CRP, ESR, serum ferritin) and measurement of serum IL-6 using ELISA (Normal values up to 7pg/ml). Results Median serum level of IL-6 was higher albeit insignificant in patients with MIS-C as compared to those with COVID (Median:72.7 pg/ml (range: 20.2-140.5 pg/ml) versus a median of 53 pg/ml (range:17.2-293.2) respectively. Serum IL 6 was significantly positively correlated with CRP, ESR and ferritin in both MIS-C and COVID patients groups (p &amp;lt; 0.05). Among MIS-C patients, the best cut off point of serum IL6 to predict severe course and mortality was &amp;gt;168.2 pg/ml, while among COVID patients, the best cut off level was slightly lower &amp;gt;146 pg/ml. Conclusion Systemic inflammation is a feature of COVID and MIS-C in part reflected by increased serum IL 6 and increased ESR, CRP and Ferritin. Increased serum IL 6 has excellent sensitivity to severe MIS-C and COVID with good specificity. It's low predictive value for mortality suggest it's limited value to predict the outcome in severe cases as indicated by the multiple factors interacting in the disease course.

High-throughput microfluidic blood testing to phenotype genetically linked platelet disorders: an aid to diagnosis

AbstractLinking the genetic background of patients with bleeding diathesis and altered platelet function remains challenging. We aimed to assess how a multiparameter microspot-based measurement of thrombus formation under flow can help identify patients with a platelet bleeding disorder. For this purpose, we studied 16 patients presenting with bleeding and/or albinism and suspected platelet dysfunction and 15 relatives. Genotyping of patients revealed a novel biallelic pathogenic variant in RASGRP2 (splice site c.240-1G>A), abrogating CalDAG-GEFI expression, compound heterozygosity (c.537del, c.571A>T) in P2RY12, affecting P2Y12 signaling, and heterozygous variants of unknown significance in the P2RY12 and HPS3 genes. Other patients were confirmed to have Hermansky-Pudlak syndrome type 1 or 3. In 5 patients, no genetic variant was found. Platelet functions were assessed via routine laboratory measurements. Blood samples from all subjects and day controls were screened for blood cell counts and microfluidic outcomes on 6 surfaces (48 parameters) in comparison with those of a reference cohort of healthy subjects. Differential analysis of the microfluidic data showed that the key parameters of thrombus formation were compromised in the 16 index patients. Principal component analysis revealed separate clusters of patients vs heterozygous family members and control subjects. Clusters were further segregated based on inclusion of hematologic values and laboratory measurements. Subject ranking indicated an overall impairment in thrombus formation in patients carrying a (likely) pathogenic variant of the genes but not in asymptomatic relatives. Taken together, our results indicate the advantages of testing for multiparametric thrombus formation in this patient population.

Low Serum Bicarbonate in a Patient With Diabetes Mellitus:: A Quiz

Low Serum Bicarbonate in a Patient With Diabetes Mellitus:: A Quiz

Surgical neonates in a low-resource setting: Baseline nutrition and outcome assessment

IntroductionCongenital anomalies necessitating prolonged fasting have a high mortality in low-income settings, partially due to malnutrition and electrolyte disturbances in the absence of parenteral nutrition (PN). Interventions to address these problems require an accurate baseline quantification of the morbidity and mortality of this population. This prospective study aimed to determine peri-operative morbidity, fluid and electrolyte disturbance, growth, and mortality in neonates with gastroschisis (GS), intestinal atresia (IA), and esophageal atresia (EA) in Uganda. MethodsStandardized patient care of 45 neonates treated in Uganda from Oct 2021 to March 2022 with protocolized fluid and nutrition, vital signs, and routine laboratory measurements. Patient demographics, admission and hospital characteristics are described with mean ± SD. Characteristics of survivors and non-survivors were compared with Fischer's exact tests, logrank tests, and CoX Ph model. ResultsTwenty-eight (62.2%) patients had GS, 4 (8.9%) EA, and 13 (28.9%) IA. Thirty-six percent (16/44) of patients survived to discharge (26% GS, 50% EA, 54% IA) with an average length of stay of 17.3 days ( ± 2.2) (survivors) and 9 days ( ± 1.7) (non-survivors). Average weight was 2.21 kg ( ± 0.62) at presentation, with no significant weight change during the study. Abnormal serum sodium in 64%, phosphate 36.5%, and magnesium 20.8% of measurements. Mortality did not correlate with diagnosis (p = 0.47), electrolyte derangement, or weight change. ConclusionMortality of neonates born with GS, EA, and IA is high in Uganda. Malnutrition and fluid/electrolyte derangements are common and may affect mortality. This study provides a comparison group for studying interventions to improve outcomes for these populations. Type of studyProspective cohort. Level of evidenceLevel 3.

Reevaluation of risk factors for aneurysmal subarachnoid hemorrhage associated epilepsy

BackgroundSymptomatic epilepsy is a common complication of aneurysmal subarachnoid hemorrhage (aSAH) associated with poor outcome. We sought to analyze the risk factors leading to post-SAH epilepsy. MethodsAll consecutive aSAH cases treated between 01/2003 and 06/2016 were retrospectively included. Post-aSAH period was followed up to 03/2020 for the occurrence of epilepsy. Demographic characteristics and previous medical history of the patients, parameters of initial severity, performed treatments, certain early and late complications of aSAH, as well as routine laboratory and vital parameter measurements were collected. Functional outcome was assessed at discharge and 6 months after aSAH using the modified Rankin scale (mRS). ResultsDuring the post-aSAH follow-up (median: 8.93 months/patient), 85 of 948 individuals (9%) in the final analysis developed symptomatic epilepsy (median: 3.43 months). In the majority of cases, epilepsy was diagnosed >3 weeks after aSAH (n = 67, 78.8%) and in survivors with poor outcome at discharge (mRS = 4–5, 15.8% vs. 5.3%, p < 0.0001). Of over 150 analyzed potential risk factors, the following parameters were independently associated with the risk of symptomatic epilepsy after aSAH: thyroid dysfunction (aHR = 1.81, p = 0.029), need for decompressive craniectomy (aHR = 2.32, p = 0.011) and shunt placement (aHR = 1.94, p = 0.022), prolonged tachycardia (≥4 days, aHR = 2.06, p = 0.025), as well as anemia signs (mean red blood cell count <3.6 × 1012 /L [aHR = 2.4, p = 0.015] and mean hematocrit <31% [aHR = 2.13, p = 0.044]) during first 2 weeks after aSAH. ConclusionSymptomatic epilepsy occurs predominantly in individuals with poor outcome at discharge and after the acute phase of aSAH. Knowledge of risk factors associated with aSAH-related epilepsy might help in early identification and treatment of compromised individuals, and therefore, help to improve their outcome.

412.7: Pre-transplant Hyperparathyroidism and Adverse Posttransplant Outcomes in Kidney Transplant Recipients

Introduction: Whether correction of severe hyperparathyroidism (HPT) is required before kidney transplantation is subject of debate, as previous studies investigating the impact of pretransplant HPT on graft and patient outcomes showed conflicting results. We aimed to assess whether pretransplant serum PTH levels are associated with the risk of delayed graft function (DGF), death censored graft failure (DCGF), or mortality. Additionally, we focused on a subgroup of patients with very high pre-transplant PTH levels (≥81 pmol/L; ≥764 pg/mL). Methods: We performed a single-center cohort study including patients who underwent kidney transplantation between 1986 and 2020. Donor and recipient demographic data, medical information and routine laboratory measurements were extracted from the local transplant registry. We performed multivariable logistic regression and Cox regression analyses to study associations between PTH and DGF (persisting dialysis requirement for up to 7 days post-transplant), DCGF (return to dialysis or re-transplantation), or all-cause mortality, respectively. We also compared these outcomes for patients in the highest vs. lowest PTH decile for each endpoint. Results: A total of 1576 kidney transplant recipients (KTRs) (51.6 ± 14.0 years-old, 42.7% male) were included. Donor age was 51.2 ± 13.5 years, 785 (49.8%) patients received a graft from a living donor, and 535 (33.9%) patients underwent a pre-emptive transplantation. Median (IQR) pretransplant serum PTH concentration was 24.3 (12.8 – 44.6) pmol/L. Corrected calcium increased while PTH and corrected phosphate decreased within the first 3 months post-transplant, even in patients with pre-transplant PTH >81 pmol/L (Figure 1A-C). Pre-transplant PTH was not associated with DGF (Table 1). During median follow-up of 5.0 (2.2 – 8.4) years, 201 (12.8%) patients developed DCGF. In fully adjusted Cox regression analyses, PTH was not associated with DCGF (Table 1). Additionally, patients with PTH >81 pmol/L (N=121) did not have an increased risk of DGF (HR 1.67 [95% CI 0.62 – 4.55], P=0.65) or DCGF (HR 0.86 [95% CI 0.47 – 1.61], P=0.65), compared with those in the lowest PTH decile. During median follow-up of 5.2 (2.9 – 9.0) years, 474 (30.1%) patients deceased. In age- and sex-adjusted analyses, a higher serum PTH was associated with an increased risk of all-cause mortality, but this association lost significance upon multivariable adjustment (Table 1). When comparing KTRs with PTH levels in the highest vs. lowest decile, there was also no association with mortality (HR 0.96 [95% CI 0.62 – 1.48], P=0.65). Conclusion: In this cohort study, pre-transplant serum PTH was not associated with an increased risk of DGF, DCGF or mortality after transplantation. Subgroup analyses in patients with severe HPT yielded similar results. Our data do not support the requirement of pre-transplant parathyroidectomy in patients with (severe) hyperparathyroidism to improve graft or patient survival.

Prognosis of systemic inflammation at an early stage of cirrhosis using the monocyte-to-lymphocyte ratio during malnutrition risk screening: a prospective cohort study

ABSTRACT Objective To determine whether the monocyte-to-lymphocyte ratio (MLR), as a systemic inflammation index, predicts malnutrition risk during the early stages of cirrhosis. Methods We conducted a single-center prospective cohort study, enrolling patients from June 2016 to September 2020. The patients underwent malnutrition risk assessments upon admission. The patients were classified into five clinical stages according to portal hypertension. The malnutrition risk was scored using the Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT) and validated by the Nutritional Risk Screening 2002 (NRS-2002) or Liver Disease Undernutrition Screening Tool (LDUST). Routine clinical laboratory measurements were performed to calculate the MLR, Child–Turcotte–Pugh (CTP) class, and model for end-stage liver disease (MELD) score. The patients were followed up for 2 years. Results Among the 154 patients with cirrhosis, 60 had compensated cirrhosis and 94 had decompensated cirrhosis. The optimal cutoff value of the MLR, >0.4, was effective in predicting malnutrition related to death or liver transplantation. Those with a high malnutrition risk defined by the NRS-2002 or RFH-NPT had a higher MLR than those with a low malnutrition risk. For patients with class A CTP cirrhosis or a MELD score of <10, an MLR cutoff of <0.4 significantly distinguished more patients with a low malnutrition risk than those with a high malnutrition risk. Both the RFH-NPT score and MLR increased significantly across the decompensated cirrhosis substages. Interestingly, the MLR exhibited a positive correlation with the RFH-NPT score until varices appeared, but the correlation was the highest at the substage of a history of variceal bleeding (r = 0.714, P = 0.009). Multivariable analysis demonstrated that an MLR of >0.4 was an independent factor for malnutrition risk by screening with the RFH-NPT, and this was confirmed using the LDUST and NRS-2002. Conclusion Immune-related inflammatory dysfunction predicts malnutrition risk during the early stages of cirrhosis.

Development and validation of an early warning score to identify COVID-19 in the emergency department based on routine laboratory tests: a multicentre case–control study

ObjectivesIdentifying patients with a possible SARS-CoV-2 infection in the emergency department (ED) is challenging. Symptoms differ, incidence rates vary and test capacity may be limited. As PCR-testing all ED patients...

Neutrophil-Lymphocyte Ratios in Dry Age-Related Macular Degeneration

ABSTRACT Inflammation plays a role in the etiopathogenesis of age-related macular degeneration (AMD). A retrospective case-control study was conducted to assess the significance of the neutrophil-lymphocyte ratio (NLR) as a systemic inflammatory indicator in dry AMD. Clinical diagnosis and complete blood count (CBC) results were extracted from medical records for patients with dry AMD and age/sex-matched controls. This study included 90 patients diagnosed with dry AMD and 270 controls without AMD. There were no significant differences in the CBC results between the cases and controls. Patients with dry AMD had a slightly higher mean NLR than controls; however, this increase was not significant (P = .13). In the NLR model, age and sex were significant factors affecting the NLR values in the dry AMD group (P = .03 and 0.01, respectively). The NLR alone cannot predict dry AMD. Therefore, exploring other routine laboratory measurements may shed light on early disease prediction and prevention.

Low serum albumin as a risk factor for delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage: eICU collaborative research database analysis.

Delayed cerebral ischemia (DCI) represents a devastating complication of aneurysmal subarachnoid hemorrhage (aSAH) and is a significant predictor of morbidity and mortality. Recent studies have implicated inflammatory processes in the pathogenesis of DCI. aSAH patient data were retrospectively obtained from the eICU Collaborative Research Database (eICU CRD). Multivariable logistic regression models and receiver operating characteristic (ROC) curve analyses were employed to assess the association between low serum albumin (<3.4 g/dL) and clinical endpoints: DCI and in-hospital mortality. Among 276 aSAH patients included in the analysis, 35.5% (N.=98) presented with low serum albumin levels and demonstrated a higher incidence of DCI (18.4% vs. 8.4%, OR=2.45, 95% CI=1.17, 5.10; P=0.017) and in-hospital mortality (27.6% vs. 16.3%, OR=1.95, 95% CI=1.08, 3.54; P=0.027) compared to patients with normal admission albumin values. In a multivariable model controlling for age and World Federation of Neurosurgical Societies grade, low serum albumin remained significantly associated with DCI (OR=2.52, 95% CI=1.18, 5.36; P=0.017), but not with in-hospital mortality. A combined model for prediction of DCI, encompassing known risk factors in addition to low serum albumin, achieved an area under the curve of 0.65 (sensitivity = 0.55, specificity = 0.75). Serum albumin, a routine and inexpensive laboratory measurement, may potentially aid in the identification of patients with aSAH at risk for the development of DCI.

Point-of-care test for rapid assessment of blood lithium levels in women with bipolar disorder during perinatal period

IntroductionDetermination of lithium levels in serum has become a standard of care due to its narrow therapeutic rang, thus an immediate test for determination of blood lithium may contribute to minimize toxicit, to avoid relapse and to ensure treatment adherence. This is particularly relevant during pregnancy and early postpartum because pharmaokinetic changes in renal physiology.ObjectivesThe aim of this study is verify Medimate point-of-care method performance and systematically compare it with the routine laboratory measurement of lithium.MethodsThis cross-sectional method comparison study was conductec in the Unit of Perinatal Mental Health in the Hospital Clinic of Barcelona. Pearson and Bland-Altman analyses were performed to assess the accuracy, precision and correlation between the capillary electrophoresis technology (Medimate MiniLab) and the ion selective electrode (ISE) potentiometry method (AVL 9180).ResultsTwenty-five women with bipolar disorder in treatment with lithium during perinatal period were enrolled, corresponding to 75 blood specimens for analyses. Correlation (r), mean difference (bias), and 95% limit of agreement (LOA) of the point-of-care method [r=0.917; bias 0.0021 (95% LOA; 0.440, 0.619) mEq/L], showed that difference between ISE method and capillary electrophoresis technology was not statistically significant.ConclusionsConsidering the practicality, the microchip capillary electrophoresis technology provides a simple and highly affordable way of measuring lithium levels in a single drop of blood outside the clinical laboratory. The Medimate point-of-care system (POC) appears well adapted for the rapid and specific detection of lithium as an alternative to the current ISE procedure.DisclosureNo significant relationships.

MO934: Correlation Between Sarcopenia and Oral Health in Patients on Chronic Haemodialysis

Abstract BACKGROUND AND AIMS Patients on haemodialysis have signs of chronic systemic inflammation and a higher incidence of sarcopenia. Poor oral health can also trigger systemic inflammation and thus affect sarcopenia. The aim of the study was to examine oral health and the presence of sarcopenia in patients on chronic haemodialysis and to determine whether there is a correlation between them. METHOD This study included 100 patients on chronic haemodialysis at the Clinical University Hospital `Sestre Milosrdnice’ in Zagreb, who underwent oral status, routine laboratory measurements, bioimpedance analysis of body composition and measurement of hand grip strength. RESULTS Of the total number of participants (N = 100), 28.0% had sarcopenia. The majority of participants were male (61.0%). Poor oral hygiene was recorded in as many as 39.0% of participants, while 46.0% had their last visit to the dentist several years ago. It is interesting to note that 64.3% of patients with confirmed sarcopenia were last examined by a dentist several years ago, while in those without sarcopenia the proportion was 38.9%. The median total number of erupted teeth in all patients was 12.0 (7.0–23.0). A positive correlation of the total number of erupted teeth and erupted premolars with sarcopenia was confirmed. CRP was significantly elevated in patients with sarcopenia (P = 0.035), in contrast to those without sarcopenia (3.45 versus 2.70). A total of 51% of patients had increased calculus formation, 49% had oral candidiasis and 38% periodontitis, with as many as 24% of petechiae on the mucosa and 22% of dental caries. A total of 8% of patients had an ammonia breath and 4% had a metallic taste in their mouth. Of all the examined signs and symptoms of oral health, significant differences were observed only in the incidence of dental caries, which was significantly more common in the group that did not have sarcopenia (P = 0.031). However, it should be noted that in patients with sarcopenia, total edentulousness was present in 17.9% as opposed to 9.7% in patients who did not have sarcopenia, i.e. 12% of the total number of participants had total edentulousness. Moreover, in 21% of patients with sarcopenia, a complete denture was present in combination with a partial denture, while that was the case in only 9.7% of patients without sarcopenia. CONCLUSION This study confirmed poorer oral health in haemodialysis patients who had sarcopenia. Therefore, intervention studies are needed to improve oral health of patients on HD, which could possibly influence the incidence and severity of sarcopenia.

Two-year administration data of an oral testosterone undecanoate (TU) formulation in hypogonadal men

ABSTRACT Introduction An oral testosterone (T) replacement therapy (TRT) would be the preferred administration route for many hypogonadal men. Until recently, the only oral TRT approved in the US was methyl-T which has been associated with hepatotoxicity. The safety of a novel oral T undecanoate (TU) formulation was evaluated in hypogonadal men with two-year follow up. Methods Two open-label, multicenter, dose-titration trials were conducted in hypogonadal men (serum T ≤ 300 ng/dL) age 18-75 years. Trial I was a randomized, active-controlled, 2-arm, 12-month study. Trial 2 was a long-term extension of those who completed Trial 1. Statistical analyses were only conducted with the subjects who completed Trial 1 and continued treatment in Trial 2, thus providing up to 2 full years of data. Safety was assessed by physical exam, AE reporting, and routine clinical laboratory measurements. Results Overall, 86 subjects participated in both studies. T concentration increased from 193.75 ± 9.44 ng/dL (Mean ± SEM) at baseline (BL) to 475.5 ± 49.7 ng/dL after 24 Mo of therapy with oral TU, and 84% of men achieved T in eugonadal range (300-1000 ng/dL) after 90 days of therapy. Mean T concentrations remained in the eugonadal range throughout Trial 2. There were no clinically significant changes in liver function tests – ALP (64.05 ± 1.95 to 53.74 U/L ± 1.86 U/L), ALT (27.8 ± 1.40 to 26.7 ± 1.6 U/L), AST (21.6 ± 0.76 to 22.0 ± 1.0 U/L), and bilirubin (0.58 ± 0.03 to 0.52 ± 0.03 mg/dL) throughout the two studies. At d270, one subject had an ALT level of 227 U/L, which was &amp;gt; 4x the ULN (ULN for ALT = 45 U/L). Despite continued use of oral TU, ALT was measured again on d290, and the level dropped to 87 U/L, &amp;lt; 2x ULN. This was the only instance of an LFT elevation. There was a modest initial increase in prostate-related growth endpoints (i.e. PSA and prostate volume) that stabilized over time. Although there was a slight increase in prostate-growth related endpoints, there were no significant changes in IPSS total score (-0.06 ± 3.9 vs BL). There were significant, yet modest, increases in mean HCT (44.3 ± 0.3 to 46.6 ± 0.5%, p &amp;lt; 0.001) and cuff systolic BP (127.1 ± 1.2 to 131.8 ± 1.67 mmHg vs BL, p = 0.006). The change in CV endpoints, including HDL-C, hematocrit, and BP, changed initially and stabilized throughout the 2 trials. For example, systolic BP varied 3 – 6 mm Hg from BL throughout the study. Conclusion This oral TU formulation is an option for hypogonadal men and has a safety profile consistent with other approved T products, such as a rise in hematocrit and a decrease in HDL-C. Notably, no evidence of liver toxicity was observed over 2 years. The long-term efficacy and safety profile of oral TU may provide a treatment option that avoids issues associated with other TRTs, such as injection site pain or transference to partners and children. Disclosure Work supported by industry: yes, by Clarus Therapeutics. A consultant, employee (part time or full time) or shareholder is among the authors (Clarus Therapeutics).