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BackgroundIntraoperative parathyroid hormone (iPTH) testing is often used to confirm successful removal of hypersecreting parathyroid glands during parathyroidectomy. Unfortunately, the iPTH test can be a time-consuming and highly variable process that occurs while the patient is under anesthesia. We set out to improve iPTH lab efficiency and variability.MethodsWe performed a retrospective review of 85 patients who underwent parathyroidectomy at our institution from October 2017 to October 2019. Each step of the iPTH lab reporting process was recorded and analyzed. Three simulations were performed of the entire process. We then established interventions to modify inefficiencies in the process and studied 21 patients who underwent parathyroidectomy at our institution from November 2019 to March 2020.ResultsTwenty-five minutes of time inherent to the process were identified. Four critical steps were identified as modifiable steps in the process: 1. Operating room (OR) blood draw ---> lab receipt. 2. Lab receipt ---> placement on centrifuge. 3. Removal from centrifuge ---> placement on PTH machine. 4. PTH machine result ---> OR verbal report. We improved iPTH lab efficiency by 19%, decreasing the average lab result from 45 to 36 minutes ( P = .001). We improved iPTH lab variability by 62%, decreasing the standard deviation from 21 to 8 minutes ( P = .001).DiscussionUtilizing a team-based approach to identify and expedite critical steps in the iPTH lab process can make a significant improvement in iPTH lab efficiency, improving patient care by decreasing total anesthesia time.

Rationale Published studies examining the effects of cannabis have largely utilized forms of cannabis that are not representative of the legal market products currently available. Objectives The present study aimed to characterize naturalistic use of legal market flower and edible products by examining associations among blood cannabinoids and amount of THC consumed as well as physiological, cognitive, and subjective effects in users of edible and flower forms. Method Eighty-four participants who used cannabis at least 1 × /week (55 flower cannabis using participants; 29 edible cannabis using participants mean age = 31.95 years, 44% female) participated. At the experimental appointment in our mobile laboratory, participants completed a blood draw to assess plasma cannabinoids, measures of heart rate, subjective drug effects, and cognition both before and after ad libitum use of legal market flower or edible cannabis. Results Average self-reported THC consumed was 15.97 mg (SD = 22.40) in edible users and 51.25 mg (SD = 45.23) in flower users. In the edible group, but not the flower group, strong correlations emerged between self-reported ad libitum THC consumed and plasma THC. Plasma THC was significantly higher after use of inhaled cannabis, but similar levels of plasma THC metabolites and similar levels of subjective intoxication and verbal memory impairment were observed in both flower and edible users. Conclusions Findings support strong correlations among ad libitum THC consumed and THC plasma levels after edible cannabis use and suggest few differences in intoxication and impairment between edible and flower cannabis users after ad libitum use. This novel study provides important preliminary data on the pharmacology and effects of legal market edible cannabis.

Objective We sought to improve seropositive rheumatoid arthritis (RA) risk prediction using a novel weighted genetic risk score (wGRS) and preclinical plasma metabolites associated with RA risk. Predictive performance was compared to previously validated models including RA-associated environmental factors. Methods This nested case-control study matched incident seropositive RA cases (meeting ACR 1987 or EULAR/ACR 2010 criteria) in the Nurses’ Health Studies (NHS) to two controls on age, blood collection features, and post-menopausal hormone use at pre-RA blood draw. Environmental variables were measured at the questionnaire cycle preceding blood draw. Four models were generated and internally validated using a bootstrapped optimism estimate: (a) base with environmental factors (E), (b) environmental, genetic and gene-environment interaction factors (E + G + GEI), c) environmental and metabolic factors (E + M), and d) all factors (E + G + GEI + M). A fifth model including all factors and interaction terms was fit using ridge regression and cross-validation. Models were compared using area under the receiver operating characteristic curve (AUC). Results 150 pre-RA cases and 455 matched controls were included. The E model yielded an optimism-corrected AUC of 0.622. The E + M model did not show improvement over the E model (corrected AUC 0.620). Including genetic factors increased prediction, producing corrected AUCs of 0.677 in the E + G + GEI model and 0.674 in the E + G + GEI + M model. Similarly, the performance of the cross-validated ridge regression model yielded an AUC of 0.657. Conclusion Addition of wGRS and gene-environment interaction improved seropositive RA risk prediction models. Preclinical metabolite levels did not significantly contribute to prediction.

Ethanol stability in antemortem blood stored under various conditions has been widely studied. Most such studies have somewhat limited sample size (

Objective:The aims of this study were to examine the efficacy among various vitamin D supplementation regimens on serum 25-hydroxyvitamin D (25(OH)D) concentrations and determine the minimal dose rate required to achieve sufficient serum concentrations (≥75 nmol/l) among older adults in long-term care (LTC).Design:A 1-year medical history was abstracted from medical records, and a one-time blood draw to measure serum 25(OH)D concentrations was obtained. Individuals were stratified into vitamin D-supplemented and non-supplemented groups. The supplemented group was further categorised into four treatment forms: single-ingredient vitamin D2or3, multivitamin, Ca with vitamin D or combination of the three, and by daily prescribed doses: 0–9·9, 10–19·9, 20–49·9, 50–99·9 and >100 μg/d.Setting:Five LTC communities in Austin, Texas.Participants:One hundred seventy-three older (≥65 years) adults.Results:Of the participants, 62% received a vitamin D supplement and 55% had insufficient (≤75 nmol/l) 25(OH)D serum concentrations. Individuals receiving single-ingredient vitamin D2or3 supplementation received the highest daily vitamin D mean dose (72·5 μg/d), while combination of forms was the most frequent treatment (44%) with the highest mean serum concentration (108 nmol/l). All supplementation doses were successful at reaching sufficient serum concentrations, except thoseConclusions:Based on the predictive equation, results suggest that supplementation of 37·5 μg/d of vitamin D2or3 or combination of vitamin D is most likely to achieve sufficient serum 25(OH)D concentrations in older adults in LTC.

Background Between December 2018 and January of 2019, we evaluated the accuracy of the point-of-care Hepatitis C (HCV) antibody test (POC; OraQuick HCV) used at a community-based needle and syringe exchange program serving persons who inject drugs in Tallinn, Estonia. Methods We compared the results of screening for HCV antibodies by OraQuick (oral swab) and enzyme immunoassay (EIA; blood draw) and assessed test results implications in a high prevalence setting. Findings Of the 100 participants, 88 (88%) had reactive POC test results, and 93 were HCV antibody positive on EIA testing. Sensitivity, specificity and negative predictive value (NPV) for the POC assay with EIA as the relevant reference test were as follows: 94.6% (95% CI 90.0–99.2%), 100% and 58.3% (95% CI 30.4–86.2%). Of the 12 testing, HCV-negative with the POC only 7 (58.3%) were true negatives. Conclusions Oral swab rapid testing HCV screening in this nonclinical setting was sensitive and specific but had unacceptably low NPV. In high prevalence settings, POC tests with high sensitivity and that directly measure HCV RNA may be warranted.

Purpose Low energy availability in males needs more original research to understand its health and performance consequences. The aim of the study was to induce low energy availability in previously healthy male endurance athletes by reducing energy availability by 25% for 14 consecutive days and measure any potential changes in performance, health, mental state or energy markers. Methods Energy availability was reduced in 12 trained, well-trained and elite endurance athletes by increasing energy expenditure and controlling energy intake. After intervention, health was assessed by blood draw, body composition was measured, energy markers by measuring resting energy expenditure, performance with three specific tests (measuring endurance, agility and explosive power) and two questionnaires were used for psychological assessment (the Three Factor Eating Questionnaire and Well-being questionnaire). Results Reduced energy availability (22.4 ± 6.3 kcal/kg FFM/day) caused significantly lower haemoglobin values (t(12) = 2.652, p = 0.022), there was a tendency for lower iron and IGF-1 (p = 0.066 and p = 0.077, respectively). Explosive power was reduced (t(12) = 4.570, p = 0.001), lactate metabolism was altered and athletes reported poorer well-being (t(12) = 2.385, p = 0.036). Cognitive restriction was correlated with energy availability (r = 0.528, p = 0.039). Conclusion This is the first research providing direct evidence that suboptimal energy availability negatively impacts explosive power before hormonal changes occur in male endurance athletes. It is also the first to show direct association of low energy availability and higher cognitive restriction. We also observed worse well-being and lower haemoglobin values. 25% of energy availability reduction as not enough to elicit changes in resting energy expenditure.

Late preterm (LPT) infants are at an increased risk for hyperbilirubinemia. Accurate identification and early treatment are needed for optimal health outcomes. In a newborn nursery at an academic medical center, bilirubin levels were drawn at 24 hours of life, per protocol. These infants were rarely treated at this time. Rather, predischarge bilirubin levels (at about 48 hours of life) would indicate treatment, often leading to increased length of hospital stay. The practice change evaluation was conducted using retrospective medical record review. Practice change to test serum bilirubin levels at 36 hours of life rather than 24 hours of life. Compliance with the practice change was achieved (P < .05). More LPT infants were identified and treated for hyperbilirubinemia without an increase in length of stay. Readmissions for hyperbilirubinemia and blood draw rates also declined. Although more LPT infants were identified and treated for hyperbilirubinemia, there is room for improvement, and increased adherence to the policy might yield an even greater impact on quality and safety of care surrounding bilirubin management.

Many emerging technologies are reliant on circulating cell-free DNA (cfDNA) and cell-free RNA (cfRNA) applications in the clinic. However, the impact of diurnal cycles or daily meals on circulating analytes are poorly understood and may be confounding factors when developing diagnostic platforms. To begin addressing this knowledge gap, we obtained plasma from four healthy donors serially sampled five times during 12 h in a single day. For all samples, we measured concentrations of cfDNA and cfRNA using both bulk measurements and gene-specific digital droplet PCR. We found no significant variation attributed to blood draw number for the cfDNA or cfRNA. This indicated that natural diurnal cycles and meal consumption do not appear to significantly affect abundance of total cfDNA, total cfRNA, or our two selected cfRNA transcripts. Conversely, we observed significant variation between individual donors for cfDNA and one of the cfRNA transcripts. The results of this work suggest that it will be important to consider patient-specific baselines when designing reliable circulating cfDNA or cfRNA clinical assays.

SiO2 Medical Products, Inc. developed hybrid blood collection tubes (BCTs) that combine the breakage resistance of plastic and a shelf life approaching that of glass. These blended attributes provide improved BCT safety and reliability for patients and clinical workers. A shelf life of at least 2 y with less than 10% draw volume variation was demonstrated on evacuated hybrid BCTs, which is approximately 7 times longer than standard polyethylene terephthalate (PET) BCTs. This translates into more consistent and reliable blood draw volumes over a longer shelf life. The moisture vapor barrier of hybrid BCTs is 5 times lower than that of PET BCTs, which significantly reduces preservative evaporation over their shelf life. As a result, the risk of preservative gelation and alteration to the blood-to-preservative ratio mix is practically eliminated. Cyclic olefin polymer (COP) exhibits superior impact resistance to breakage because of its high ductility and impact strength and is not influenced by defects and flaws as is glass. Although COP has a mechanical toughness comparable with that of PET, it maintains this over a wider range of temperatures (–70 to 121 °C). As a result, COP can tolerate steam sterilization and cold storage temperatures without mechanical fatigue, deformation, or breakage. Lastly, extreme centrifugation of water-filled BCTs did not impose breakage of any kind.

Circulating cell-free DNA (cfDNA) is rapidly transitioning from discovery research to an important tool in clinical decision making. However, the lack of harmonization of preanalytic practices across institutions may compromise the reproducibility of cfDNA-derived data and hamper advancements in cfDNA testing in the clinic. Differences in cellular genomic contamination, cfDNA yield, integrity, and fragment length have been attributed to different collection tube types and anticoagulants, processing delays and temperatures, tube agitation, centrifugation protocols and speeds, plasma storage duration and temperature, the number of freeze-thaw events, and cfDNA extraction and quantification methods, all of which can also ultimately impact subsequent downstream analysis. Thus, there is a pressing need for widely applicable standards tailored for cfDNA analysis that include all preanalytic steps from blood draw to analysis. The NCI's Biorepositories and Biospecimen Research Branch has developed cfDNA-specific guidelines that are based upon published evidence and have been vetted by a panel of internationally recognized experts in the field. The guidelines include optimal procedures as well as acceptable alternatives to facilitate the generation of evidence-based protocols by individual laboratories and institutions. The aim of the document, which is entitled “Biospecimen Evidence-based Best Practices for Cell-free DNA: Biospecimen Collection and Processing,” is to improve the accuracy of cfDNA analysis in both basic research and the clinic by improving and harmonizing practices across institutions.

The present study investigated the impact of 12 weeks of pulsed electromagnetic field (PEMF) therapy on peripheral vascular function, blood pressure (BP), and nitric oxide in hypertensive individuals. Thirty hypertensive individuals (SBP > 130 mm Hg and/or MAP > 100 mm Hg) were assigned to either PEMF group (n = 15) or control group (n = 15). During pre‐assessment, participants underwent measures of flow‐mediated dilation (FMD), BP, and blood draw for nitric oxide (NO). Subsequently, they received PEMF therapy 3x/day for 12 weeks and, at conclusion, returned to the laboratory for post‐assessment. Fifteen participants from the PEMF group and 11 participants from the control group successfully completed the study protocol. After therapy, the PEMF group demonstrated significant improvements in FMD and FMD(NOR) (normalized to hyperemia), but the control group did not (P = .05 and P = .04, respectively). Moreover, SBP, DBP, and MAP were reduced, but the control group did not (P = .04, .04, and .03, respectively). There were no significant alterations in NO in both groups (P > .05). Twelve weeks of PEMF therapy may improve BP and vascular function in hypertensive individuals. Additional studies are needed to identify the mechanisms by which PEMF affects endothelial function.

Background: The stability of proteins in the collecting tubes after blood draw is critical to the measured concentrations of the proteins. Although the guidelines issued by the Clinical and Laboratory Standards Institute (CLSI) suggest centrifugation should take place within 2 h of drawing blood, it is very difficult to follow these guidelines in hospitals or clinics. It is necessary to study the effect of times to blood processing on the stability of the proteins of interest. Methods: In this work, the plasma proteins of interest were those relevant to dementia, such as amyloid β 1–40 (Aβ1–40), Aβ1–42, Tau protein (Tau), and α-synuclein. The times to blood processing after blood draw ranged from 0.5 to 8 h. The storage temperatures of blood were room temperature (approx. 25°C) and 30°C. After storage, blood samples were centrifuged at room temperature to obtain plasma samples. Ultrasensitive immunomagnetic reduction was applied to assay these proteins in the plasma. Results: The levels of plasma Aβ1–40, Tau, and α-synuclein did not significantly change until 8 h after blood draw when stored at room temperature. Plasma Aβ1–42 levels did not change significantly after 8 h of storage at room temperature before blood processing. Higher storage temperatures, such as 30°C, for blood samples accelerated the significant variations in the measured concentrations of Aβ1–40, Tau, and α-synuclein in plasma. Conclusion: According to these results, for clinical practice, it is suggested that blood samples be stored at room temperature for no longer than 4.5 h after blood draw until centrifugation for the assay of dementia biomarkers in plasma.

The characterization of the effects of solar UVR on a broad set of circulating markers in systemic immunity and inflammation may provide insight into the mechanisms responsible for the UVR associations observed for several benign and malignant diseases. We examined the associations between exposure to solar UVR and circulating levels of 78 markers among 1,819 individuals aged 55–74 years who participated in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial using multiplex assays. Solar UVR was derived by linking the geocoded locations of 10 screening centers across the continental United States and the date of blood draw to the National Solar Radiation Database from 1993 to 2005. We assessed associations between ambient solar UVR and dichotomized marker levels using adjusted weighted logistic regression models and applied a 5% false discovery rate criterion to P-values. UVR exposure was associated (P < 0.05) with 9 of the 78 markers. CCL27, CCL4, FGF2, GM-CSF, IFN-γ, soluble IL4R, IL-7, and IL-11 levels were lower with increasing UVR tertile, with adjusted ORs ranging from 0.66 to 0.80, and the significant association for CCL27 withstood multiple comparison correction. In contrast, CRP levels were elevated with increasing UVR. Solar UVR was associated with alterations in systemic immune and inflammation marker levels., Graphical abstract

Inulin clearance has, for a long time, been considered as the reference method to determine measured glomerular filtration rates (mGFRs). However, given the known limitations of the standard marker, serum creatinine, and of inulin itself, and the frequent need for accurate GFR estimations, several other non-radioactive (iohexol and iothalamate) and radioactive (51Cr-EDTA, 99mTc-DTPA, 125I iothalamate) exogenous mGFR filtration markers are nowadays considered the most accurate options to evaluate GFR. The availability of 51Cr-EDTA is limited, and all methods using radioactive tracers necessitate specific safety precautions. Serum- or plasma-based certified reference materials for iohexol and iothalamate and evidence-based protocols to accurately and robustly measure GFR (plasma vs. urinary clearance, single-sample vs. multiple-sample strategy, effect of sampling time delay) are lacking. This leads to substantial variation in reported mGFR results across studies and questions the scientific reliability of the alternative mGFR methods as the gold standard to evaluate kidney function. On top of the scientific discussion, regulatory issues are further narrowing the clinical use of mGFR methods. Therefore, this review is a call for standardization of mGFR in terms of three aspects: the marker, the analytical method to assess concentrations of that marker, and the procedure to determine GFR in practice. Moreover, there is also a need for an endogenous filtration marker or a panel of filtration markers from a single blood draw that would allow estimation of GFR as accurately as mGFR, and without the need for application of anthropometric, clinical, and demographic characteristics.

CLABSI is known to be one of the many healthcare-associated infections that has led to an increase in health complications, length of hospital stays, and increased in healthcare cost. There is about 25000 bloodstream infection that occurs annually (Haddadin, Annamaraju, & Regunath, 2020). The PICOT question that guided this project was “How does limiting blood-draw from central venous catheter lines influence the rate of central-line associated bloodstream infections (CLABSI) post-implementation compared to rate of CLABSI pre-implementation after eight weeks?” CLABSI prevention bundles were already being used to guide healthcare providers in handling CVC access. There were 15 scholarly articles that supports the use of bundle programs in CVC access and addressing CLABSI. The reduction in handling and manipulation of the CVC access leads to lesser risks of infection. The intervention in this project is the reduction of the CVC access through the limiting of blood draws from central lines with rare exceptions. CVC is primarily used only for the administration of intravenous fluids, antibiotic, parenteral nutrition, and blood products. The intervention utilized a structured decision-making framework to follow during blood draws to avoid using the central line. The project resulted to a reduction of CLABSI rate from 7.9% pre-implementation rate to 0% post-implementation. The limiting of CVC access led to reduced CLABSI episode in the telemetry unit compared to the national average of 5.94%. The project has proven how the intervention implemented can be used in CLABSI prevention bundles to address healthcare associated infections.

Young pediatric patients who undergo venipuncture or capillary blood sampling often experience high levels of pain and anxiety. This often results in distressed young patients and their parents, increased treatment times, and a higher workload for healthcare professionals. Social robots are a new and promising tool to mitigate children’s pain and anxiety. This study aims to purposefully design and test a social robot for mitigating stress and anxiety during blood draw of children. We first programmed a social robot based on the requirements expressed by experienced healthcare professionals during focus group sessions. Next, we designed a randomized controlled experiment in which the social robot was applied as a distraction method to measure its capacity to mitigate pain and anxiety in children during blood draw in a children’s hospital setting. Children who interacted with the robot showed significantly lower levels of anxiety before actual blood collection, compared to children who received regular medical treatment. Children in the middle classes of primary school (aged 6–9) seemed especially sensitive to the robot’s ability to mitigate pain and anxiety before blood draw. Children’s parents overall expressed strong positive attitudes toward the use and effectiveness of the social robot for mitigating pain and anxiety. The results of this study demonstrate that social robots can be considered a new and effective tool for lowering children’s anxiety prior to the distressing medical procedure of blood collection.

Liquid biopsy markers, which can be secured from a simple blood draw or other biological samples, are used to manage a variety of diseases and even monitor for bacterial or viral infections. Although there are several different types of liquid biopsy markers, the subcellular ones, including cell-free DNA, microRNA, extracellular vesicles, and viral particles, are evolving in terms of their utility. A challenge with liquid biopsy markers is that they must be enriched from the biological sample prior to analysis because they are a vast minority in a mixed population, and potential interferences may be present in the sample matrix that can inhibit profiling the molecular cargo from the subcellular marker. In this article, we discuss existing and developing analytical enrichment platforms used to isolate subcellular liquid biopsy markers, and discuss their figures of merit such as recovery, throughput, and purity.

Hematology is a common tool for wildlife health assessments. Manual leukocyte counts are required in reptiles, however, disagreement between quantification methods has been observed in some chelonians. This study determined agreement between two methods of leukocyte quantification, eosinophilic leukopet, and blood film white blood cell (WBC) estimates, in free-living eastern box turtles (Terrapene carolina carolina). Simultaneously, we assessed the impact of handling duration on both leukocyte quantity and corticosterone levels. We collected blood at capture (

The process of metastasis is characterized by the shedding of tumor cells into the bloodstream, where they are transported to other parts of the body to seed new tumors. These cells, known as circulating tumor cells (CTCs), have the potential to reveal much about an individual cancer case, and theoretically can aid in the prediction of outcomes and design of precision treatments. Recent advances in technology now allow for the robust and reproducible characterization of CTCs from a simple blood draw. Both the number of circulating cells and important molecular characteristics correlated with clinical phenotypes such as drug resistance can be obtained and used for real-time prognostic analysis. Molecular characterization can provide a snapshot of the activity of the main tumor (serving as a "liquid biopsy") and early warnings concerning changes such as the development of resistance, and aid in predicting the efficacy of different therapeutic approaches for treatment optimization. Herein, the authors review the current clinical use of CTCs as prognostic biomarkers for several different cancers. The quantification of CTCs can lead to more accurate staging and decision making regarding options such as adjuvant chemotherapy.

BACKGROUND Phlebotomy for diagnostic testing is among the commonest hospital procedures, but hospital-wide surveys of all inpatients characterizing blood draw volumes have not been published. The objectives were to characterize the daily blood volumes drawn for diagnostic testing from patients discharged from a Canadian tertiary care center, describe the daily distributions of phlebotomy volumes across service locations, and describe changes in hemoglobin (Hb) and transfusion across service locations. STUDY DESIGN AND METHODS Data were obtained on all patients discharged between 2012 and 2014 using linked discharge abstract and laboratory data. Cumulative daily blood volume and draw frequency were reported by service and days since admission. Changes in Hb and red blood cell (RBC) transfusion rates were reported for nontransfused and transfused patients. RESULTS Data were included on 59,715 subjects. Mean daily estimated blood loss varied from 8.5 ± 6.5 mL/day onward to 27.2 ± 20.0 mL/day in the intensive care unit (ICU; p

Introduction We investigated the relationship of plasma amyloid beta (Aβ) with cerebral deposition of Aβ and tau on positron emission tomography (PET). Methods Forty-four participants (18 cognitively normal older adults [CN], 10 mild cognitive impairment, 16 Alzheimer's disease [AD]) underwent amyloid PET and a blood draw. Free and total plasma Aβ40 and Aβ42 were assessed using a validated assay. Thirty-seven participants (17 CN, 8 mild cognitive impairment, 12 AD) also underwent a [18F]flortaucipir scan. Scans were preprocessed by standard techniques, and mean global and regional amyloid and tau values were extracted. Free Aβ42/Aβ40 (Aβ F42:F40) and total Aβ42/Aβ40 (Aβ T42:T40) were evaluated for differences by diagnosis and relation to PET Aβ positivity. Relationships between these measures and cerebral Aβ and tau on both regional and voxel-wise basis were also evaluated. Results Lower Aβ T42:T40 was associated with diagnosis and PET Aβ positivity. Lower plasma Aβ T42:T40 ratios predicted cerebral Aβ positivity, both across the full sample and in CN only. Finally, lower plasma Aβ T42:T40 ratios were associated with increased cortical Aβ and tau in AD-related regions on both regional and voxel-wise analyses. Discussion Plasma Aβ measures may be useful biomarkers for predicting cerebral Aβ and tau. Additional studies in larger samples are warranted.

Introduction Comprehensive genetic cancer profiling using circulating tumor DNA has enabled the detection of National Comprehensive Cancer Network (NCCN) guideline-recommended somatic alterations from a single, non-invasive blood draw. However, reliably detecting somatic variants at low variant allele fractions (VAFs) remains a challenge for next-generation sequencing (NGS)-based tests. We have developed the single-molecule sequencing (SMSEQ) platform to address these challenges. Methods The OncoLBx assay utilizes the SMSEQ platform to optimize cell-free DNA extraction and library preparation with variant type-specific calling algorithms to improve sensitivity and specificity. OncoLBx is a pan-cancer panel for solid tumors targeting 75 genes and five microsatellite sites analyzing five classes of NCCN-recommended somatic variants: single-nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), fusions and microsatellite instability (MSI). Circulating DNA was extracted from plasma, followed by library preparation using SMSEQ. Analytical validation was performed according to recently published American College of Medical Genetics and Genomics (ACMG)/Association for Molecular Pathology (AMP) guidelines and established the limit of detection (LOD), sensitivity, specificity, accuracy and reproducibility using 126 gold-standard reference samples, healthy donor samples verified by whole-exome sequencing by an external College of American Pathologists (CAP) reference lab and cell lines with known variants. Results were analyzed using a locus-specific modeling algorithm. Results We have demonstrated that OncoLBx detects VAFs of ≥ 0.1% for SNVs and indels, ≥ 0.5% for fusions, ≥ 4.5 copies for CNVs and ≥ 2% for MSI, with all variant types having specificity ≥ 99.999%. Diagnostic performance of paired samples displays 80% sensitivity and > 99.999% clinical specificity. Clinical utility and performance were assessed in 416 solid tumor samples. Variants were detected in 79% of samples, for which 87.34% of positive samples had available targeted therapy. Electronic supplementary material The online version of this article (10.1007/s40291-019-00406-0) contains supplementary material, which is available to authorized users.

WOS: 000471895800013 PubMed: 31203776 This study was conducted to find out the effects of different means of games used during pediatric blood draw on the levels of procedure-induced fear and anxiety. Patient descriptive information form and selected scales were completed for both the experimental and control group before the blood drawing procedure. During the blood draw procedure, the children in the experimental group listened to music and watched video games. Following the blood draw procedure, the children were given the Fear of Medical Procedure Scale and State Anxiety Inventory for a second time. The results of the study showed that differences between pre- and postprocedure average total scores of Fear of Medical Procedure Scale were statistically significant for all groups (p < .05). As a conclusion, it was found that making children listen to music or watch a video during blood draw was effective in decreasing their medical procedure fear levels and state anxiety.

To determine whether a 6-week Positivity Program could impact employee cardiovascular inflammation, blood sugars, cortisol, dehydroepiandrosterone (DHEA), and/or life satisfaction.Pre- and post-study blood draw and life satisfaction questionnaire tracked changes in 10 cardiovascular and inflammatory biomarkers for 63 employees who participated in a 6-week Positivity Program comprised of three interventions: gratitude, HeartMath's Heart Lock-In, and yoga stretches with guided imagery.Improvements were recorded in life satisfaction as well as in seven of 10 cardiovascular and inflammatory biomarkers, including high sensitivity C-reactive protein (HsCRP) (-27%), hemoglobin A1c (HbA1c) (-1%), glucose (-2%), myeloperoxidase (MPO) (-5%), lipoprotein-associated phospholipase-A2 (Lp-PLA2) (-9%), apolipoprotein B (ApoB) (-6%), and DHEA (1%). No improvements were recorded in cortisol (11%), small-dense LDL (sdLDL) (0%), or oxidized LDL (OxLDL) (7%).Data suggest that engaging in 6 weeks of a workplace Positivity Program may improve employee life satisfaction, blood sugar levels, and some markers of cardiovascular inflammation.

Introduction We examined the influence of common preanalytical factors on the measurement of Alzheimer's disease–specific biomarkers in human plasma. Methods Amyloid β peptides (Aβ[1-40], Aβ[1-42]) and total Tau plasma concentrations were quantified using fully automated Roche Elecsys assays. Results Aβ(1-40), Aβ(1-42), and total Tau plasma concentrations were not affected by up to three freeze/thaw cycles, up to five tube transfers, the collection tube material, or the size; circadian rhythm had a minor effect. All three biomarkers were influenced by the anticoagulant used, particularly total Tau. Aβ concentrations began decreasing 1 hour after blood draw/before centrifugation and decreased by up to 5% and 10% at 2 and 6 hours, respectively. For separated plasma, time to measurement influenced Aβ levels by up to 7% after 6 hours and 10% after 24 hours. Discussion Our findings provide guidance for standardizing blood sample collection, handling, and storage to ensure reliable analysis of Alzheimer's disease plasma biomarkers in routine practice and clinical trials., Highlights • Blood-based Alzheimer's disease biomarkers were measured with fully automated and highly precise Roche Elecsys assays. • Preanalytical sample handling affected measured concentrations of biomarkers. • Time between sample collection and centrifugation, and between centrifugation and measurement, impacted the measured concentrations of Aβ peptides. • Type of anticoagulant substantially affected measured levels of total Tau. • Recommendations for standardized sample collection and processing are provided.

Introduction Chronic posttraumatic stress disorder (PTSD) is associated with poor memory and increased burden of various degenerative cerebral neuropathologies. The goal of this pilot study was to determine whether PTSD was associated with changes in plasma-based neuropathological biomarkers of neurodegeneration among World Trade Center (WTC) responders. Methods Thirty-four WTC responders had blood drawn and flash-frozen within 15 minutes of retrieval. PTSD symptoms were assessed at that time. Age, sex, and WTC exposure duration were obtained from medical records. Plasma was assayed in duplicate using an ultra-sensitive single-molecule enzyme-linked immunosorbent assay to examine the distribution of amyloid-β (Aβ) 42/40 ratios, total Aβ, total tau, and neurofilament light (NfL). The comparison group was drawn from a bank of healthy controls collected and assayed at the same facility. Results The average age of WTC responders at blood draw was 53 years. Half were PTSD positive (PTSD+) as indicated by symptom severity. WTC responders had lower Aβ42/Aβ40 ratios but higher total tau and NfL levels in the plasma than healthy controls. PTSD+ status was associated with lower plasma Aβ load and higher Aβ42/Aβ40 ratios. Discussion Findings suggest that PTSD may be associated with alterations in plasma markers related to Aβ, tau, and NfL, highlighting the potential association between PTSD status and neurodegenerative neuropathology in WTC responders.

PURPOSE: Our main aim was to explore whether pre-diagnostic circulating levels of 25-hydroxyvitamin D (25(OH)D) among older individuals with cancer were associated with overall and cancer-specific survival after diagnosis. DESIGN: We used data from the Reykjavik-AGES Study on participants (n = 4,619) without cancer at entry, when blood samples were taken for 25(OH)D standardized measurements. The association with cancer risk, all-cause- and cancer-specific mortality was assessed among those later diagnosed with cancer, comparing four 25(OH)D categories, using 50–69.9 nmol/L as the reference category. RESULTS: Cancer was diagnosed in 919 participants on average 8.3 years after blood draw. No association was observed between the reference group and other 25(OH)D groups and total cancer incidence. Mean age at diagnosis was 80.9 (± 5.7) years. Of those diagnosed, 552 died during follow-up, 67% from cancer. Low pre-diagnostic levels of 25(OH)D < 30 nmol/L were significantly associated with increased total mortality (HR: 1.39, 95% CI 1.03, 1.88) and non-significantly with cancer-specific mortality (HR: 1.33, 95% CI 0.93, 1.90). Among patients surviving more than 2 years after diagnosis, higher pre-diagnostic 25(OH)D levels (≥ 70 nmol/L) were associated with lower risk of overall (HR: 0.68, 95% CI 0.46, 0.99) and cancer-specific mortality (HR: 0.47, 95% CI 0.26, 0.99). CONCLUSIONS: Among elderly cancer patients, low pre-diagnostic serum 25(OH)D levels (< 30 nmol/L) were associated with increased overall mortality.

Background: The stability of Alzheimer’s disease (AD) biomarkers in plasma, measured by immunomagnetic reduction (IMR) after long-term storage at –80°C, has not been established before. Method: Ninety-nine human plasma samples from 53 normal controls (NCs), 5 patients with amnestic mild cognitive impairment (aMCI), and 41 AD patients were collected. Each plasma sample was aliquoted and stored as single-use aliquots at –80°C. The baseline measurements for Aβ1–40, Aβ1–42, and total Tau protein (T-Tau) concentrations for each sample were done within 3 months of blood draw by IMR. They are referred to as baseline concentrations. A separate aliquot from each sample was assayed with IMR to assess the stability of the measured analytes during storage at –80°C between 1.1 and 5.4 years. This is referred to as a repeated result. Results: IMR shows that plasma levels of Aβ1–40 and Aβ1–42 exhibit stability over 5-year storage at –80°C and that plasma levels of T-Tau are less stable (approximately 1.5 years). Conclusion: Although the measured concentrations of T-Tau in human plasma may alter during storage, the diagnostic utility of the results are only slightly affected when the product of Aβ1–42 and T-Tau concentrations are used. The results show that the overall agreement between baseline and repeated measurements in the ability of discriminating NCs from aMCI/AD patients is higher than 80%.