Chemistry Panel Research Articles

Refining medical clearance protocol for patients with primary psychiatric complaints in the emergency department.

Medical clearance for patients with primary psychiatric complaints presenting to the emergency department has been debated for decades. Emergency physicians have argued that clearance labs are unnecessary, yet psychiatrists may still order or require them. A retrospective review was conducted to evaluate the continued need for labs of psychiatric patients and help identify high risk groups that may need additional intervention prior to medical clearance. Charts of 163 patients from Ochsner LSU Shreveport Psychiatric Crisis Unit (PCU) were reviewed with data collected of history, physical examination, review of systems, vitals and routine lab work including complete blood count (CBC), comprehensive metabolic panel (CMP), urine drug screen (UDS), serum ethanol level (EtOH), urinalysis (UA), creatine kinase (CK), urine pregnancy test (UPT), and rapid COVID-19. Review identified 82 patients (50.3%) that received interventions prior to medical clearance. Most common intervention was intravenous (IV) fluids (n = 59; 45%) followed by admission to other service (n = 15; 8.4%), imaging (n = 10; 7.6%), antihypertensive medication (n = 3; 3.1%), cardiac workup (n = 3; 2.3%), antibiotics (n = 3; 2.3%), lorazepam for undocumented reasons (n = 2; 1.5%). Additional interventions completed once included immunizations, antiseizure medication, pain medication, and additional lab work. Causes for IV fluids were reviewed with elevated creatine kinase (CK) (n = 31; 50.8%) being most common. Additional causes included undocumented (n = 12; 19.7%), tachycardia (n = 6; 9.8%), elevated EtOH level (n = 3; 4.9%), dehydration (n = 2; 3.3%), acute kidney injury (AKI) (n = 2; 3.3%), leukocytosis following a seizure (n = 1; 1.6%), elevated CK and leukocytosis (n = 1; 1.6%), and AKI and elevated CK (n = 1; 1.6%). Most common cause for medical admission was elevated CK being cited in 8 out of 15 admissions (53.3%). Additional causes for admission included AKI (n = 2; 14.3%), seizures and leukocytosis (n = 1; 6.7%), rule out of acute coronary syndrome (ACS) (n = 1; 6.7%), alcohol withdrawal (n = 1; 6.7%), encephalopathy with drop in hemoglobin and white blood cell count (n = 1; 6.7%), and encephalopathy with elevated CK (n = 1; 6.7%). Our results support the recommended guidelines set by AAEP for laboratory testing in addition to history, vital signs and physical examination prior to medical clearance. Certain laboratory testing such as CK and CMP were identified to have higher utility for medical intervention while other lab work such as UA and UDS had less of an impact. Further, we suggest that specifically a CK and CMP be obtained on patients presenting with any of the following: agitation, abnormal vital signs, intoxication, or a history of or current stimulant use as these were factors correlated with lab abnormalities that led to interventions.

Capillary blood stability and analytical accuracy of 12 analytes stored in Microtainers®

ObjectivesThe aim of this study was to determine feasibility of collecting capillary blood by traditional fingerstick and next day analysis after transport in Microtainers® at ambient temperature with no plasma separation. This study is pursuing an acceptable alternative to venipuncture for measuring 12 analytes important for health risk assessment. Designand Methods: Performance standards of a 12-assay chemistry panel were assessed using a set of paralleled serum and capillary microsamples. The panel included Hemoglobin A1c (HbA1c), Total Cholesterol, Triglycerides, HDL-C, Creatinine, Urea Nitrogen (BUN), Uric Acid, alkaline phosphatase (ALP), ALT (GPT), AST (GOT), gamma-glutamyltransferase (GGT), and total protein. Correlation studies were performed using 31 simultaneous venous and capillary blood collections. Analytical bias, correlation, and medical decision points were calculated to determine equivalency of sample type and the impact of transport conditions. Clinical sensitivity, specificity, and predictive values were evaluated at calculated medical decision points for their usability in health screening initiatives. ResultsLaboratory test results using capillary blood samples stored in Microtainers® under conditions of delayed centrifugation, and mail transport at ambient temperature, showed an acceptable agreement with results obtained using their paired serum samples analyzed using standard methods, except AST. ConclusionsCapillary blood samples can be self-collected at remote locations using Microtainers® and transported at ambient temperature for 24 h for successful performance of several medical tests important in large-scale health screenings programs.

Erythema nodosum A rare inflammatory disorder

Erythema nodosum is a rare inflammatory disorder that affects the subcutaneous fat layer. We present a case of a 32-yearold male patient who presented with painful nodules on his lower legs, associated with mild fever, malaise, and joint pain. Laboratory tests, including a complete blood count, comprehensive metabolic panel, and C-reactive protein, were within normal limits. A skin biopsy confirmed the diagnosis of erythema nodosum. The patient was started on a course of nonsteroidal anti-inflammatory drugs, and the nodules resolved over several weeks. This case highlights the importance of considering erythema nodosum in the differential diagnosis of a patient presenting with tender nodules on the lower legs and underscores the need for appropriate investigation to identify any underlying systemic cause

Passive sweat wearable: A new paradigm in the wearable landscape toward enabling "detect to treat" opportunities.

Growing interest over recent years in personalized health monitoring coupled with the skyrocketing popularity of wearable smart devices has led to the increased relevance of wearable sweat-based sensors for biomarker detection. From optimizing workouts to risk management of cardiovascular diseases and monitoring prediabetes, the ability of sweat sensors to continuously and noninvasively measure biomarkers in real-time has a wide range of applications. Conventional sweat sensors utilize external stimulation of sweat glands to obtain samples, however; this stimulation influences the expression profile of the biomarkers and reduces the accuracy of the detection method. To address this limitation, our laboratory pioneered the development of the passive sweat sensor subfield, which allowed for our progress in developing a sweat chemistry panel. Passive sweat sensors utilize nanoporous structures to confine and detect biomarkers in ultra-low sweat volumes. The ability of passive sweat sensors to use smaller samples than conventional sensors enable users with sedentary lifestyles who perspire less to benefit from sweat sensor technology not previously afforded to them. Herein, the mechanisms and strategies of current sweat sensors are summarized with an emphasis on the emerging subfield of passive sweat-based diagnostics. Prospects for this technology include discovering new biomarkers expressed in sweat and expanding the list of relevant detectable biomarkers. Moreover, the accuracy of biomarker detection can be enhanced with machine learning using prediction algorithms trained on clinical data. Applying this machine learning in conjunction with multiplex biomarker detection will allow for a more holistic approach to trend predictions. This article is categorized under: Diagnostic Tools > Diagnostic Nanodevices Nanotechnology Approaches to Biology > Nanoscale Systems in Biology Diagnostic Tools > Biosensing.

Serologic Evaluations in the Distinction Between Sinusitis-Related Orbital Cellulitis and Periorbital Necrotizing Fasciitis.

While sinusitis-related orbital cellulitis (SROC) and periorbital necrotizing fasciitis (PNF) share similar clinical presentations, they are managed differently, making rapid recognition of the appropriate clinical entity critical to optimal outcomes. This study was performed to assess whether serologic testing might help clinicians to distinguish between SROC and PNF. A retrospective review analysis was used to compare initial complete blood counts and comprehensive metabolic panels among adult patients with SROC and PNF. Statistical evaluations were used to determine the significance of differences between the groups. Thirteen patients with PNF and 14 patients with SROC were identified. The 2 groups were similar in age, gender, and likelihood of immunosuppression ( p > 0.05 for each metric). Mean leukocyte counts were 18.52 (standard deviation = 7.02) and 10.31 (standard deviation = 5.77) for PNF and SROC, respectively ( p = 0.0057). White blood cell levels were above normal limits for 12 patients with PNF (92.3%) and 7 patients with SROC (50%) ( p = 0.017). No other laboratory test was significantly different between the 2 groups. While the majority of serologic testing was quite similar in patients with either SROC or PNF, leukocyte levels may represent an important clue to distinguish between the two diseases. Clinical evaluation remains the gold standard to make the proper diagnosis, but markedly elevated white blood cell counts should prompt clinicians to at least consider a diagnosis of PNF.

831-P: Allogeneic Neo-Islets (NIs), an Immune-Privileged Cellular Therapy for T1DM, Is Safe and Effective in Spontaneously Diabetic Pet Dogs, Reducing Insulin Need by up to 50% over Three Years

The purpose of this INAD pilot study was to assess the safety, feasibility and efficacy of NIs in significantly reducing or eliminating a T1DM dog's need for insulin and/or preventing, halting or reversing DM-related damage to a dog's other organs. NIs (3-D organoids made of Mesenchymal Stromal Cells (MSCs) and cultured, partially dedifferentiated islet cells) have been shown preclinically (NOD mouse model) to eliminate the need for exogenous insulin when introduced i.p. Their MSC component provides immune isolation, allowing their allogeneic use without antirejection agents. Hypothesis: Allogeneically administered NIs would safely, durably, and significantly reduce or eliminate the need for exogenous insulin in spontaneously T1DM dogs, as was found in experimental mice. 6 (4 M, 2 F) spontaneously DM, pet dogs; age 1-12 years were treated under INAD 012-776 and followed 3 years. 2×10e5 NIs/kg bw were introduced under ultrasound guidance to metabolically controlled (blood glucose, triglycerides, thyroid, adrenal functions), sedated animals. Dogs were maintained on insulin as needed, and were followed clinically (CBCs, Chemistry panels, Urinalyses, physical examination, imaging, endocrine function) by the PIs and the dogs’ regular veterinarians. Results: Over 3 years, daily insulin needs, blood and urine glucose and fructosamine fell significantly in 5 of 6 dogs; renal function, body weights, CBCs, chemistries were unchanged. Urinary protein decreased; no hypoglycemic events, and immune response to NIs were observed; no AEs or SAEs were attributed to NIs. Redosing and dosing strategies are being tested to try to eliminate exogenous insulin need. Allogeneic NIs are safe and durably effective, and has significant translational relevance. Even partial effectiveness protects from end-organ damage and preserves renal function. A successful Pre-IND meeting for NI use in humans has been held. Disclosure A.Gooch: Board Member; SymbioCellTech, LLC, Employee; SymbioCellTech, LLC, Stock/Shareholder; SymbioCellTech, LLC. C.Westenfelder: Board Member; SymbioCellTech, LLC., Employee; SymbioCellTech, LLC., Research Support; SymbioCellTech, LLC., Stock/Shareholder; SymbioCellTech, LLC.

The impact of both-bone forearm fractures on acute compartment syndrome: An analysis of predisposing factors

ObjectivesAcute compartment syndrome (ACS) is a severe medical condition that, if left untreated, can cause permanent nerve and muscle damage, and may even require amputation. The objective of this study was to identify the risk factors associated with the development of ACS in patients with both-bone fractures of the forearm. MethodsBetween November 2013 and January 2021, a retrospective data collection was conducted on 611 individuals who experienced both-bone forearm fractures at a level 1 trauma center. Among these patients, 78 patients were diagnosed with ACS, while the remaining 533 patients did not have ACS. Based on this division, the patients were categorized into two groups: the ACS group and the non-ACS group. Demographics (including factors such as age, gender, body mass index, crush injury, etc.), comorbidities (including conditions such as diabetes, hypertension, heart disease, anemia, etc.), and admission lab results (including complete blood count, comprehensive metabolic panel, and coagulation profiles, etc.) were analyzed using univariate analysis, logistic regression, and ROC curve analysis. ResultsPredictors of ACS were identified through the final multivariable logistic regression analysis, which revealed that crush injury (p < 0.001, OR = 10.930), the levels of neutrophils (NEU) (p < 0.001, OR = 1.338) and the levels of creatine kinase (CK) (p < 0.001, OR = 1.001) were significant risk factors. Additionally, age (p = 0.045, OR = 0.978) and albumin (ALB) level (p < 0.001, OR = 0.798) were found to provide protective effects against ACS. Furthermore, the receiver operating characteristic (ROC) curve analysis determined cut-off values for NEU and CK to predict ACS: 7.01/L and 669.1 U/L respectively. ConclusionsOur study identified crush injury, NEU, and CK as significant risk factors for ACS in patients with both-bone forearm fractures. We also determined the cut-off values of NEU and CK, allowing for the individualized evaluation of ACS risk and the implementation of early targeted treatments.

The relationship between troponin T and plaque burden in patients with stable chest pain

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Certain laboratory parameters of patients presenting with stable chest pain may also have clinical utility in estimating individual cardiovascular (CV) risk in addition to ruling out acute myocardial infarction. Therefore, it is plausible that they provide valuable information on the overall plaque burden in patients with low to intermediate CV risk who are examined due to suspected coronary artery disease (CAD). Purpose Our purpose was to investigate the potential association of certain laboratory parameters of potential cardiological relevance and the extent and severity of CAD, as assessed by coronary CT angiography (CCTA). Methods In our present study, 307 consecutive patients referred to CCTA due to suspected CAD were enrolled. A comprehensive laboratory panel (including a complete blood count, comprehensive metabolic panel, lipid panel, cardiac biomarkers, and C-reactive protein) was performed immediately before the CCTA for all patients. Segment stenosis score (SSS) was calculated on CCTA images to characterize overall plaque burden. A score was assigned to each coronary segment according to the most severe stenosis present: &amp;lt;25%: 1 point, 25–49%: 2 points, 50–69%: 3 points, ≥70: 4 points. The patient's SSS score was calculated as the sum of each score. Predictors of SSS were determined by linear regression analysis incorporating traditional CV risk factors and laboratory parameters. Results The mean age of the patients was 57.1 ± 11.5 years, 65% (200/307) had CAD. The independent predictors of SSS were female sex (ß = −1.63 [95%CI: −2.28–−0.98], p&amp;lt;0.001), age (ß = 0.08 [95%CI: 0.05–0.16], p&amp;lt;0.001), alcohol consumption (ß = 0.26 [95%CI: 0.06–0.47], p = 0.01), hypertension (ß = 0.70 [95%CI: 0.07–1.33], p = 0.03), blood glucose level (ß = 0.40 [95%CI: 0.05–0.75], p = 0.03), and troponin T level (ß = 0.08 [95%CI: 0.006–0.16], p = 0.03). Conclusions The elevation of troponin T in patients with stable angina was independently associated with SSS, which might be due to subclinical plaque ruptures causing myocardial injury. The measurement of troponin T may allow more precise risk stratification of patients with stable angina.

#4486 VALIDATION OF A CKD PROGRESSION RISK PREDICTION MODEL IN THE FIDELITY TRIAL POPULATION

Abstract Background and Aims Chronic kidney disease (CKD) is often underrecognised until later stages when most of the kidney function is lost and the therapeutic window for disease-modifying therapy is narrow [1]. We previously developed a lab-based risk prediction model to accurately predict CKD progression in adults at all stages of CKD [2]. Here, we describe a validation of our model in the clinical trial population of FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) trials for the nonsteroidal mineralocorticoid receptor antagonist finerenone [3]. Method We performed a post hoc analysis of all participants from the FIDELITY database, irrespective of estimated glomerular filtration rate (eGFR) or albuminuria stage. Baseline values for the underlying laboratory tests required for the model, Klinrisk, were extracted from the complete blood count, comprehensive metabolic panel and urine albumin-to-creatinine ratio (UACR). The predicted outcome was a ≥40% decline in eGFR or kidney failure. We calculated discrimination ability of the model and calibration using area under the curve (AUC), Brier scores and calibration plots in the overall population, and stratified by treatment assignment. Sensitivity analyses examined the accuracy of the models in predicting ≥57% decline in eGFR, as well as the change in risk score over time. Kidney Disease: Improving Global Outcomes (KDIGO) heat map categories were used as the reference standard. Results We included 13,026 participants with a mean age of 64.8 ± 9.5 years, mean eGFR of 57.6 ± 21.7 ml/min/1.73 m2, and median UACR of 58.2 mg/mmol (interquartile range 22.4–129.6). At time horizons of 2 and 4 years, 984 and 1795 patients experienced a primary outcome event, respectively. The Klinrisk model predicted progression accurately, with an AUC of 0.81 (95% confidence interval [CI] 0.79–0.82) at 2 years and 0.86 (95% CI 0.84–0.87) at 4 years, compared with the KDIGO heatmap categories (AUC of 0.59 [95% CI 0.58–0.60] at 2 years and 0.66 [95% CI 0.65–0.68] at 4 years). Calibration was appropriate (Brier score of 0.067 [95% CI 0.064–0.070] at 2 years and 0.115 [95% CI 0.109–0.120] at 4 years). Similar discrimination accuracy was seen for the ≥57% decline outcome (C-statistic 0.88, 95% CI 0.87–0.90) at 3 years. Conclusion Based on routinely collected lab data, our machine learning model (Klinrisk) accurately predicts CKD progression events in a well characterized global clinical trial population. Prospective implementation of the model in clinical trial enrolment as well as clinical care pathways is needed.

Atrial fibrillation induced by gabapentin: a case report

BackgroundGabapentin is commonly prescribed for the treatment of neuropathic pain, restless leg syndrome, and partial-onset seizures. Although the most frequent side effects of gabapentin are associated with the central nervous system, gabapentin can also affect the cardiovascular system. Case reports and observational studies have showed that gabapentin can be associated with increased risk of atrial fibrillation. However, all the evidence is concentrated in patients older than 65 years old with comorbidities that predispose them to the development of arrhythmias.Case presentationWe describe a case of an African American male in his 20s that presented to our chronic pain clinic with lumbar radiculitis and developed atrial fibrillation 4 days after being started on gabapentin. Laboratory workup did not show significant abnormalities, including normal complete blood count, comprehensive metabolic panel, toxicology screen, and thyroid-stimulating hormone. Transthoracic and transesophageal echocardiography showed a patent foramen ovale with right-to-left shunt. The patient was initially treated with diltiazem for heart rate control and apixaban. Direct current cardioversion with successful conversion to sinus rhythm was performed 24 hours after admission. The patient was then discharged on apixaban and diltiazem. Apixaban was changed to low-dose aspirin 1 month after discharge.ConclusionWith rapidly increasing usage of gabapentin for approved and off-label indications, it is important to identify unintended adverse effects of this drug as they are considered safe alternatives to opioids. New-onset atrial fibrillation could be induced by gabapentin in young individuals.

Neonatal Salmonella Meningitis With Subdural Empyema: A Case Report.

To the Editors: Salmonella species can cause a variety of neonatal infections which are most prevalent in sub-Saharan Africa. Salmonella meningitis is associated with long-term neurologic sequelae1 including seizures, hydrocephalus, subdural effusions, empyema, ventriculitis, hemorrhage and abscess.2 The present case describes a neonate with Salmonella meningitis with subdural empyema. A 12-day-old full-term female presented to the emergency department for a 1-day history of fever, decreased feeding, and a shorter, gasp-like breathing pattern. The baby was tachycardic and febrile. Per patient’s mother, both she and the infant’s brother were suffering from diarrhea 3 days before onset of the infant’s symptoms. A full sepsis workup was initiated, including blood, urine and cerebrospinal fluid cultures. The patient was empirically started on intravenous ampicillin and gentamicin pending culture results. Additionally, a respiratory pathogen panel via polymerase chain reaction performed on the same day indicated positive results for coronavirus disease 2019 (COVID-19). The patient was admitted for further management of presumed neonatal sepsis and respiratory monitoring of COVID-19 infection. The patient was subsequently found to have positive blood culture and cerebrospinal fluid gram stain for Gram-negative rods. Speciation and sensitivities later grew Salmonella species with sensitivity to ampicillin and ceftriaxone. Magnetic resonance imaging of the brain was significant for diffuse right leptomeningeal enhancement consistent with meningitis and subdural empyema. No neurosurgical intervention was recommended. Ampicillin and gentamicin were discontinued after 3 days of treatment, and ceftazidime was started for treatment of salmonella meningitis. Ceftriaxone was considered as the standard treatment for invasive Salmonella infection, but was inappropriate due to mildly elevated bilirubin on admission (Table 1) and patient’s age. TABLE 1. - Admission Labs Complete blood count With Differential Day 1 of Admission White blood cell count 6.4 × 103/µL Hemoglobin/hematocrit 12.6/37.3 g/dL Platelets 564 × 103/µL Segmented neutrophils 40% Bands 24% Lymphocytes 26% Monocytes 7% Urinalysis Color Dark yellow Specific gravity 1.021 pH 7.0 Protein 2+ Glucose Trace Ketones Negative Bilirubin Negative Blood Negative Nitrites Negative Urobilinogen 0.2 Leukocyte esterase 2+ Urine microscopy White blood cells >50 Red blood cells 11.1 Squamous epithelial 5.3 Bacteria 40 Casts 3.9 Chemistry Sodium 138 mmol/L Potassium 4.1 mmol/L Chloride 107 mmol/L Bicarbonate 22 mmol/L Blood urea nitrogen/creatinine 8/0.37 mg/dL Glucose 108 mg/dL Total bilirubin 9.6 mg/dL Total protein 6.2 g/dL Albumin 3.1 g/dL Alanine transaminase/aspartate transaminase 18/23 Units/L Alkaline phosphatase 143 Units/L Cerebrospinal fluid Color Cloudy White blood cells 667 cu/mm Red blood cells 42,500 cu/mm Segmented neutrophils 90% Lymphocytes 8% Monocytes 1% Eosinophils 1% Basophils 0% Inflammatory markers C-reactive protein (admission) 3.06 mg/dL C reactive protein (hospital day #2) 25 mg/dL On the third day of admission, a repeat respiratory pathogen panel showed the patient to be COVID-19 negative, and it was concluded that the initial positive test was likely a false positive. Repeat blood cultures drawn on day 4 of admission were negative. On day 8 of admission, a peripherally inserted central catheter line was placed for long-term parenteral antibiotics. On day 10 of admission, ceftazidime was discontinued and switched to ceftriaxone after a repeat complete metabolic panel showed normalized bilirubin levels. Ceftriaxone was selected (in lieu of ampicillin) to minimize peripherally inserted central catheter line access thereby reducing probability of central line–associated bacterial infection. Inflammatory markers and bilirubin were trended closely due to use of ceftriaxone. A 6-week course of treatment was completed with no further complications and improvement of radiologic findings. The patient was discharged with no apparent neurological deficits. Her development was ascertained by phone call and the child continues to develop typically. Previous case reports indicate that third generation cephalosporins are ideal for management of salmonella meningitis due to their bactericidal properties.3,4 This case offers a suggested treatment course of neonates with transition from ceftazidime to ceftriaxone showing satisfactory results in the treatment of neonatal Salmonella sepsis and meningitis complicated by empyema. ACKNOWLEDGMENTS The authors thank the patient and family for their participation in this report.

Incidence of hypomagnesemia in patients with HER2+ breast cancer treated with pertuzumab.

e12569 Background: Breast cancer is the most common cancer diagnosed in women. HER2 gene amplification/protein overexpression is seen in about 20% of breast cancer cases. Pertuzumab (P), an EGFR inhibitor, is a monoclonal antibody administered with Trastuzumab in the treatment of HER2-positive breast cancer. Breast oncologists across multiple institutions have noted hypomagnesemia in patients receiving P-containing regimens. Retrospective data from Memorial Sloan Kettering Cancer Center and University of Florida Health have reported the incidence of hypomagnesemia in patients treated with P neoadjuvantly (8/90 and 7/25, respectively). Cetuximab and Panitumumab, also EGFR inhibitors, are well known to cause hypomagnesemia. Hypomagnesemia can be clinically associated with convulsions, atrial tachycardias, hypocalcemia and hypokalemia. This prospective study details the incidence, severity, and timeline of hypomagnesemia in HER2-positive breast cancer patients treated with P. Methods: 27 eligible patients were identified at two institutions through medical oncology clinic visits and weekly tumor board screenings. Inclusion criteria was HER2+ breast cancer patients initiating treatment with P. Patients receiving platinum agents were excluded (8/27). Following informed consent, magnesium levels were obtained along with standard of care comprehensive metabolic panels at the first four P infusions (19/27). Results: A one-sample binomial test was used to compare the proportion of hypomagnesemia at 3 months among subjects who receive P with 2% (historical control). Results demonstrated that only one patient developed a magnesium level below normal range, resulting in no significant difference with historical control (P = 0.291) This patient’s magnesium level was low at baseline and did not significantly improve or worsen throughout treatment with P. Conclusions: There was no significant incidence of hypomagnesemia noted in HER2+ breast cancer patients treated with P. This emphasizes the safety of P in patient populations prone to developing hypomagnesemia such as those receiving concurrent Carboplatin. Our results do not indicate clinical monitoring of hypomagnesemia is necessary for patients receiving P. [Table: see text]

0614 Characterizing Sleep in Early-Morning Shift Workers at Risk for Shift Work Disorder

Abstract Introduction Shift work is increasingly common in our 24/7 society and can cause sleep disturbances and excessive sleepiness. Roughly 10-43% of shift workers are diagnosed with shift work disorder (SWD), characterized by excessive sleepiness accompanied by reduced sleep duration and/or insomnia. While more individuals work early morning shifts (shift start 3-6AM) compared to overnight shifts, few studies have investigated this population. The aim of this study was to characterize sleep in a population of early-morning shift workers. Methods We characterized sleep in early-morning shift workers (18-65yrs) from New England who were screened for a clinical trial of a wake-promoting agent. Pre-screening consisted of the Epworth Sleepiness Scale (ESS) and a Shift Work Disorder Questionnaire (SWD); screening consisted of the Pittsburg Sleep Quality Index Questionnaire Questionnaire (PSQI) ; a physical exam including an ECG, CBC, urinalysis, and comprehensive metabolic panel; a home sleep test (HST), a Monitored Wakefulness Test (MWT); a physician evaluation of their excessive sleepiness (Clinical Global Impression [CGI]); and a self-evaluation regarding how sleepiness affected their everyday life (Patient Global Impression [PGI]). Only data from consented individuals who met the initial inclusion criteria of being high risk for SWD were included in the analysis. Results 158 early-morning shift workers met the pre-screening criteria and began the screening process. Most worked in retail, healthcare, maintenance, or transportation, and worked five shifts (65%) and 40+ hours (72%) per week, with a duration of 8.8±1.9 hours. 41 were screened out for abnormal findings on the PE, ECG, or screening blood/urine tests; 26 were screened out for previously un-diagnosed OSA or PLMD; 4 were ineligible for other reasons; 7 were excluded after their MWT due to long sleep latency, 20 were lost to follow-up/withdrew and 60 completed screening and met inclusion criteria. Their average (±sd) age was 37±11 years, 45% women, PSQI score 7.5±2.7, sleep duration 5.6±1.0, ESS=16.3±3.1, CGI=4.2±0.9, PGI=3.6±1.1. Conclusion Early-morning shift workers at an increased risk for SWD report short and disturbed sleep, excessive sleepiness, and a negative impact of sleepiness on their quality of life. Many have undiagnosed OSA and PLMD. Support (if any) Axsome Therapeutics, Jazz Pharmaceuticals, Brigham and Women’s Hospital Center for Clinical Investigation.

Evaluating the utility of perioperative laboratory tests in primary shoulder arthroplasty

BackgroundThe rising incidence of primary total shoulder arthroplasty (TSA) predicts a $4 billion increase in cost associated with this procedure by 2030. Studies have evaluated sources of cost containment, including inpatient services, namely routine perioperative laboratory tests. This study evaluates the utility of routine perioperative complete blood count (CBC) and basic metabolic panel (BMP) in TSA and identifies predictors of abnormal postoperative laboratory results and the need for medical intervention (NMI). MethodsAll patients undergoing primary TSA from 2013 to 2020 at a single institution were included. Demographics, comorbidities, procedural details, and preoperative and postoperative CBC and BMP values were recorded. Abnormal values were identified for each laboratory parameter. NMI was defined as postoperative blood transfusion, electrolyte repletion, fluid resuscitation, and inpatient medical consultation. Univariate and multivariate analyses were performed to determine independent predictors for abnormal postoperative CBC and BMP (AbBMP) results and NMI. A P value < .05 was considered statistically significant. ResultsA total of 328 patients were included in the study, with 202 (61.6%) female patients and a median age of 70.5 years. Medical intervention was required in 115 (35.1%). There were no differences in rates of NMI based on patient demographics, comorbidities, and preoperative CBC and BMP results, although there was a significant difference in rates of NMI when comparing postoperative serum potassium (4.1 mmol/L in no NMI group; 3.9 mmol/L in NMI group; P = .039). Ultimately, there were no demographic, surgical, or laboratory factors associated with postoperative NMI on predictive modeling. Increasing body mass index (odds ratio [OR] 1.08, 95% confidence interval [CI] 1.01-1.15, P < .03), preoperative serum glucose (OR 1.05, 95% CI 1.02-1.08, P = .003), and preoperative serum blood urea nitrogen (OR 1.12, 95% CI 1.05-1.12, P = .01) are associated with an 8.0%, 5.0%, and 12% increase in odds of an AbBMP, respectively. Preoperative potassium is inversely correlated with odds of AbBMP (OR 0.19, 95% CI 0.05-0.67, P = .01). ConclusionsAlthough postoperative laboratory tests were routinely obtained following primary shoulder arthroplasty, abnormal postoperative CBC and BMP were not associated with NMI. Postoperative BMP tests should be considered in patients with elevated body mass index, elevated preoperative serum glucose, elevated preoperative serum blood urea nitrogen, and those with preoperative serum hypokalemia. Postoperative CBC tests are likely not necessary after primary shoulder arthroplasty.

85 Evaluation of an Oral Supplemental Cannabidiol Product for Acceptability in Mature Horses

Abstract Thirty stock type geldings (15 ± 3 y; 556 ± 63 kg BW) were used in a randomized complete design for a 28-d trial to evaluate the influence of cannabidiol (CBD) oil supplementation on health of mature horses by conducting a blood chemistry panel and evaluating the presence of banned substances. Horses were stratified by BW and age, and randomly assigned to 1 of 3 dietary treatments formulated with canola oil to provide.50 mg CBD/kg BW (TRT1; n = 10), 0.75 mg CBD/kg BW (TRT2; n = 10), or 0.00 mg CBD/kg BW (canola oil; CON; n = 10) only as determined by manufacturer (Arrowhead Labs). Treatments were individually fed and top-dressed onto a commercially available concentrate twice daily at 12 h intervals using attachable feed bags. Diets were formulated to meet or slightly exceed nutritional requirements for mature horses at maintenance. Between meals, horses were maintained in adjacent dry lots and received coastal bermudagrass hay ad libitum. Body weight was obtained, and body condition scores (BCS) were assigned every4 d. On d 0 and 28, blood was collected via jugular venipuncture and serum was harvested to perform a blood chemistry panel and drugs of abuse screening at the Texas Veterinary Medical Diagnostic Laboratory (TVMDL; College Station, TX). Data were analyzed using PROC MIXED of SAS (v9.4), and the model included treatment, time, and the treatment × time interaction for BW and BCS. Blood chemistry variables on d 0 were used as a covariate and the main effect tested was treatment. Linear and quadratic orthogonal polynomial contrasts were used to partition sum of squares. Analysis of supplement samples revealed supplemented products contained lower CBD concentrations then indicated from initial testing. Therefore, horses in TRT1 and TRT2 received an average of 0.13 mg CBD/kg and 0.12 mg CBD/kg BW, respectively. Dietary treatments did not affect concentrate intake, BW, or BCS. Supplementation of CBD did not result in the presence of any banned substances in serum, including CBD, 7-carboxycannabidiol, 7-Nor-7-carboxycannabidiol, and tetrahydrocannabinol (THC). Following 28 d of supplementation, gamma-glutamyl transferase (GGT) responded quadratically (P = 0.06) to treatment, with a peak in GGT in horses receiving TRT2. Serum creatinine concentration tended (P = 0.06) to decrease with increasing inclusion of CBD in the diet. In contrast, the main effect of treatment on Ca concentrations was linear (P = 0.01) and characterized by decreased Ca values for TRT1 compared with TRT2 and CON. Canola based CBD oil was well-accepted by mature horses, banned substances were not detectible in blood, and blood chemistry parameters were not adversely affected as a result of supplementation; however, more information is needed to improve stability of CBD used in dietary products.

63 Influence of diet and body condition on blood chemistry and body composition during the refeeding process

Starved horses with low body condition scores (BCS, < 3 out of 9) continues to be a prominent welfare concern, yet limited nutritional studies on the reconditioning process exist. The aim of this study was to determine how alternative diets affected blood chemistry panels and body composition in mature, starved (initial BCS 1 or 2) light breed horses during the refeeding process (final BCS 4, UTK IACUC 2811–1220). Horses (n = 10, 18.8 ± 2.5 y (mean ± SD), BCS 1.4 ± 0.5, 3 geldings and 6 mares, light breeds) were placed on a control diet (C; 100% digestible energy, DE, from grass hay and Purina Free Balance) or a concentrate diet (S; 50 % DE from grass hay and 50% DE from Purina Equine Senior). Diets were formulated to increase caloric intake in accordance with previously established refeeding recommendations and the NRC (2007), where horses were increased from 50% DE to 100% DE over 10 d to prevent refeeding syndrome, and then were increased up to 145% DE as needed based on weekly body weight (BW) until a BCS of 4 was reached. Weekly BW and BCS were assessed by 3 independent reviewers and plasma samples collected at each BCS increase based on reviewer average and an increase in of 16–20 kg in BW. Diet and BCS effects on blood chemistry and body composition were analyzed using generalized linear mixed models in SAS, with breed and individual animals as random effects, and mean separation using Tukey's adjustment.Significance was detected at P < 0.05 (SAS 9.4, Cary, NC). Non-normally distributed data were rank transformed as determined by Shapiro-Wilk. Of the 10 horses in the study, 3 were euthanized within 10d of enrollment due to infectious disease or colic unassociated with dietary treatment, 1 was disenrolled due to pneumonia, and the remaining 6 horses were fully reconditioned (C: n = 3, S: n = 3). Horses were recovered similarly between diet groups (change in BW: C = 46.15 ± 9.9 kg, S = 41.8 ± 14.9 kg, mean ± SD, P > 0.05). Plasma creatine kinase differed by BCS (P = 0.0007), whereas creatinine differed by both diet (P = 0.006) and BCS (P < 0.0001); however, all values were within normal limits. Lactose was lower in BCS 4 horses compared with all other scores, yet all values were also within normal ranges (P = 0.0007). Rib fat thickness was greater in BCS 4 horses (C = 0.35(0.08)mm, S = 0.38(0.20)mm, median(IQR)) than all other BCS (P = 0.001). Rump fat thickness was highest in BCS 4 horses (S = 0.36 (0.13), C = 0.30 (0.05)). Based on our findings, grass hay and complete feed concentrates can be used to successfully recover emaciated horses. Further studies would be helpful in determining optimal refeeding protocols.

Curious Cases of Painful Ophthalmoplegia (P1-9.012)

<h3>Objective:</h3> Importance of various investigations for diagnoses by exclusion and importance of starting treatment, which might be common for specific pathologies irrespective of different etiologies. (in a resource-limited environment) <h3>Background:</h3> There were two cases of adult women (Patient G and Patient V) residing in the same neighborhood. They presented with similar complaints of right-sided orbital pain, headache, and sixth cranial nerve palsy. <h3>Design/Methods:</h3> On individual evaluation, Patient G had prominent right-sided dull orbital pain for 3 weeks with right-sided headache and diplopia for 1 week. Examination showed ipsilateral sixth nerve paresis. Investigations like Complete Blood Count, Complete Metabolic Panel, Chest X-ray, ANA, CSF Analysis (including Adenosine deaminase), ESR, and CRP were negative. MRI showed a single hypointense extra-axial lesion in right anteromedial temporal region, anterolateral to ipsilateral cavernous sinus. The lesion appeared to partially encase right sixth cranial nerve and approaching right superior orbital fissure. Patient V had similar complaints of right-sided headache for 4 weeks and diplopia for 1 week. Examination showed complete paralysis of ipsilateral sixth nerve palsy. Similarly, investigations were negative (including serum ACE levels). MRI revealed a single extra-axial hypointense lesion along right medial temporal region along with partial invasion of ipsilateral cavernous sinus. Mild asymmetric thickening of right fifth and sixth cranial nerves was seen. <h3>Results:</h3> Investigations were necessary to rule out differential diagnoses like tuberculous meningoencephalitis, thyroid ophthalmopathy, and other infectious, autoimmune, or neoplastic etiologies. By diagnosis of exclusion, patient G was diagnosed with <b>Tolosa-Hunt syndrome</b>. Though biopsy results were unavailable for patient V, she was provisionally diagnosed with <b>Neurosarcoidosis</b>. Both were started on Corticosteroids. On respective follow-up visits, both patients reported significant improvement in their symptoms. This further solidified the respective diagnoses in these patients. <h3>Conclusions:</h3> In a resource-limited environment, response to treatment is as important as other investigations to diagnose rare diseases by exclusion. <b>Disclosure:</b> Mr. Shah has nothing to disclose.

Abstract LB004: Ultra-sensitive targeted DNA panel for very low-frequency mutation detection in circulating cell-free DNA

Abstract Due to its noninvasive nature and being readily available in peripheral blood and other bodily fluids, analysis of cell-free DNA (cfDNA) has become a promising application in cancer diagnosis, prognosis and treatment monitoring. However, disease-relevant cfDNA is present in a very limited amount in the huge background of normal cfDNA. This remains a challenge for any detection technology. Many currently available target enrichment and library preparation methods use regular DNA polymerase and amplification processes that introduce substantial bias and artifacts. This results in artifactual errors that greatly limit the detection of true low-frequency variants below 0.5% in heterogeneous samples, such as cfDNA. Here, we present a new targeted cfDNA workflow that overcomes challenges such as biases and artifacts. The workflow uses a highly optimized, high-fidelity reaction chemistry and incorporates UMIs into a single gene-specific, primer-based targeted enrichment process. Compared to regular DNA polymerase, this high-fidelity chemistry resulted in a five- to ten-fold decrease in base substitution error. An individual cancer panel was designed to specifically cover cancer-relevant hotspots and copy number genes with a dense primer design to accommodate the short length of cfDNA. Due to its high-fidelity chemistry and optimal panel design, our streamlined workflow can be completed in a single day. We also report consistent panel performance across different samples. Detection sensitivity and specificity were evaluated on a reference cfDNA sample and a simulated cfDNA sample by mixing enzyme-digested Genome in a Bottle samples, NA12878 and NA24385. We achieved close to 90% detection sensitivity and above 99.9% specificity for 0.1% variant. In addition, copy number variation could be successfully detected with a 1.5-fold difference over normal control samples. These results demonstrate an efficient targeted cfDNA panel workflow that enables cancer-relevant mutation detection with high sensitivity and accuracy. The applications presented here are for research use only. Not for use in diagnostic procedures. Citation Format: Michelle Baird, Mariam Ashraf, Emil Chistensen, Christa Haldrup, Zhong Wu, Eric Lader. Ultra-sensitive targeted DNA panel for very low-frequency mutation detection in circulating cell-free DNA [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr LB004.

Descriptions and Changes in Charge Master Pricings of US Children’s Hospitals From 2019 to 2021

A lack of price transparency may contribute to high healthcare costs. US hospitals were mandated to post their charge masters online in 2019. To compare changes in charge master prices of 3 common tests (complete blood count, complete metabolic panel, and chest radiograph) at US children's hospitals between 2019 and 2021. Online search for charge master was conducted from July to December 2019 and October to December 2021. Descriptive statistics were reported for each test. Prices between years were adjusted for inflation and compared with paired t test. City-level variation was evaluated by comparing the coefficient of variation in 6 metropolitan areas: Baltimore, California Bay Area, Chicago, Dallas-Fort Worth, Los Angeles, and New York City. Of 847 hospitals, charge masters were found in 747 (88%) in 2021 and 728 (86%) in 2019. Complete blood count prices ranged from $5 to $1037 in 2019 and $5 to $1085 in 2021, with no difference between the 2 years (P = .17). Complete metabolic panel prices ranged from $10 to $2440 in 2019 and $6 to $2746 in 2021, with no difference in prices (P = .75). Chest radiograph prices ranged from $20 to $1900 in 2019 compared with $30 to $5800 in 2021. Prices were higher compared with 2019 ($392 vs. $365, P < .0006). City-level changes in the coefficient of variation showed only 2 cities with reduced coefficients of variation in all 3 tests. Two years after mandating hospitals post charge masters online, there continues to be tremendous variability in prices of common tests across US children's hospitals.

Opportunities for recycling in an automated clinical chemistry laboratory produced by the comprehensive metabolic panel.

Clinical laboratories perform a variety of tests for which biomedical waste is a byproduct. Of these, the complete metabolic panel (CMP) produces a significant portion of this waste. We investigated specific waste subsequent to performing CMPs over the course of a year and analyzed what percentage of the waste produced could have been recycled. Patient testing volumes were collected retrospectively from July 14, 2021, to July 14, 2022, for individual assays within the CMP performed on Abbott Alinity c instruments (n = 6). The average weights for components of the reagent kits, which includes wedges, boxes, and package inserts, were calculated. These weights, in conjunction with total patient testing volumes, were used to determine the amount of waste produced. A total of 1089.2 kg of reagent kit waste was estimated to be produced by performing CMPs throughout a year. Of this waste, most (855.5 kg) was not recyclable, but a subset (233.6 kg) was. Overall, 21.4% of the total specific waste weight was found to be recyclable. The CMP contributes a substantial amount of waste when performed on chemistry analyzer platforms in the clinical laboratory. Paper inserts and cardboard packaging, however, presented opportunities for recycling.