Urine Sample For Testing Research Articles

Hope for Ostomates: A Carbon and Zeolite Impregnated Polyester Fabric Inhibits Urine Odor in Cancer Patients: A Randomized Experimental Study

Objective: Many individuals with bladder cancer have undergone a surgical urostomy and often complain of being self-conscious of the unpleasant smell of their own urine. The focus of this study was to test the efficacy of a pouch cover made of a carbon and zeolite containing polyester material to inhibit the smell of urine by comparing two trained dogs’ response time in detecting volatile organic compounds (VOCs) in urine, with and without the fabric covering the samples. Methods: This study used a randomized, blinded experimental design to evaluate the efficacy of a fabric to interfere with two highly trained dogs’ ability to detect specific VOCs present in the urine of prostate cancer patient. Ninety urine samples were analyzed in this study. Results: Prior to the experiment, both dogs accurately detected VOCs in the uncovered test urine samples of men with prostate cancer with a sensitivity and specificity of nearly 100%. Both dogs recognized the “uncovered” urine samples of men with prostate cancer within two seconds. When the test sample was covered with the study fabric, the test urine samples were detected within 30-40 seconds and in some instances the dogs were not able to identify the covered samples, whatsoever. Conclusion: The findings of this study demonstrate that the carbon and zeolite containing polyester fabric did significantly interfere with the ability of the dogs to detect VOCs in urine of men with prostate cancer. The fabric may show promise as a pouch cover in controlling offensive urine odor which many ostomates experience.

Depletion of clomiphene residues in eggs and muscle after oral administration to laying hens

ABSTRACT The selective oestrogen receptor modulator (SERM) clomiphene is therapeutically used to induce ovulation. While prohibited as a doping agent in sports, it is frequently detected in sports drug testing urine samples. Few reports exist on clomiphene’s (illicit) use in the farming industry to increase the egg production rate of laying hens, which creates a risk that eggs as well as edible tissue of these hens contain residues of clomiphene. To investigate the potential transfer of clomiphene into eggs and muscle tissue, laying hens were orally administered with clomiphene citrate at 10 mg/day for 28 days. To determine clomiphene residues in eggs, chicken breast and chicken thigh, the target analyte was extracted from homogenised material with acetonitrile and subjected to ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) analysis. The test method reached a limit of quantification (LOQ) of 1 µg/kg and was characterised concerning specificity, precision, trueness and linearity. Analyses were performed on whole egg, egg white and yolk separately, and chicken muscle from breast and thigh. Clomiphene was detectable in eggs two days after the beginning of the drug administration period. The drug concentrations increased to 10–20 µg per egg within one week, and after withdrawal of clomiphene, residues decreased after 4 days, but traces of clomiphene were still detectable until the end of the study (14 days after the last administration). In the chicken’s muscle tissue, clomiphene levels up to 150 µg/kg (thigh) and 36 µg/kg (breast) were found. Six days after the last dose, tissue clomiphene concentrations fell below the LOQ. Overall, these results underline the concerns that clomiphene may be transferred into animal-derived food and future research will therefore need to focus on assessing and minimising the risk of unintentional adverse analytical findings in doping controls.

Attitudes and Preferences Regarding Non-Clinic-Based Self-Collection for Sexually Transmitted Infection Testing Among Clinic Attendees in British Columbia, Canada.

Sexually transmitted infections (STIs) are a global epidemic; although screening programs reduce transmission, barriers, including access and stigma, hinder success. The World Health Organization highlights the ability to maintain health without the direct support of a health care provider as one form of self-care, which can be applied to STI testing. Self-care through non-clinic-based self-collection for STI testing can address barriers while providing comprehensive care. Before implementation of innovative changes to screening approaches, it is important to understand if communities who rely on in-person care will self-collect outside of the clinic setting. This study investigated willingness to use non-clinic-based self-collection for STI testing among STI clinic attendees in British Columbia, Canada. Participants (n = 446) were recruited from STI clinics offering clinic-based self-collection for STI testing and completed a survey assessing self-care attitudes, including willingness to self-collect urine samples, throat swabs, and anogenital swabs outside of the clinic setting. Descriptive statistics, bivariable analyses, and multivariable models were conducted to investigate willingness to use non-clinic-based STI self-collection methods and associated correlates. This population reported high willingness to use non-clinic-based self-collection methods for STI testing (urine samples, 73%; throat swabs, 67%; anogenital swabs, 65%). Those aged 35 to 54 years compared with 15 to 34 years were more likely to be willing (adjusted odds ratio, 1.87; 95% confidence interval, 1.03-3.50); those identifying as straight/mostly straight compared with gay/lesbian were less likely to be willing (adjusted odds ratio, 0.39; 95% confidence interval, 0.23-0.65). Non-clinic-based self-collection for STI testing can address barriers to testing while maintaining quality care. Those currently receiving in-person care find these methods highly acceptable. These findings reinforce that self-collection for STI testing used in British Columbia clinics is acceptable to clients and may be extended to collection performed outside of the clinical setting.

A Single Method for 127 Recommended and Additional DUID Drugs in Blood and Urine by LC-MS-MS.

Driving under the influence of drug (DUID) cases continue to challenge forensic toxicologists as both the volume and complexity of casework increases. Comprehensive DUID testing should also meet the drafted Academy Standards Board (ASB)/ American National Standard Institute (ANSI) standard and the National Safety Council's Alcohol, Drugs and Impairment Division (NSC-ADID) recommendations. A simple method using protein precipitation followed by filtration extraction with an 8 minute run time by liquid chromatography-tandem mass spectrometry (LC-MS-MS) was developed, and a comprehensive ASB/ANSI validation was performed. Target drugs and metabolites were quantitatively assessed in blood and qualitatively assessed in urine. Included were 127 target analytes including cannabinoids (12), amphetamines (11), cocaine and metabolites (6), benzodiazepines (36), Z-drugs (5), opioids (27), anticonvulsants (3), first-generation antihistamines (6), muscle relaxants (2), dissociatives and hallucinogens (6), barbiturates (10), and miscellaneous substances (3). Limits of detection are appropriate for DUID and other forensic casework such as drug-facilitated crime (DFC) and postmortem investigations. To demonstrate applicability, 78 proficiency test blood and urine samples and 1,645 blood and urine samples from authentic cases samples demonstrated effective detection of target analytes in forensic casework. By increasing the analytical scope of multiple drug classes via a single method, this technique detects drugs that may have previously gone undetected, such as flualprazolam, etizolam, mitragynine, gamma-hydroxybutyric acid and psilocin and improves laboratory efficiency by reducing the number of tests required. The described method is, to the authors' best knowledge, the only published single procedure to meetall drugs listed in the drafted ASB/ANSI standard and recommended Tier 1 and traditional drugs from Tier 2 for DUID screening, while also achieving many drug scope and sensitivity recommendations for DFC and postmortem testing.

Scaling Up CareKit: Lessons Learned from Expansion of a Centralized Home HIV and Sexually Transmitted Infection Testing Program.

Despite advances in implementing human immunodeficiency virus (HIV)/sexually transmitted infection (STI) services for men who have sex with men (MSM), many remain underserved because of barriers like stigma, low facility coverage, and provider competency. This article describes the implementation of centralized nationwide mailed HIV/STI home testing (CareKit). The Emory Center for AIDS Research developed CareKit for research study participants to request HIV self-test kits, STI specimen collection kits, and condom/lubricant packs to be shipped to any mailing address in the United States. Sexually transmitted infection kits were customized according to study needs and could include materials to collect whole blood, dried blood spots, urine sample, and rectal and pharyngeal swab samples for syphilis, gonorrhea, and chlamydia testing. Specimens were mailed back to a central Clinical Laboratory Improvement Amendments-approved laboratory for testing, and results were returned to participants. CareKit was used by 12 MSM studies and mailed 1132 STI kits to 775 participants between January 2018 and March 2020. Participants returned 507 (45%) STI kits, which included 1594 individual specimens. Eighty-one kits (16%) had at least one positive STI test result: pharyngeal chlamydia (n = 7), pharyngeal gonorrhea (n = 11), rectal chlamydia (n = 15), rectal gonorrhea (n = 12), genital chlamydia (n = 6), genital gonorrhea (n = 1), and syphilis (n = 54). In this same 2-year period, 741 HIV self-test kits were mailed to 643 MSM. CareKit successfully met studies' needs for home HIV/STI testing and diagnosed many STIs. These processes continue to be adapted for research and programs. The ability to mail home test kits has become increasingly important to reach those who may have limited access to health care services, particularly during the COVID-19 pandemic.

A method for the analysis of 121 multi-class environmental chemicals in urine by high-performance liquid chromatography-tandem mass spectrometry

Biomonitoring of human exposure to environmental chemicals has gained momentum in recent years. Biomonitoring methods often include analysis of a single class of chemicals with similar chemical properties. In this study, we describe a method that involves solid-phase extraction (SPE) coupled with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and capable of measuring 121 environmental chemicals comprising plasticizers (PMs; n = 45), environmental phenols (EPs; n = 45), and pesticides (n = 31) through a single extraction of urine. Urine samples were incubated with 20 µL of β-glucuronidase/arylsulfatase (4000 units/mL urine) (from Helix pomatia) buffered at pH 5.5 for 2 h at 37 °C for optimal deconjugation conditions. We compared two extraction methods, namely liquid-liquid extraction and SPE, and the latter with ABS Elut NEXUS® cartridges was optimized to yield best extraction efficiencies. For increased resolution and chromatographic separation, two methods involving Ultra AQ C18® and Betasil™ C18® columns were used. The MS/MS analyses were performed under both negative and positive ionization modes. The optimized method yielded excellent intra- and inter-day variabilities (relative standard deviation: 0.40–11%) and satisfactory recoveries (80–120%) for >95% of the analytes. The limits of detection were ≤ 0.1 ng/mL for 101 analytes and between 0.1 and 1.0 ng/mL for 18 analytes. The optimized SPE LC-MS/MS method was validated through the analysis of standard reference materials and proficiency test urine samples and further applied in the analysis of 21 real urine samples to demonstrate simultaneous determination of 121 environmental chemicals in urine samples.

Global sensitivity analysis of randomized trials with nonmonotone missing binary outcomes: Application to studies of substance use disorders.

In this paper, we present a method for conducting global sensitivity analysis of randomized trials in which binary outcomes are scheduled to be collected on participants at prespecified points in time after randomization and these outcomes may be missing in a nonmonotone fashion. We introduce a class of missing data assumptions, indexed by sensitivity parameters, which are anchored around the missing not at random assumption introduced by Robins (Statistics in Medicine, 1997). For each assumption in the class, we establish that the joint distribution of the outcomes is identifiable from the distribution of the observed data. Our estimation procedure uses the plug-in principle, where the distribution of the observed data is estimated using random forests. We establish asymptotic properties for our estimation procedure. We illustrate our methodology in the context of a randomized trial designed to evaluate a new approach to reducing substance use, assessed by testing urine samples twice weekly, among patients entering outpatient addiction treatment. We evaluate the finite sample properties of our method in a realistic simulation study. Our methods have been implemented in an R package entitled slabm.

Point-of-Care Ultrasound for the Evaluation and Management of Febrile Infants.

Febrile infants frequently present to the emergency department (ED) and account for a vulnerable population at significant risk for serious bacterial infection. Appropriate evaluation and management are key to favorable outcomes but can present challenges for providers, especially in EDs where ill children are infrequently seen and pediatric-trained staff may not be available. Point-of-care ultrasound (POCUS) is integrated into the care of adults in the ED but is less commonly used for infants. We present a review of the current literature and proposed approach to using POCUS for bladder catheterization, lumbar puncture (LP), and vascular access in the resuscitation and evaluation of febrile infants. Point-of-care ultrasound can be a useful adjunct in the evaluation of febrile infants by facilitating higher success rates of infant bladder catheterization, LP, and intraosseous and intravenous (IV) line placement. Ultrasound has been shown to be a reliable method of evaluating bladder volumes before the catheterization of infants, reducing the number of attempts needed to obtain an adequate urine sample for testing and culture. Point-of-care ultrasound has also been shown to improve the yield of LPs in infants. Ultrasound is a rapid and accurate way of identifying the appropriate location and depth of needle insertion. Point-of-care ultrasound has also been shown to facilitate obtaining IV access in infants as well as confirming the proper placement of intraosseous lines. A growing body of evidence suggests that POCUS is a useful adjunct in the initial evaluation and resuscitation of febrile infants. It is the position of both the American Academy or Pediatrics, American College of Emergency Physicians, and the authors of this article that emergency physicians should be familiar with the indications and applications of POCUS in children. This technology should be used as an adjunct to improve success rates when performing bladder catheterization, LP, and obtaining intravenous/intraosseous access for infants.

Comparison of Machine Learning Algorithm For Urine Glucose Level Classification Using Side-Polished Fiber Sensor

Urine glucose levels can be used to determine if glucose levels in the human body are too high, which may be a sign of diabetes. A non-invasive urine glucose classification model was conducted by using of the color of urine after benedict reaction to measure the level of glucose. The aim of this study is to classification urine glucose levels from a side-polished fiber sensor performed by using machine learning algorithms to get the best algorithm performance. By removing the coating and cladding this sensor is made of a polymer optical fiber. The measurement is focused on changes in the cladding refractive index which affects the amount of light transmitted. The machine learning system has been implemented using the Naïve Bayes Classifier, k-Nearest Neighbor Classifier, Logistic Regression, Random Forest, Artificial Neural Networks and Support Vector Machine. The measurement data on samples were collected from previous studies of a total of 120 urine samples for testing in this study. The results of the experiments performed with k-fold cross validation show that the neural network gets the accuracy results of 96.7%, the value of precision 0.967, recall 0.967, and F1-Measure 0.967. With cross validation leave-one-out, the experimental results show the classification algorithm with the best accuracy value that is at the random forest and artificial neural networks 0.975, precision 0.975, recall 0975, and F1-Measure 0.975. While the ANN algorithm is superior in achieving an accuracy value of 98.6%. Therefore, artificial neural networks are the best method for classifying glucose levels in the human body for fasting and postprandial urine tests.

Assessing the need for routine safety testing for patients being treated with dupilumab for moderate-to-severe atopic dermatitis.

Atopic dermatitis (also known as AD or eczema) is a common skin disease that can cause intense and persistent itching and rashes. Skin creams or ointments are not suitable or effective for some patients with moderate-to-severe AD. In these patients, oral (taken by mouth) or injected medications may be required. Some of those oral or injected treatments could be toxic and often have unwanted side effects, especially when used for a longer period of time, so patients must be regularly tested to see whether those treatments are harming their blood or organs. Dupilumab is a newer injectable drug for treating moderate-to-severe AD. Dupilumab specifically targets key molecules in the body that cause AD. Dupilumab has been tested for up to one year in more than 2000 patients enroled in placebo-controlled clinical trials. During those trials, patients provided blood and urine samples for laboratory testing while they were being treated with dupilumab or placebo (dummy drug). In this paper, the authors from Germany and the U.S.A, analysed how blood cells, blood chemistry, and urine chemistry changed during treatment, to check whether dupilumab is safe to use without the need for regular laboratory tests. After performing many routine laboratory tests on patients' blood and urine, they found that there were no clinically important changes in test results that could be linked to dupilumab. They concluded that patients using dupilumab for moderate-to-severe AD do not need routine laboratory testing. This is a summary of the study: Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS).

The hand osteoarthritis of New York university (honey) registry: the impact of obesity and menopausal status

Purpose: Hand osteoarthritis (OA) data in the literature emanates mainly from cohorts of knee or hip OA. Targeted populations of hand OA could better define the clinical spectrum, address etiologies, and discern pathophysiology. While prevalence increases with age, other factors impacting onset and severity are unclear. Many studies suggest adiposity plays a metabolic role in OA beyond the increased mechanical load - as evidenced by a greater prevalence of hand OA in obese patients. Other reports link hormonal status to OA pain. We aimed to study factors contributing to hand OA in a dedicated cohort. Methods: We enrolled patients with interphalangeal (IP) and/or 1st carpometacarpal (CMC) OA by physical exam, excluding those with rheumatoid arthritis, psoriatic arthritis, and lupus. During a one-time visit, participants completed adapted versions of the Michigan Hand Outcomes and QuickDash questionnaires, provided blood and urine samples for future biomarker testing, and were asked about comorbidities, other sites of musculoskeletal disease, prior hand trauma, and current or prior treatments for hand pain. Hand radiographs were scored for involvement of 20 joints (18 IPs, 2 first CMCs), and specifically for presence of erosions. Results: Of 337 patients screened, 171 were eligible and willing to participate. The average age was 66.3±9.5 years (42 to 90) and BMI was 26.2±5.0 kg/m2 (16.4 to 42.1) with 88.5% Caucasian and 78.8% female. Plain radiographs (available for 149 patients) revealed an average of 10.5±5.1 affected joints, with concurrent CMC and IP OA involvement in most patients (69.1%) The average length of time between onset of hand pain and enrollment was 11.7 years. Most patients were diagnosed with OA after their symptoms began (6.6 years after, n=79) though many were diagnosed concurrently with initial occurrence of symptoms (n=53). Radiographs showed erosive changes in at least one joint in 36.5% of the patients. This subset with central erosions had a significantly higher number of joints affected overall (12.5 vs. 9.1, p=<0.001). Patients with BMI > 30 kg/m2 had significantly more hand pain (p=0.022), stiffness (p=0.047), and disability (p=0.025) compared to those with normal weight BMI < 25, despite similarities in age and number of joints affected. Patients reporting OA in additional sites also reported more hand pain (p=0.018) and disability (p=0.003), though they were older (67.7 vs. 62.3 years, p=0.010). Women reported significantly more pain (p=0.035), disability (p=0.004), and a higher average number of joints affected (p=0.020) than males with similar mean ages and BMI (Table 1). Within the female subset, those aged 48 to 54 years (likely to be perimenopausal, +/- 3 years of age 51) reported more pain and disability than younger or older patients, even though females > 54 years of age had more affected joints (Figure 1). This finding raises the possibility that perimenopausal women with hand OA may experience increased hand pain at onset of menopause with improvement upon its conclusion. Conclusions: We have established the only prospective registry and biorepository in North America focused primarily on hand OA. Our findings support literature that hand OA pain and disability may be due in part to an inflammatory-driven process exacerbated by adiposity, and reflect a higher OA burden. Estrogen-mediated mechanisms altered during menopause may also have a role in OA symptoms. We expect the HONEY registry will be useful for elucidating etiologies and pathophysiology, and facilitating clinical trials for emerging therapeutic options.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

An evaluation of the real world use and clinical utility of the Cxbladder Monitor assay in the follow-up of patients previously treated for bladder cancer

BackgroundSurveilling recurrent urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance.ObjectiveTo audit the clinical utility of a new surveillance protocol incorporating the Cxbladder Monitor (CxbM) test in real-world practice.MethodsThree hospitals implemented a new surveillance protocol. Patients were risk stratified, and then provided urine samples for CxbM testing. Low-risk CxbM-positive patients and all high-risk patients had cystoscopy at 2–3 months. Low-risk CxbM-negative patients had cystoscopy at ~ 12 months.Results443 CxbM tests were conducted on samples from 309 patients: 257 (83.2%) low-risk and 52 (16.8%) high-risk. No pathology-confirmed recurrences were seen in low-risk CxbM-negative patients (n = 108) during the first post-CxbM cystoscopy undertaken a mean ± SD 10.3 ± 3.9 months after testing. Three recurrences were detected during cystoscopy at 2.7 ± 3.4 months in 53 low-risk CxbM-positive patients. In 49 high-risk patients, 39 (79.6%) were CxbM-negative with no pathology-confirmed recurrences. Ten high-risk patients (20.4%) were CxbM-positive with four confirmed recurrences; 2 high-grade and 2 low-grade. The median time to first cystoscopy was 12.13 (95% CI: 11.97–12.4) months in patients with a CxbM-negative result versus 1.63 (95% CI: 1.13–2.3) months in patients with a CxbM-positive result (p < 0.00001). No positive cases were missed, no patients progressed to invasive or metastatic disease, and no patient died of cancer over 35 months of follow-up.ConclusionsCxbM accurately identified a high proportion of patients (77.8%) who were safely managed with only one cystoscopy per year. Including CxbM in the protocol for patient surveillance provided clinical utility by reducing the average number of annual cystoscopies by approximately 39%, thereby sparing patients the potential discomfort and anxiety, without compromising detection rates. No advantage was observed for risk stratification prior to CxbM.

Validation of the NIDA-modified ASSIST as a Screening Tool for Prenatal Drug Use in an Urban Setting in the United States.

Screening for prenatal drug use is recommended. The NIDA-modified Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST) is a screener for drug use that has not yet been validated with pregnant women. This study aims to assess the substance-specific diagnostic validity of the NM-ASSIST (not including tobacco or alcohol) in pregnant women and determine optimal cut-points for substance-specific substance involvement (SI) scores. Five hundred (500) pregnant women were recruited from 2 obstetric practices as part of a larger study of substance use screeners. Participants completed the NM-ASSIST, and provided urine and hair samples for testing. Receiver-operating characteristic curves were derived to determine the optimal SI score cut-points for each drug. Prevalence estimates of prenatal drug use as determined by hair/urine drug testing were: cannabis (32.0%), cocaine (9.9%), benzodiazepines (1.0%), prescription opioids (4.3%), and street opioids (1.7%). The proportion of participants screening positive based on optimal SI score cut-points were as follows: cannabis (39.1%), cocaine (2.3%), benzodiazepines (0.8%), prescription opioids (2.7%), and street opioids (1.7%). There were no screen positives for amphetamines, but 6 (1.2%) women had a positive amphetamine hair or urine test. Optimal cut-points to identify prenatal drug use were: cannabis, 2 (area under the curve [AUC] 0.87; sensitivity 0.82; specificity 0.85; diagnostic odds ratio [DOR] 26.9); cocaine, 2 (AUC 0.58; sensitivity 0.17; specificity 0.99; DOR 29.0); benzodiazepines, 15 (AUC 0.59; sensitivity 0.20; specificity 0.99; DOR 38.8); prescription opioids, 3 (AUC 0.61; sensitivity 0.25; specificity 0.98; DOR 18.3); and street opioids, 4 (AUC 0.55; sensitivity 0.13; specificity 0.99; DOR 9.3). The NM-ASSIST reliably distinguished pregnant women who use cannabis from those who do not, but performed poorly for all other substances. More research is needed to identify screeners that reliably detect all prenatal drug use. Although more cost-prohibitive, a combination of self-report and toxicological screening may be preferable for detecting prenatal drug use.

Known fentanyl use among clients of harm reduction sites in British Columbia, Canada

BackgroundNorth America is in the midst of an opioid overdose epidemic and it is commonly suggested that exposure to fentanyl is unknown. Using a provincial survey of harm reduction site clients, we aimed to characterize known and unknown fentanyl use and their correlates among people who use drugs in British Columbia, Canada. MethodsWe recruited 486 clients who were >18 years old and 316 agreed to provide a urine sample for substance use testing. Reported known fentanyl use was defined as a three-level categorical variable assessing recent (i.e., in the previous three days) fentanyl exposure: (i) known exposure; (ii) unknown exposure; and (iii) no exposure. We also assessed any exposure to fentanyl (Yes vs. No) confirmed by urinalysis. Survey data were summarized using descriptive statistics. Multinomial logistic regression and modified Poisson regression models were built to examine different correlates of exposure to fentanyl. ResultsMedian age of the participants was 40 (IQR: 32–49). Out of the 303 eligible participants, 38.7% (117) reported known fentanyl use, 21.7% (66) had unknown fentanyl use, and 39.6% (120) had no recent fentanyl use. In the adjusted multinomial logistic regression model and in comparison with unknown fentanyl use, recent known fentanyl use was significantly associated with self-report of methadone use (aRRR = 3.18), heroin/morphine use (aRRR = 4.40), and crystal meth use (aRRR = 2.95). Moreover, any recent exposure to fentanyl (i.e., positive urine test for fentanyl) was significantly associated with living in urban settings (aPR = 1.49), and self-reporting recent cannabis use (aPR = 0.73), crystal meth (aPR = 1.45), and heroin/morphine use (aPR = 2.48). ConclusionThe landscape of illicit opioid use is changing in BC and more people are using fentanyl knowingly. The increasing prevalence of known fentanyl use is concerning and calls for further investments in public awareness and public policy efforts regarding fentanyl exposure and risks.

Acceptability and Feasibility of a Telehealth Intervention for Sexually Transmitted Infection Testing Among Male Couples: Protocol for a Pilot Study.

BackgroundGay, bisexual, and other men who have sex with men (MSM) are at elevated risk for acquiring sexually transmitted infections (STIs) in the United States, especially chlamydia and gonorrhea. While research has indicated main partners over casual partners may play a central role in STI risk, the frequency of STI screening among MSM couples is particularly low. Self-sample collection for chlamydia and gonorrhea screening has been shown to be highly accurate, and at-home STI testing has been shown to be highly acceptable among diverse populations. However, there is little research exploring the feasibility and acceptability of at-home chlamydia and gonorrhea screening among MSM couples. Our pilot study aims to help evaluate the viability of this screening modality as an intervention tool for MSM couplesObjectiveThe objective of this study was to assess the feasibility and acceptability of an at-home chlamydia and gonorrhea sample collection and remote lab testing program among a sample of 50 MSM couples living in the United States.MethodsThis pilot study enrolled 50 MSM couples, ranging from 18-40 years old and living in the United States, who participated in a larger at-home HIV testing randomized controlled trial. Participating couples completed a pretest instructional video call and then had the option of completing at-home sample collection across three bodily sites (rectal swab, pharyngeal swab, and urine sample) for remote chlamydia and gonorrhea lab testing. For participants who completed any sample collection, they received their results via a posttest video call. All participants completed an online survey examining satisfaction and acceptability of the home testing process, experience with logistics, willingness to test at home in the future, recent sexual risk behavior, STI testing history, and linkage to care. A subset of 10 couples completed an in-depth interview about their attitudes towards the sample collection process, different decisions they made while collecting their samples, and their experience accessing treatment (for those who received a positive result).ResultsRecruitment began in September 2017, and as of March 2019 a total of 50 couples have been enrolled. Overall, 49/50 couples have returned their samples and completed the posttest delivery call, and 10 in-depth interviews have been completed and transcribed.ConclusionsScreening MSM couples at home for chlamydia and gonorrhea and providing video-facilitated results delivery may offer a tailored approach to address the increasing prevalence of these STIs. By collecting data on how MSM couples experience at-home STI screening, this project will provide valuable insight into the utility of such a service delivery program to public health interventionists and researchers alike.International Registered Report Identifier (IRRID)DERR1-10.2196/14481

The urostomy: The poor relation?

Aims/ObjectiveTo discuss the findings of a small research project about knowledge of urostomies amongst health care professionals (HCPs).BackgroundThe lead author's urostomy was formed in 2015. From early dealings with HCPs, it was clear that knowledge about urostomies was lacking. In particular, many do not know how to take an uncontaminated urine sample for testing. This has led to treatment delays, anxiety and frustration and caused the author to question care she had received. Discussions with other patients suggested a commonality in experience.Method and findingsWorking with a researcher from a UK‐based stoma charity, we conducted a small qualitative survey of urostomates via a Facebook support group. This asked the question: “How knowledgeable have you found Healthcare Professionals about urostomies?” 52 patients responded. Of these, 50 indicated that lack of knowledge was normal in encounters with HCPs. While in some clinical settings this is understandable, it was notable that some respondents recorded instances where staff on urological wards seemed to confuse a nephrostomy with a urostomy.ConclusionUrostomies are rare. It is estimated that 10 000 people in the United Kingdom have a urostomy, compared with between 110 000 and 120 000 with colostomies/ileostomies. HCPs encounter few during their career. Finding a way to embed knowledge and keep it up‐to‐date is therefore central to the problem. Our project has provided the impetus for larger scale research, with the aim of addressing this issue and improving the treatment and care that patients with urostomies receive.

Confirmed marijuana use and lymphocyte count in black people living with HIV

BackgroundMarijuana is a commonly used recreational substance with purported analgesic and mood enhancing properties. Many people living with HIV identify marijuana as a palliative substance. However, through its main psychoactive component, tetrahydrocannabinol (THC), is known to influence the immune system. The effects of marijuana use in people with HIV are still controversial, with very scant literature in Black adults. MethodsThe current study determined the differences in the lymphocyte count, specifically the number cluster differentiation 4 and 8 (CD4+ and CD8+), among patients who urine drug tested negative for THC (n = 70) and those who tested positive for THC (n = 25). The sample included 95 Black people living with HIV, 51% female, with a mean age of 46 ± 11 years. Participants provided a urine sample for substance use testing and a trained researcher extracted clinical data from clinical charts on the day of appointment. ResultsAfter adjusting for demographic and HIV-related covariates, THC-positive patients had significantly higher CD4+ and CD8+ counts than their THC-negative counterparts. ConclusionThese results extend previous HIV-related immunity findings in an underrepresented group, and suggest that THC use does not reduce immune function as measured by CD count. Further research is warranted on the overall effects of THC on immune function in HIV positive patients.

Simultaneous Determination of Uranium and Depleted Uranium Isotopic Ratio Using Inductively Coupled Mass Spectrometry.

We have developed and validated a method for the simultaneous quantitative measurement of total uranium (TU) and uranium 235 U/238 U isotopic ratio (UIR) in urine by inductively coupled plasma mass spectrometry (ICP-MS) using a Thermo Scientific iCAP-Q instrument. The performance characteristics of the assay were determined to be in compliance with clinical laboratory standards. The assay was linear in the concentration range of 1.0 to 500.0 ng/liter TU. The method was precise and accurate with limits of detection of 2.5 ng/liter for TU and 9.8 ng/liter for UIR. The accuracy was >93% and the coefficient of variation (% CV) was <5.0% for both TU and UIR. All results were within established guidelines and agreed-upon criteria, and the results fell within the certified range for the reference controls. The method has thus been shown to be effective as a simple, precise, and sensitive analytical technique for testing urine samples. © 2018 by John Wiley & Sons, Inc.

Abstract B32: RADIANCE: An open-label, nonrandomized, prospective biomarker study to assess analytic concordance between noninvasive testing and tissue testing for EGFR T790M mutation detection in patients with non-small cell lung cancer

Abstract Background: EGFR-TKIs are the recommended first-line therapy of patients (pts) with advanced non-small cell lung cancer (NSCLC) who have an EGFR-sensitizing mutation (EGFRm). However, most pts develop resistance to EGFR-TKIs, with the EGFR T790M resistance mutation observed in &amp;gt;50% of pts on first- and second-generation EGFR-TKIs. Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both EGFRm and T790M resistance mutations, recommended for pts with T790M-positive advanced NSCLC who have progressed on first-line EGFR-TKI therapy. Tumor tissue is the preferred sample source for T790M testing; however, often tumor biopsy is not feasible following disease progression due to inaccessible sites and/or concerns about safety. Testing using plasma samples offers a less invasive, albeit less sensitive, alternative method for the detection of T790M-positive circulating tumor (ct) DNA. Additional noninvasive options, including urine ctDNA analyses, are also being investigated. The RADIANCE trial is designed to determine if urine and plasma tests can provide similar detection rates to tissue testing for T790M detection when combined. Pts identified as T790M-positive may be offered treatment with osimertinib. Trial Design: RADIANCE (NCT03137264) is an open-label, prospective biomarker study with a primary objective of assessing the analytic concordance between noninvasive testing (Guardant360 Plasma Assay and Trovera Liquid Biopsy Test using urine) and tissue testing (cobas® EGFR Mutation Test v2) for T790M in pts with NSCLC. Approximately 470 pts will be enrolled. The study consists of two parts, Diagnostic Analytic Validity (Part 1) and Clinical Outcomes (Part 2). In Part 1, eligible pts will provide a tumor biopsy (cobas tissue test), plasma (cobas plasma and Guardant360 tests) and urine sample (Trovera test) for T790M testing. Eligibility criteria include a primary diagnosis of EGFRm-positive NSCLC with evidence of disease progression during or following treatment with a first- or second-generation EGFR-TKI. Pts must not be enrolled on another clinical trial, or have previously received osimertinib or another T790M-directed therapy. In Part 2, pts with T790M-positive status by cobas tissue and/or cobas plasma test will be treated according to standard of care, and may receive osimertinib. Pts will be followed for clinical outcomes for up to 18 months, and evaluated for objective response, progression-free survival, and duration of response (investigator-assessed using RECIST v1.1) and safety. Pts who are T790M negative or do not receive osimertinib will have completed the study after Part 1. Citation Format: Hatim Husain, Martin Dietrich, Steven Dubinett, David E. Gerber, Jeffrey Gregg, Michelle Shiller, Howard West, Kim Thai, Alvin Milner, Nabil Chehab, Christina Baik. RADIANCE: An open-label, nonrandomized, prospective biomarker study to assess analytic concordance between noninvasive testing and tissue testing for EGFR T790M mutation detection in patients with non-small cell lung cancer [abstract]. In: Proceedings of the Fifth AACR-IASLC International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic; Jan 8-11, 2018; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2018;24(17_Suppl):Abstract nr B32.

Coherent fluctuation nephelometry as a promising method for diagnosis of bacteriuria

ObjectivesSpecialized analyzers are used to automate the diagnosis of bacteriuria in laboratory practice. They are based on analysis of microorganisms concentration in urine samples or recording the growth of urine microflora. Coherent fluctuation nephelometry (CFN) has high sensitivity and allows analyzing both parameters simultaneously. The aim of the study is to compare the effectiveness of CFN-based and flow cytometry based analyzers. Design and methodsTotal 117 urine samples from children were studied in parallel using the CFN-analyzer and UF-1000i (Sysmex), the results were confirmed by conventional microbiological methods. ResultsIn 21 urine samples (18%), significant bacteriuria was determined (≥104 CFU/ml). The best diagnostic indicators were obtained while testing urine samples using the CFN-analyzer. The most efficient bacteriuria diagnosis is achieved by simultaneous analyses of microorganisms concentration in urine and growth of urine microflora (sensitivity – 95.2%, specificity – 96.9%, positive predictive value – 87%, negative predictive value – 98.9%, diagnostic odds ratio – 81.7, positive likelihood ratio – 30.5, negative likelihood ratio– 0.049, area under curve in ROC-analysis – 0.987). The CFN-analyzer allows the preliminary selection of negative urine samples, which do not require further analysis by conventional microbiological methods, thereby decreasing the number of cultures by 80.3%. ConclusionsThis study suggests that the CFN-analyzer is the effective tool for bacteriuria screening in children.