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Introduction: Xylazine is a veterinary anesthetic increasingly present alongside illicit fentanyl in the US and Canada, presenting novel health risks. Although xylazine remains less common in the Western US, Mexican border cities serve as key trafficking hubs and may have higher prevalence of novel substances, but surveillance has been limited. Methods: We examined deidentified records from the Prevencasa harm reduction clinic in Tijuana, describing urine and paraphernalia testing from patients reporting using illicit opioids within 24 hr. Xylazine (two types), fentanyl, opiate, methamphetamine, amphetamine, benzodiazepine, and nitazene test strips were used to test urine and paraphernalia samples. Paraphernalia samples were also analyzed with mass spectrometry. Results: The study consisted of 23 participants that provided both urine and paraphernalia samples. Of the participants studied, 100 %, 91.3 %, and 69.6 % reported using China White/fentanyl, methamphetamine, and tar heroin, respectively. The mean age was 41.7 years, 95.7 % were male, 65.2 % were unhoused, and 30.4 % had skin wounds at the time of sample collection.Xylazine positivity in urine, for the two types used, was 82.6 % and 65.2 %. For paraphernalia testing, the xylazine positivity was 65.2 % and 47.8 %. Confirmatory testing of paraphernalia samples by mass spectrometry indicated a 52.2 % xylazine positivity. This testing also revealed positivity rates for fentanyl (73.9 %), fluorofentanyl (30.4 %), tramadol (30.4 %), and lidocaine (30.4 %).The mass spectrometry results suggest lidocaine triggered n = 3 and n = 0 false positives among the xylazine test strip types. A total of n = 0 and n = 1 false negatives were also observed. Discussion: Xylazine is present on the U.S.-Mexico border, requiring public health intervention. High lidocaine positivity complicates the clinical detection of xylazine via testing strips. Xylazine was found to be more prevalent in urine than in paraphernalia samples. Confirmatory urine studies are needed to better understand possible complications of using test strips for toxicological testing.

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INTRODUCTION: Although effective antiretroviral and pre-exposure prophylaxis/PrEP regimens are available globally, adherence challenges persist. Objective measures of adherence can both measure adherence accurately and can be used to drive interventions. The first point-of-care pharmacologic adherence measure, urine tenofovir testing using a lateral flow assay, is now available. AREAS COVERED: This review examines the ability of pharmacologic metrics of adherence to predict HIV and PrEP clinical outcomes and the past use of pharmacologic metrics of adherence as tools to drive adherence interventions. The success of preliminary studies using point-of-care adherence metrics to guide interventions is then discussed. EXPERT OPINION: Large randomized clinical trials are now needed to test the impact of point-of-care adherence interventions on HIV and PrEP clinical outcomes, given promising results of the pilot studies summarized here. Hybrid implementation-effectiveness studies will be needed to examine optimal approaches to incorporating point-of-care testing into routine clinical care delivery, including in guiding resistance testing, adherence counseling, and delivery of other evidence-based adherence interventions. Given the ability of point-of-care tenofovir testing to be implemented in settings where viral load testing is not available, and at more frequent intervals due to its low cost, urine-based tenofovir assays have the potential to be highly scalable in diverse clinical settings.

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The standard protocol in addiction treatment/pain management is to conduct immunoassay screens for major drugs subject to misuse, followed by confirmatory testing of positive results. However, this may miss unscreened or rarely screened drugs that could pose risks, especially to polydrug users. We sought to determine the prevalences of unscreened/rarely screened drugs in a sample of individuals misusing drugs in 7 U.S. states, and to compare the results of urine vs. oral testing for these drugs by direct-to-definitive liquid chromatography/tandem mass spectrometry (LC-MS-MS). The five drugs with the highest prevalences were: gabapentin (16.8%), quetiapine (6.2%), chlorpheniramine (5.3%), hydroxyzine (4.9%), and ephedrine (3.5%). All have clinical significance as indicated by severity of possible side effects, interactions with other drugs, and/or misuse potential. Drugs were generally detected more frequently in oral fluid than urine, but gabapentin was more frequently detected in urine. The prevalences of the included drugs seem high enough, and their clinical significance important enough, to warrant consideration of expanding clinical drug test panels, either by direct-to-definitive testing or the addition of selected immunoassay screens when available. Oral fluid was usually more suitable than urine as the test matrix, given the higher rates of detection in oral fluid for most substances included in this study.

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Hepatocellular carcinoma (HCC) is the most predominant primary liver cancer, causing many illnesses and deaths worldwide. The insidious clinical presentation, difficulty in early diagnosis, and the highly malignant nature make the prognosis of HCC extremely poor. The complex and heterogeneous pathogenesis of HCC poses significant challenges to developing therapies. Urine-based biomarkers for HCC, including diagnostic, prognostic, and monitoring markers, may be valuable supplements to current tools such as serum α-fetoprotein (AFP) and seem promising for progress in precision medicine. Herein, we reviewed the major urinary biomarkers for HCC and assessed their potential for clinical application. Molecular types, testing platforms, and methods for building multimolecule models in the included studies have shown great diversity, thus providing abundant novel tools for future clinical transformation and applications.

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BACKGROUND: The aims are to compare the results of presumptive drug testing with confirmation of positives vs. direct-to-definitive drug testing, combined with investigation of urine vs. oral fluid as test matrices. METHODS: Paired oral fluid and urine specimens were collected voluntarily and anonymously from 1098 individuals applying for methadone treatment in 11 clinics across 7 U.S. states. All specimens were analyzed by immunoassay (IA) and liquid chromatography-tandem mass spectrometry (LC-MS-MS). RESULTS: Confirmed IA prevalences for urine were significantly higher than for oral fluid for 7 out of 10 drug classes - benzodiazepines, cannabis, cocaine, methadone, opiates, oxycodone and tramadol. Drug prevalences by direct-to-definitive LC-MS-MS were either the same or higher than prevalences by confirmed IA. Drug prevalences by LC-MS-MS were higher in urine for two drug classes (cocaine, methadone) and higher in oral fluid for two drug classes (buprenorphine, tramadol), but were equivalent in urine and oral fluid when averaged over all 10 drug classes. Certain drugs of special concern such as heroin and buprenorphine were more frequently detected in oral fluid than urine. CONCLUSIONS: Urine analysis showed some technical advantage over oral fluid in sensitivity to several drug classes within a confirmed IA testing protocol, but this may be outweighed if there is reason to believe that tampering with urine specimens is a significant problem. Overall drug detection by direct-to-definitive testing was similar for oral fluid and urine, but one matrix may be preferable if there is a particular drug of clinical or epidemiological interest.

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Testing for high-risk human papillomavirus (HPV) as part of primary cervical cancer screening has become more common recently. The Cobas 6800, an FDA-approved cervical screening platform, detects 14 high-risk HPVs, including HPV16 and HPV18. However, this test is limited to only women, which leads to low screening rates in trans men and other non-binary people. The cervical screening of trans men and other genders, especially those lying on the female-to-male spectrum, is equally important. Furthermore, cisgender males, particularly homosexuals, are also prone to chronic HPV infections and serve as HPV carriers, transmitting it to women and other men through sexual contact. Another limitation of the test is its invasive specimen collection, which induces discomfort and genital dysphoria. Therefore, there is a need for an innovative, less invasive method that would allow the sampling process to be more comfortable. In this study, we assess the performance of the Cobas 6800 for high-risk HPV detection in urine samples spiked with HPV16, HPV18, and HPV68. The limit of detection (LOD) was calculated using a dilution series (1.25-10,000 copies/mL) over a course of three days. Furthermore, the clinical validation was performed by calculating sensitivity, specificity, and accuracy. The limit of detection ranged from 50-1000 copies/mL depending upon the genotype. Moreover, the urine test demonstrated a high clinical sensitivity of 93%, 94%, and 90% for HPV16, HPV18, and HPV68, with 100% specificity. The overall percent agreement was calculated to be 95% for both HPV16 and HPV18, and 93% for HPV68. The high concordance, reproducibility, and clinical performance of the current assay suggest that the urine-based HPV test fulfills the requirements for its use in primary cervical screening. Moreover, it has the potential to be used for mass screening to not only identify high-risk individuals, but also to monitor vaccine effectiveness.

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Background: Congenital cytomegalovirus (CMV) infection is the leading cause of hearing loss and neurocognitive delay among children. Affected infants may be asymptomatic at birth and even pass their universal hearing screen. Early identification of CMV-infected infants will allow earlier detection, evaluation and management. The prevalence of congenital CMV infection in the developed world varies geographically from 0.6% to 0.7% of all deliveries and certain regions are at higher risk. The prevalence of congenital CMV is unknown for our region. Aim: The purpose of this study was to determine the prevalence of CMV infection among the neonatal population at an urban, tertiary hospital in northeast Florida which serves a large population of patients with low socioeconomic status to assess if universal screening program for congenital asymptomatic CMV infection can be determined. Methods: The study was submitted and approved by our Institutional Review Board. We tested the urine for CMV infection in 100 asymptomatic newborns (>32 weeks gestational age and >1,750 g weight at the time of delivery) delivered between June 2016 and July 2017. Results: Urine CMV was tested on 100 infants. One infant had a positive urine NAAT for CMV, making the prevalence of congenital CMV infection among asymptomatic newborns in our hospitals' population 1%. Conclusion: CMV prevalence in our setting of an urban, tertiary hospital is relatively consistent with the national average of all congenital CMV infections. A policy of universal screening for congenital CMV may be necessary.

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Mixed flora in urine cultures usually occur due to pre-analytic contamination. In our outpatient urology clinic, we found a high prevalence of mixed flora (46.2%), which was associated with female sex and older age. Patient education did not impact the rate of mixed flora. Future efforts should target high-risk patients.

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BACKGROUND: Treatment progress is routinely monitored by urine testing in patients with opioid use disorder (OUD) undergoing buprenorphine medication-assisted treatment (MAT). However, interpretation of urine test results could be challenging. This retrospective study aims to examine the results of quantitative buprenorphine, norbuprenorphine, and creatinine levels in urine testing in relation to sublingual buprenorphine dosage to facilitate an accurate interpretation of urine testing results. METHODS: We reviewed the medical charts of 41 consecutive patients, who were residing in halfway houses where their medication intake was closely monitored and who had enrolled in an office-based MAT program at an urban clinic between July 2018 and June 2019. The patients' urine testing results were reviewed, and demographic variables were recorded. We focused on the patients treated with 8-, 12-, or 16-mg/day of buprenorphine, examining their urine buprenorphine, norbuprenorphine, and creatinine levels. Analysis of variance tested the statistical association between the dosage and urine testing results on the norbuprenorphine-to-creatinine ratio. RESULTS: A total of 240 urine samples from 41 patients were included for this study. The 41 patients received a mean buprenorphine dose of 10.5 ± 3.7 mg/day (range, 4-20 mg/day). Then, this study examined the distribution of the 240 urine samples and then focused on 184 urine samples that came from the 33 patients who were treated with 8-, 12-, and 16-mg/day of buprenorphine, the 3 most common dosages. All of the 184 urine samples had a creatinine level of >20 mg/dL and buprenorphine-to-norbuprenorphine ratio <50:1. The average norbuprenorphine-to-creatinine ratio in the 8 mg/day dosage group was 3.85 ± 2.24 × 10-4 (n = 66; range, 0.44-11.12). The respective ratios in the 12- and 16-mg dosage groups were 5.64 ± 3.40 × 10-4 (n = 83; range, 1.55-22.72) and 6.23 ± 4.92 × 10-4 (n = 35; range, 1.37-27.12). The 3 dosage groups differed significantly in the mean ratios (P < .01), except when the 12- and 16-mg dosage groups were compared (P = .58). The results of this study thus suggest that prescribers should pay attention to the following features: (1) unexpected substance(s) in urine testing, (2) creatinine level under 20 mg/dL, (3) buprenorphine-to-creatinine ratio over 50:1, (4) buprenorphine dosage over 24 mg/day, and (5) norbuprenorphine-to-creatinine ratio consistently under 0.5 × 10-4 in patients treated with 8 mg/day or 1.5 × 10-4 in patients treated with 12 mg/day or more. CONCLUSION: This study suggested parameters for interpreting quantitative urine test results in relation to buprenorphine intake dose in office-based opioid treatment programs.

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BACKGROUND: Mass spectrometry allows for analysis of multiple hormone and organic acid metabolites from small urine volumes; however, to assess the full extent of daily hormone production, 24-h urine collections are usually required. The aims of this study were, first, to confirm that mass spectrometric analysis of an array of hormones and organic acids would yield similar results in both liquid and dried urine, and, second, to determine if collection of four dried spot urine samples could be substituted for a 24-h collection when measuring reproductive hormones. METHODS: Two study populations were included in this prospective observational study. Twenty individuals collected both a spot liquid urine and dried urine on filter paper to analyze eight organic acids. A second group of 26 individuals collected both a 24-h urine and four dried spot urines during waking hours throughout the same day for evaluation of 17 reproductive hormones and metabolites; data from 18 of these individuals were available to compare liquid versus dried urine results. Dried urine was extracted, hydrolyzed, and derivatized before analysis by mass spectrometry; all analytes from dried urine were normalized to urine creatinine. RESULTS: Reproductive hormone results from dried and liquid urine were in excellent agreement with intraclass correlation coefficients (ICCs) greater than 0.90; comparison of dried to liquid urine for organic acids showed good to excellent agreement (ICC range: 0.75 to 0.99). Comparison between the 4-spot urine collection and 24-h urine collection methods showed excellent agreement (ICC > 0.9) for 14 of the 17 urine metabolites and good agreement for the others (ICC 0.78 to 0.85) with no systematic differences between the two methods of collection. CONCLUSIONS: The burden of urine collection can be reduced using collection of four spot dried urines on filter paper without compromising comparability with hormone results from a 24-h urine collection. A large number of urine analytes can be assessed from the dried urine with similar results to those from liquid urine. Given the ease of sample handling, this 4-spot dried urine assay would be useful for both clinical assessment of patients and for large epidemiologic studies.

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BACKGROUND: The role of urine studies in the detection of urinary tract infection (UTI) in febrile neutropenic patients with urinary symptoms (having a urinary catheter or having a positive urine analysis) is inarguable. However, the evidence is scarce regarding the indication for urine studies in asymptomatic (i.e., without urinary symptoms) patients with febrile neutropenia (FN) presenting to the emergency department (ED). The aim of this study is to evaluate the need for obtaining urine studies in asymptomatic febrile neutropenic patients. METHODS: This was a retrospective cohort study conducted on adult cancer patients who presented to the ED with FN and had no urinary symptoms. We included all ED presentations of eligible patients between January 2013 and September 2018. Student's t-test and Wilcoxon rank-sum test were used for continuous data, while Chi-square and Fisher's exact tests were used for categorical data. Participants were divided into two groups based on their urine culture (UC) results: negative and positive UCs. Two cut-offs were used for positive UC results: ≥105 cfu/mL and ≥104 cfu/mL. RESULTS: We included 284 patients in our study. The age of our patient population was 48.5±18.5 years. More than two-thirds (68.7%) of patients had severe neutropenia, while only 3.9% and 9.9% of the patients had positive UCs at ≥105 cfu/mL and ≥104 cfu/mL, respectively. UCs were expectedly positive in most patients with urinalysis (UA) abnormalities. However, 27.3% and 32.1% of patients with positive UCs at ≥105 cfu/mL and ≥104 cfu/mL respectively had a normal UA. CONCLUSIONS: In our study, the incidence of UTI in adult febrile neutropenic cancer patients who present to the ED without urinary symptoms is low. Consequently, routine urine testing may not be warranted in this population, as it adds unnecessary financial burdens on the patients and delays timely management.

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BACKGROUND: To reduce the risk of renal toxicity, urine specific gravity (SG) and pH (potential of hydrogen) parameters should be met before nephrotoxic chemotherapeutic agents are administered. The purpose of this study was to compare laboratory urine SG and pH values with those obtained with urine point-of-care (POC) testing methods commonly used when caring for children receiving nephrotoxic chemotherapeutic agents. METHOD: A method-comparison design was used to compare the values of three POC methods for SG (dipstick, automated dipstick reader, refractometer) and three pH (dipstick, automated dipstick reader, litmus paper) methods with laboratory analysis of 86 urine samples from 43 children hospitalized on a pediatric hematology oncology unit in a large academic medical center. The Bland-Altman method was used to calculate bias and precision between POC and laboratory values. RESULTS: Except for the SG refractometer, bias values from Bland-Altman graphs demonstrated poor agreement between POC and laboratory urine SG and pH results. The precision values between these methods indicated overestimation or underestimation of hydration or urine pH status. Compared with laboratory methods, 31% of POC visual reading of dipstick SG values were falsely low-putting the patient at risk of not receiving necessary hydration and subsequent nephrotoxicity. DISCUSSION: In conclusion, most POC urine testing methods for SG and pH are not accurate compared with laboratory analysis. Because laboratory analyses can take longer than POC methods to obtain results, clinicians need to collaborate with laboratory medicine to ensure that an expedited process is in place in order to prevent chemotherapy administration delays.

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@#BACKGROUND: The role of urine studies in the detection of urinary tract infection (UTI) in febrile neutropenic patients with urinary symptoms (having a urinary catheter or having a positive urine analysis) is inarguable. However, the evidence is scarce regarding the indication for urine studies in asymptomatic (i.e., without urinary symptoms) patients with febrile neutropenia (FN) presenting to the emergency department (ED). The aim of this study is to evaluate the need for obtaining urine studies in asymptomatic febrile neutropenic patients. METHODS: This was a retrospective cohort study conducted on adult cancer patients who presented to the ED with FN and had no urinary symptoms. We included all ED presentations of eligible patients between January 2013 and September 2018. Student’s t-test and Wilcoxon rank-sum test were used for continuous data, while Chi-square and Fisher’s exact tests were used for categorical data. Participants were divided into two groups based on their urine culture (UC) results: negative and positive UCs. Two cut-offs were used for positive UC results: ≥10 5 cfu/mL and ≥10 4 cfu/mL. RESULTS: We included 284 patients in our study. The age of our patient population was 48.5±18.5 years. More than two-thirds (68.7%) of patients had severe neutropenia, while only 3.9% and 9.9% of the patients had positive UCs at ≥10 5 cfu/mL and ≥10 4 cfu/mL, respectively. UCs were expectedly positive in most patients with urinalysis (UA) abnormalities. However, 27.3% and 32.1% of patients with positive UCs at ≥10 5 cfu/mL and ≥10 4 cfu/mL respectively had a normal UA. CONCLUSIONS: In our study, the incidence of UTI in adult febrile neutropenic cancer patients who present to the ED without urinary symptoms is low. Consequently, routine urine testing may not be warranted in this population, as it adds unnecessary financial burdens on the patients and delays timely management.

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BACKGROUND: Methadone maintenance is currently the predominant form of opioid substitution treatment available in the Republic of Ireland. Prescribing decisions currently involve urine testing for drug use. Urine testing may involve provision of a supervised sample in some circumstances, despite recommendations made in 2010 to abandon this practice. AIMS: This project aims to evaluate the accuracy and acceptability of oral fluid testing for patients on methadone maintenance and also gather patient views on their treatment. METHODS: Patients attending for methadone maintenance at 4 general practices were invited to take part in this study, which involved taking an additional oral fluid test and a questionnaire. RESULTS: Fifty-five patients agreed to participate. Fifty-two (95%) found the oral fluid test acceptable, and almost two-thirds would prefer to see it used instead of urine testing. Oral fluid provided similar results to urine testing for all drugs except benzodiazepines. Self-report identified cocaine and opiate use not detected by oral fluid or urine testing. CONCLUSION: This study presents evidence that oral fluid testing is acceptable to most patients. While oral fluid testing was inferior to urine testing for benzodiazepines, it may have an adjunctive role to play in methadone maintenance provision. Patients reported more negative than positive aspects of methadone maintenance.

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The optimal level of sodium intake remains controversial, and the effects on a broad range of cardiovascular (CV) conditions remain unknown. The Evaluation of sodium intake for the prediction of cardiovascular events in Japanese high-risk patients (ESPRIT) is a prospective observational study designed to investigate whether sodium intake assessed by spot urine testing is associated with adverse CV events. A total of 520 patients who visited our cardiology clinic with various cardiovascular risk profiles were included. Sodium intake was estimated by spot urine testing at the time of entry, and the measurement was repeated at least every 6 months during follow-up. The primary endpoint was composed of (1) hospitalization due to heart failure, (2) acute coronary syndrome, (3) cerebrovascular events, and (4) documented CV deaths. The secondary endpoint was all-cause mortality. During the median follow-up period of 5.2 years, there were 105 composite CV events (3.9%/year), including 60 hospitalizations due to heart failure, 9 acute coronary syndromes, 21 cerebrovascular events, 15 CV deaths, and 26 cases of all-cause mortality. The average sodium excretion (from a median of 14 measurements) during the follow-up period was 3.52 ± 0.67 g/day. After adjustment for age, sex, and body weight, higher sodium excretion ( ≥ 4.0 g/day) was associated with composite CV events (hazard ratio 1.79, confidence interval 1.01-3.15 compared with the reference value of 3.0-3.49 g/day) but not all-cause mortality. The ESPRIT study showed that high sodium excretion (≥ 4.0 g/day) was associated with the predefined composite CV events (UMIN ID: UMIN000005419).

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BACKGROUND: Patients may spike urine samples with buprenorphine during office-based opioid treatment to simulate adherence to prescribed buprenorphine, potentially to conceal diversion of medications. However, routine immunoassay screens do not detect instances of spiking, as these would simply result in a positive result. The aim of this study was to report on the experience of using quantitative urine testing for buprenorphine and norbuprenorphine to facilitate the identification of urine spiking. METHODS: This is a retrospective chart review of 168 consecutive patients enrolled in outpatient buprenorphine treatment at an urban academic medical setting between May 2013 and August 2014. All urine samples submitted were subjected to quantitative urine toxicology testing for buprenorphine and norbuprenorphine. Norbuprenorphine-to-buprenorphine ratio of less than 0.02 were further examined for possible spiking. Demographic and clinical variables were also extracted from medical records. Clinical and demographic variables of those who did and did not spike their urines were compared. Statistically significant variables from the univariate testing were entered as predictors of spiking in a regression analysis. RESULTS: A total of 168 patients were included, submitting a total of 2275 urine samples. Patients provided on average 13.6 (SD = 9.9) samples, and were in treatment for an average 153.1 days (SD = 142.2). In total, 8 samples (0.35%) from 8 patients (4.8%) were deemed to be spiked. All of the samples suspected of spiking contained buprenorphine levels greater than 2000 ng/mL, with a mean norbuprenorphine level of 11.9 ng/mL. Spiked samples were submitted by 6 patients (75.0%) during the intensive outpatient (IOP) phase of treatment, 2 patients (25.0%) during the weekly phase, and none from the monthly phase. Regression analysis indicated that history of intravenous drug use and submission of cocaine-positive urine samples at baseline were significant predictors of urine spiking. CONCLUSIONS: Even though only a small number of patients were identified to have spiked their urine samples, quantitative testing may help identify urine spiking during office-based opioid treatment with buprenorphine.

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BACKGROUND: The ketogenic diet (KD) is a very low-carbohydrate, high-fat and adequate-protein diet with no calorie limit that induces a metabolic condition called "physiological ketosis". It was first introduced to treat epilepsy in the 1920s and has become quite popular recently as weight-loss and performance-enhancing diet. Its therapeutic use in a range of diseases is under investigation. During KD interventions people are supposed to monitor compliance with the dietary regimen by daily urine testing for ketosis. However, there are no studies investigating the best time for testing. FINDINGS: Twelve healthy subjects (37 ± 11 years; BMI = 23.0 ± 2.5 kg/m2) were instructed to, during the sixth week of a KD and with stable ketosis, measure their urine (8×) and blood (18×) ketone concentration at regular intervals during a 24-h period. According to their 1-day food record, the subjects consumed on average a diet with 74.3 ± 4.0 %, 19.5 ± 3.5 %, and 6.2 ± 2.0 % of total energy intake from fat, protein and carbohydrate, respectively. The lowest blood ß-hydroxybutyrate (BHB) (0.33 ± 0.17 mmol/l) and urine acetoacetate (AA) (0.46 ± 0.54 mmol/l) concentrations were measured at 10:00, respectively. The highest BHB (0.70 ± 0.62 mmol/l) and AA concentrations were noted at 03:00, respectively. Via urine testing the highest levels of ketosis were found at 22:00 and 03:00 and the highest detection rates (>90 %) for ketosis were at 07:00, 22:00 and 03:00, respectively. CONCLUSIONS: These results indicate that ketonuria in subjects with stable ketosis is highest and can be most reliably detected in the early morning and post-dinner urine. Recommendations can be given regarding precise time of the day for measuring ketone bodies in urine in future studies with KDs.

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Attention must be focused on needed changes to the current United States law that restricts physicians who prescribe buprenorphine for the detoxification or treatment of Opioid Use Disorder, to accepting no more than 100 patients. The current system does not provide comprehensive treatment as defined by the American Society of Addiction Medicine (ASAM) criteria. In addition, it suffers from both fragmentation and stigma and will require a significant change to comply with ASAM's call for integrated delivery of comprehensive addiction treatment. This commentary calls for the development and implementation of "best practice," by recommending caution in lifting the 100 patient limit until substantial achievement of this goal occurs. The authors call for an increase to 200 in the patient limit to be restricted to those physicians who are Board Certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM) or in Addiction Psychiatry by the American Board of Psychiatry and Neurology (ABPN), or other responsible medical organizations. Any additional restriction lifting should follow a systemic evolution that rewards and documents competency. Such a system would involve the integration of treatment, treatment systems, and recovery with prescription medication. In addition, it should monitor emotional blunting, treatment progress and initiation of genetic addiction risk testing.

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Studies of substance abuse treatment outcomes that give priority to cessation of all drug use may obscure other tangible benefits of treatment that are important to patients. The aim of this study was to examine the association between changes in quality of life (QoL) and: (1) retention in treatment; and (2) opioid use as measured by self-report and urine testing. Participants were 300 African American men and women starting outpatient buprenorphine treatment. Participants completed assessments at baseline, three and six months consisting of the World Health Organization's Quality of Life brief scale, Addiction Severity Index, and urine testing for opioids. There were statistically significant increases over time across all four QoL domains: physical, psychological, environmental, and social. Self-reported frequency of opioid use was negatively associated with psychological QoL, but opioid urine test results were not significantly associated with any QoL domains. Continued treatment enrollment was significantly associated with higher psychological QoL and environmental QoL. Patients entering buprenorphine treatment experience improvements in QoL, which are amplified for patients who remain in treatment. Point-prevalence opiate urine test results obtained at each assessment were not associated with any of the QoL domains and may not accurately reflect improvements perceived by patients receiving buprenorphine treatment.

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BACKGROUND: Ethyl glucuronide (EtG) is an alcohol biomarker with potential utility as a clinical research and alcohol treatment outcome. Debate exists regarding the appropriate cutoff level for determining alcohol use, particularly with the EtG immunoassay. This study determined the EtG immunoassay cutoff levels that most closely correspond to self-reported drinking in alcohol-dependent outpatients. METHODS: Eighty adults with alcohol dependence and mental illness, taking part in an alcohol treatment study, provided urine samples 3 times per week for up to 16 weeks (1,589 samples). Self-reported drinking during 120 hours prior to each sample collection was assessed. Receiver operating characteristic analyses were conducted to assess the ability of the EtG immunoassay to detect self-reported alcohol use across 24- to 120-hour time periods. Sensitivity and specificity of EtG immunoassay cutoff levels was compared in 100 ng/ml increments (100 to 500 ng/ml) across 24 to 120 hours. RESULTS: Over half (57%) of the 1,589 samples indicated recent alcohol consumption. The EtG immunoassay closely corresponded to self-reported drinking from 24 (area under the curve [AUC] = 0.90, 95% confidence interval [CI]: 0.88, 0.92) to 120 hours (AUC = 0.88, 95% CI: 0.87, 0.90). When cutoff levels were compared across 24 to 120 hours, 100 ng/ml had the highest sensitivity (0.93 to 0.78) and lowest specificity (0.67 to 0.85). Relative to 100 ng/ml, the 200 ng/ml cutoff demonstrated a reduction in sensitivity (0.89 to 0.67), but improved specificity (0.78 to 0.94). The 300, 400, and 500 ng/ml cutoffs demonstrated the lowest sensitivity (0.86 to 0.33) and highest specificity (0.86 to 0.97) over 24 to 120 hours. CONCLUSIONS: For detecting alcohol use for >24 hours, the 200 ng/ml cutoff level is recommended for use as a research and clinical outcome.

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