scholarly journals Protocol for Accuracy of Point of Care (POC) or In-Office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. E1-E22
Author(s):  
Laxmaiah Manchikanti

Background: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. Study Design: A diagnostic accuracy study of urine drug testing. Study Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. Methods: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. Results: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. Limitations: The limitations include lack of availability of POC testing with lower cutoff levels. Conclusion: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. Clinical Trial Registration: NCT 01052155 Key words: Controlled substances, opioids, benzodiazepines, illicit drugs, abuse, diversion, adherence monitoring, prescription monitoring programs

2017 ◽  
Vol 11 ◽  
pp. 117822181772478 ◽  
Author(s):  
Hope M Smiley-McDonald ◽  
Katherine N Moore ◽  
David C Heller ◽  
Jeri D Ropero-Miller ◽  
Gregory L McIntire ◽  
...  

This study is a 6-month retrospective analysis of urine drug testing (UDT) data from a pain management population among specimens with clinician-ordered marijuana testing (N = 194 809). Descriptive statistics about the specimen positivity of clinician-ordered marijuana UDT are provided as well as other drug positivity. Specimens from men and adults aged 18 to 34 years had the highest prevalence rates of marijuana positivity. The prevalence of past-month marijuana use among a comparative national population was lower than the prevalence of positive marijuana tests in the UDT specimens by all characteristics. Among the specimens tested for illicit drugs and marijuana, 4.0% were positive for amphetamine, 2.8% were positive for cocaine, and 0.9% were positive for heroin. The most common prescription drugs listed were opioids (64.7%), benzodiazepines (20.5%), and antidepressants (19.9%). In sum, the findings reflect previous research showing high rates of marijuana use, illicit drug use, and prescription drug use in a pain management population.


2019 ◽  
Vol 10 ◽  
pp. 215013271988363
Author(s):  
Fatima Hosain ◽  
Josephine Lee ◽  
Ashar Ata ◽  
Ravneet K. Bhullar ◽  
Andrew K. Chang

Objective: The effect of specific urine drug testing (UDT) results on physician prescribing habits has not been well described. The primary objective was to report renewal rates of chronically prescribed controlled substances based on types of inconsistent UDT results. Methods: We conducted a retrospective chart review over a 5-month period comparing prescription renewals rates for patients with consistent versus inconsistent UDTs. Inconsistent UDTs were defined by prescribed drug not detected or the presence of heroin, cocaine, nonprescribed opioids, nonprescribed benzodiazepines, or marijuana. Results: Of the 474 UDTs reviewed, 214 (45.1%) were inconsistent. The most common findings among inconsistent UDTs, including overlapping results, were prescribed drug not detected (26.8%) and the presence of marijuana (20.7%), nonprescribed opioids (9.9%), and nonprescribed benzodiazepines (6.1%). In contrast, cocaine (5.5%) and heroin (0.4%) were less likely to be found on UDTs for this population. The relative risk (RR) of prescription renewal was 0.64 (95% CI 0.57-0.71) for inconsistent UDTs versus consistent UDTs. Within the inconsistent UDTs, the renewal rates when marijuana (79.6%) or nonprescribed opioids or benzodiazepines (63.6%) were present were much higher than when heroin or cocaine were present (0.0%; P < .001). Patients whose prescribed controlled substance was not detected had a 55.8% renewal rate. Conclusions: Prescription renewal rates were high when patient UDTs contained nonprescribed marijuana, opioids, and benzodiazepines, or when the prescribed drug was not detected. Prescription renewal rates were low when illicit drugs, such as heroin and cocaine, were detected.


2019 ◽  
Vol 499 ◽  
pp. 81-86 ◽  
Author(s):  
Mehran Haidari ◽  
Sravan Mansani ◽  
Dezaray Ponds ◽  
Lissett Romero ◽  
Christine Cobb ◽  
...  

2019 ◽  
Vol 19 (8) ◽  
pp. 852-861 ◽  
Author(s):  
Tobias Broger ◽  
Bianca Sossen ◽  
Elloise du Toit ◽  
Andrew D Kerkhoff ◽  
Charlotte Schutz ◽  
...  

2021 ◽  
Author(s):  
Flora Martinez Figueira Moreira ◽  
Renu Verma ◽  
Paulo Cesar Pereira dos Santos ◽  
Alessandra Leite ◽  
Andrea da Silva Santos ◽  
...  

SummaryBackgroundThere is a need to identify scalable tuberculosis screening strategies among high burden populations. The WHO has identified a non-sputum-based triage test as a development priority.MethodsWe performed a diagnostic accuracy study of point-of-care C-reactive protein (CRP) and Xpert-MTB-Host-Response (Xpert-MTB-HR) assays in the context of a mass screening program for tuberculosis in two prisons in Brazil. Incarcerated individuals irrespective of symptoms were screened by sputum Xpert-MTB/RIF and sputum culture. CRP was quantified in serum by a point-of-care assay (iChroma-II) and a 3-gene expression score was quantified from whole blood using the Xpert-MTB-HR cartridge. We evaluated receiver operating characteristic area under the curve (AUC) and assessed specificity at 90% sensitivity and sensitivity at 70% specificity, consistent with WHO target product profile (TPP) benchmarks.FindingsTwo hundred controls controls and 100 culture- or Xpert-positive tuberculosis cases were included. Half of tuberculosis cases and 11% of controls reported any tuberculosis symptoms. AUC for CRP was 0.79 (95% CI: 0.73-0.84) and for Xpert-MTB-HR was 0.84 (95% CI: 0.79-0.89). At 90% sensitivity, Xpert-MTB-HR had significantly higher specificity (53.0%, 95% CI: 45.0-69.0%) than CRP (28.1%, 95% CI: 20.2-41.8%) (p=0.003). Among individuals with medium or high sputum Xpert semi-quantitative load, sensitivity (at 70% specificity) of CRP (90.3%, 95% CI: 74.2-98.0) and Xpert-MTB-HR (96.8%, 95% CI: 83.3-99.9%) was higher.InterpretationFor active case finding in this high tuberculosis-burden setting, CRP and Xpert-MTB-HR did not meet TPP benchmarks for a triage test. However, Xpert-MTB-HR was highly sensitive in detecting individuals with medium or high sputum bacillary burden.FundingNational Institutes of Health (R01 AI130058 and R01 AI149620) and Brazilian National Council for Scientific and Technological Development (CNPq-404182/2019-4). Xpert-MTB-HR cartridges were provided by Cepheid.


2017 ◽  
Vol 2 (20;2) ◽  
pp. s135-s145 ◽  
Author(s):  
Nebojsa Nick Knezevic

Background: Even though serious efforts have been undertaken by different medical societies to reduce opioid use for treating chronic benign pain, many Americans continue to seek pain relief through opioid consumption. Assuring compliance of these patients may be a difficult aspect of proper management even with regular behavioral monitoring. Objective: The purpose of this study was to accurately assess the compliance of chronic opioidconsuming patients in an outpatient setting and evaluate if utilizing repeated urine drug testing (UDT) could improve compliance. Study Design: Retrospective analysis of prospectively collected data. Setting: Outpatient pain management clinic. Methods: After Institutional Review Board (IRB) approval, a retrospective analysis of data for 500 patients was conducted. We included patients who were aged 18 years and older who were treated with opioid analgesic medication for chronic pain. Patients were asked to provide supervised urine toxicology specimens during their regular clinic visits, and were asked to do so without prior notification. The specimens were sent to an external laboratory for quantitative testing using liquid chromatography-tandem mass spectrometry. Results: Three hundred and eighty-six (77.2%) patients were compliant with prescribed medications and did not use any illicit drugs or undeclared medications. Forty-one (8.2%) patients tested positive for opioid medication(s) that were not prescribed in our clinic; 8 (1.6%) of the patients were positive for medication that was not prescribed by any physician and was not present in the Illinois Prescription Monitoring Program; 5 (1%) patients tested negative for prescribed opioids; and 60 (12%) patients were positive for illicit drugs (8.6% marijuana, 3.2% cocaine, 0.2% heroin). Repeated UDTs following education and disclosure, showed 49 of the 77 patients (63.6%) had improved compliance. Limitations: This was a single-site study and we normalized concentrations of opioids in urine with creatinine levels while specific gravity normalization was not used. Conclusions: Our results showed that repeated UDT can improve compliance of patients on opioid medications and can improve overall pain management. We believe UDT testing should be used as an important adjunctive tool to help guide clinical decision-making regarding opioid therapy, potentially increasing future quality of care. Key words: Urine toxicology analysis, chronic pain, opioids, compliance, pain management, urine drug testing, urine drug screening


2012 ◽  
Vol 3S;15 (3S;7) ◽  
pp. ES119-ES133
Author(s):  
Allen W. Burton

Background: The precise role of urine drug testing (UDT) in the practice of pain medicine is currently being defined. Confusion exists as to best practices, and even to what constitutes standard of care. A member survey by our state pain society revealed variability in practice and a lack of consensus. Objective: The authors sought to further clarify the importance of routine UDT as an important part of an overall treatment plan that includes chronic opioid prescribing. Further, we wish to clarify best practices based on consensus and data where available. Methods: A 20-item membership survey was sent to Texas Pain Society members. A group of chronic pain experts from the Texas Pain Society undertook an effort to review the best practices in the literature. The rationale for current UDT practices is clarified, with risk management strategies outlined, and recommendations for UDT outlined in detail. A detailed insight into the limitations of point-of-care (enzyme-linked immunosorbent assay, test cups, test strips) versus the more sensitive and specific laboratory methods is provided. Limitations: Our membership survey was of a limited sample size in one geographic area in the United States and may not represent national patterns. Finally, there is limited data as to the efficacy of UDT practices in improving compliance and curtailing overall medication misuse. Conclusions: UDT must be done routinely as part of an overall best practice program in order to prescribe chronic opioid therapy. This program may include risk stratification; baseline and periodic UDT; behavioral monitoring; and prescription monitoring programs as the best available tools to monitor chronic opioid compliance. Key words: Urine drug screening, urine toxicology screening, urine drug testing, chronic pain, addiction, forensic testing


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