Dataset Information

Development and Clinical Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the Emergency Department.

ABSTRACT:

Background

Rapid identification of fentanyl at the point-of-care is critical. Urine fentanyl concentrations in overdose cases start at single-digit nanograms per milliliter. No fentanyl point-of-care assay with a cutoff at single-digit nanograms per milliliter is available.

Methods

A competitive lateral flow assay (LFA) was developed using gold nanoparticles and optimized for rapid screening of fentanyl in 5?minutes. Urine samples from 2 cohorts of emergency department (ED) patients were tested using the LFA and LC-MS/MS. The 2 cohorts consisted of 218 consecutive ED patients with urine drug-of-abuse screen orders and 7 ED patients with clinically suspected fentanyl overdose, respectively.

Results

The LFA detected fentanyl (?1?ng/mL) and the major metabolite norfentanyl (?10?ng/mL) with high precision. There was no cross-reactivity with amphetamine, cocaine, morphine, tetrahydrocannabinol, methadone, buprenorphine, naloxone, and acetaminophen at 1000?ng/mL and 0.03%, 0.4%, and 0.05% cross-reactivity with carfentanil, risperidone, and 9-hydroxyrisperidone, respectively. In 218 consecutive ED patients, the prevalence of cases with fentanyl ?1?ng/mL or norfentanyl ?10?ng/mL was 5.5%. The clinical sensitivity and specificity of the LFA were 100% (95% CI, 75.8-100%) and 99.5% (95% CI, 97.3-99.9%), respectively. The positive and negative predictive values were 92.3% (95% CI, 66.7-98.6%) and 100% (95% CI, 98.2-100%), respectively. The concordance between the LFA and LC-MS/MS was 100% in the 7 suspected fentanyl overdose cases (5 positive, 2 negative).

Conclusions

The LFA can detect fentanyl and norfentanyl with high clinical sensitivity and specificity in the ED population with rapid fentanyl screening needs.

SUBMITTER: Li Z

PROVIDER: S-EPMC7161648 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Development and Clinical Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the Emergency Department.

Li Zhao Z Chen Hui H Feng Sheng S Liu Kengku K Wang Ping P

Clinical chemistry 20200201 2

<h4>Background</h4>Rapid identification of fentanyl at the point-of-care is critical. Urine fentanyl concentrations in overdose cases start at single-digit nanograms per milliliter. No fentanyl point-of-care assay with a cutoff at single-digit nanograms per milliliter is available.<h4>Methods</h4>A competitive lateral flow assay (LFA) was developed using gold nanoparticles and optimized for rapid screening of fentanyl in 5 minutes. Urine samples from 2 cohorts of emergency department (ED) patien ...[more]

PMID: 32040576

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Project description:BACKGROUND:Yersinia pestis is a contributing agent to the epidemic disease, plague, which killed an estimated 200 million people during historical times. In this study, a rapid, cheap, sensitive, and specific technique, the lateral flow assay (F1 strips), has been successfully developed to detect this pathogen, by using paired monoclonal antibodies (MAbs) against Y. pestis capsule like fraction 1 (F1) protein. Compared with the polyclonal antibody (PAb) based F1 strips, the Mab-based F1 strips have a remarkable increased detection limitation (10 to 100 folds). Furthermore, besides the limitation and specificity evaluation, the application of this F1 strip on simulated clinical samples indicate the LFA can be a good candidate to detect plague. METHODS:Recombinant F1 antigen was expressed and purified from a series of works. The various anti-F1 monoclonal antibodies generated from hybridoma cells were screened with the ELISA technique. To evaluate the feasibility of this Y. pestis F1 test strip, the F1 protein/Y. pestis was spiked into simulated clinical samples such as human serum, mouse bronchoalveolar lavage fluids, and mouse blood to mimic natural infection status. Additionally, this technique was applied to detect the Y. pestis in the environment-captured rats, to evaluate the practical usefulness of the strips. RESULTS:By using this MAb-based-LFA technique, 4 ng/ml of recombinant F1-protein and 103 CFU/ml of Y. pestis could be detected in less than 10 mins, which is at least 10-folds than that of the PAb format. On the other hand, although various Yersinia strains were applied to the strips, only Y. pestis strain showed a positive result; all other Yersinia species did not produce a positive signal, indicating the high efficiency and specificity of the MAb-based F1-strips. CONCLUSION:Based on our findings, we suggest that the MAb-format-LFA will be valuable as a diagnostic tool for the detection of Y. pestis. This report shows that the F1 strip is sufficient to support not only the detection of plague in simulated clinical samples, but also it may be a good candidate to meet the epidemiological surveillance during an outbreak of the biological warfare.

Project description:The Toronto Western Hospital is an academic hospital in Toronto, Canada, with an annual Emergency Department (ED) volume of 64,000 patients. Despite increases in patient volumes of almost six percent per annum over the last decade, there have been no commensurate increases in resources, infrastructure, and staffing. This has led to substantial increase in patient wait times, most specifically for those patients with lower acuity presentations. Despite requiring only minimal care, these patients contribute disproportionately to ED congestion, which can adversely impact resource utilization and quality of care for all patients. We undertook a retrospective evaluation of a quality improvement initiative aimed at improving wait times experienced by patients with lower acuity presentations. A rapid improvement event was organized by frontline workers to rapidly overhaul processes of care, leading to the creation of the Rapid Medical Evaluation (RME) unit - a new pathway of care for patients with lower acuity presentations. The RME unit was designed by re-purposing existing resources and re-assigning one physician and one nurse towards the specific care of these patients. We evaluated the performance of the RME unit through measurement of physician initial assessment (PIA) times and total length of stay (LOS) times for multiple groups of patients assigned to various ED care pathways, during three periods lasting three months each. Weekly measurements of mean and 90th percentile of PIA and LOS times showed special cause variation in all targeted patient groups. Of note, the patients seen in the RME unit saw their median PIA and LOS times decrease from 98min to 70min and from 165min to 130min, respectively, from baseline. Despite ever-growing numbers of patient visits, wait times for all patients with lower acuity presentations remained low, and wait times of patients with higher acuity presentations assigned to other ED care pathways were not adversely affected. By specifically re-purposing a fraction of existing staff, resources, and infrastructure for patients with lower acuity presentations, we were able to streamline their care and decrease wait times in the ED. These results were achieved through the incremental improvements afforded by rapidly cycling through PDSA cycles, with strong frontline staff involvement and continuously eliciting feedback for improvement. We believe the model to be replicable in other academic medical centres.

Project description:ObjectivesEmergency department (ED) crowding is an increasing problem associated with adverse patient outcomes. ED expansion is one method advocated to reduce ED crowding. The objective of this analysis was to determine the effect of ED expansion on measures of ED crowding.MethodsThis was a retrospective study using administrative data from two 11-month periods before and after the expansion of an ED from 33 to 53 adult beds in an academic medical center. ED volume, staffing, and hospital admission and occupancy data were obtained either from the electronic health record (EHR) or from administrative records. The primary outcome was the rate of patients who left without being treated (LWBT), and the secondary outcome was total ED boarding time for admitted patients. A multivariable robust linear regression model was used to determine whether ED expansion was associated with the outcome measures.ResultsThe mean (±SD) daily adult volume was 128 (±14) patients before expansion and 145 (±17) patients after. The percentage of patients who LWBT was unchanged: 9.0% before expansion versus 8.3% after expansion (difference = 0.6%, 95% confidence interval [CI] = -0.16% to 1.4%). Total ED boarding time increased from 160 to 180 hours/day (difference = 20 hours, 95% CI = 8 to 32 hours). After daily ED volume, low-acuity area volume, daily wait time, daily boarding hours, and nurse staffing were adjusted for, the percentage of patients who LWBT was not independently associated with ED expansion (p = 0.053). After ED admissions, ED intensive care unit (ICU) admissions, elective surgical admissions, hospital occupancy rate, ICU occupancy rate, and number of operational ICU beds were adjusted for, the increase in ED boarding hours was independently associated with the ED expansion (p = 0.005).ConclusionsAn increase in ED bed capacity was associated with no significant change in the percentage of patients who LWBT, but had an unintended consequence of an increase in ED boarding hours. ED expansion alone does not appear to be an adequate solution to ED crowding.

Dataset Information

Development and Clinical Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the Emergency Department.

Background

Methods

Results

Conclusions

Publications

Development and Clinical Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the Emergency Department.

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