scholarly journals Immunoassay-Based Drug Tests Are Inadequately Sensitive for Medication Compliance Monitoring in Patients Treated for Chronic Pain

10.36076/se9 ◽  
2017 ◽  
Vol 2 (20;2) ◽  
pp. sE1-sE9 ◽  
Author(s):  
Stacy Melanson
Keyword(s):  
Mass Spectrometry ◽  
Chronic Pain ◽  
Pain Management ◽  
Drug Use ◽  
Illicit Drugs ◽  
False Negative ◽  
The United States ◽  
Enzyme Immunoassays ◽  
Negative Results ◽  
False Negative Results

Background: Enzyme immunoassays (EIA) have notable limitations for monitoring therapeutic compliance in pain management. Chromatography coupled with mass spectrometry provides definitive results and superior sensitivity and specificity over traditional EIA testing. Objective: To analyze and compare the sensitivity of EIA results together with known prescriptions to liquid chromatography-tandem mass spectrometry (LC-MS/MS) for monitoring drug use (and abuse) in patients treated for chronic pain. Study Design: A total of 530 urine samples from patients being treated for chronic pain were studied. Setting: Pain management clinic in the United States. Methods: The samples were tested for a profile of chronic pain medications and illicit drugs with commercially available EIA kits followed by analysis with Agilent LC-MS/MS system. Results: The EIAs exhibited poor sensitivity and high rates of false negative results in the pain management setting. For example, 21% of EIA for opiates show false negative results. Mass spectrometry methods were more sensitive, detected a broader range of drugs and metabolites, and could detect non-prescribed drug use and simulations in compliance. Limitations: Patients do not always accurately report drug use information, and some drugs do not have EIA methods available for comparative purposes. Conclusions: Mass spectrometry is a more robust and reliable method for detection of drugs used in the pain management setting. Due to the extent of undisclosed use and abuse of medications and illicit drugs, LC-MS/MS testing is necessary for adequate and accurate drug detection. In addition, LC-MS/MS methods are superior in terms of sensitivity and number of compounds that can be screened, making this a better method for use in pain management. Key words: Pain management, enzyme immunoassays, mass spectrometry, urine drug testing, prescription status, compliance

scholarly journals An Evaluation of the Diagnostic Accuracy of Liquid Chromatography-Tandem Mass Spectrometry Versus Immunoassay Drug Testing in Pain Patients

2010 ◽  
Vol 3;13 (3;5) ◽  
pp. 273-281
Author(s):  
Cameron West
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
Diagnostic Accuracy ◽  
Illicit Drugs ◽  
Illicit Drug ◽  
False Negative ◽  
Negative Results ◽  
False Negative Results ◽  
Liquid Chromatography Tandem Mass ◽  
Pain Patients

Background: Immunoassay screening is used by pain physicians to determine compliance with controlled substances. Because clinical use of pain medications is different from illicit drug use, there is a need to evaluate the level of diagnostic accuracy of this procedure for the pain patient. Objective: To compare the results of automated screening by immunoassay with analysis by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) in identifying pain patients using illicit drugs and pain patients excreting low concentrations of their prescribed medications. Study Design: A diagnostic accuracy study. Methods: Urine samples from 4,200 pain patients were tested by immunoassay and LCMS/MS for the following drugs and metabolites: Amphetamine, Methamphetamine, Alphahydroxyalprazolam, Lorazepam, Nordiazepam, Oxazepam, Temazepam, Cannabinoids, Cocaine, Methadone, Methadone Metabolite, Codeine, Hydrocodone, Hydromorphone, Morphine, Propoxyphene, and Norpropoxyphene. Results: In a number of patients negative immunoassay findings were superseded by positive results on analysis by Mass Spectrometry. These were termed false negative results. The greatest failures were for the benzodiazepines (28%) and for cocaine (50%). Limitations: The study was limited by the lack of complete demographics for the cohort and because only one immunoassay diagnostic product was used. It was also limited because not all drugs react the same in the immunoassay. Conclusions: We show that in general, immunoassay screening results are accurate, although as shown in this study there are many false negative observations. The use of LC-MS/MS technology significantly decreases the number of false negative results. Key words: Drug abuse, illicit drug use, opioids, illicit drugs, benzodiazepines, false negatives, liquid chromatography-mass spectrometry, immunoassay, adherence monitoring

scholarly journals Superiority of MALDI-TOF Mass Spectrometry over Real-Time PCR for SARS-CoV-2 RNA Detection

Viruses ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 730
Author(s):  
Magda Rybicka ◽  
Ewa Miłosz ◽  
Krzysztof Piotr Bielawski
Keyword(s):  
Mass Spectrometry ◽  
Gold Standard ◽  
Viral Genome ◽  
False Negative ◽  
Rt Pcr ◽  
Rna Detection ◽  
Maldi Tof ◽  
Negative Results ◽  
False Negative Results ◽  
Pcr Test

At present, the RT-PCR test remains the gold standard for early diagnosis of SARS-CoV-2. Nevertheless, there is growing evidence demonstrating that this technique may generate false-negative results. Here, we aimed to compare the new mass spectrometry-based assay MassARRAY® SARS-CoV-2 Panel with the RT-PCR diagnostic test approved for clinical use. The study group consisted of 168 suspected patients with symptoms of a respiratory infection. After simultaneous analysis by RT-PCR and mass spectrometry methods, we obtained discordant results for 17 samples (10.12%). Within fifteen samples officially reported as presumptive positive, 13 were positive according to the MS-based assay. Moreover, four samples reported by the officially approved RT-PCR as negative were positive in at least one MS assay. We have successfully demonstrated superior sensitivity of the MS-based assay in SARS-CoV-2 detection, showing that MALDI-TOF MS seems to be ideal for the detection as well as discrimination of mutations within the viral genome.

scholarly journals Patterns of Marijuana Use in a 6-Month Pain Management Sample in the United States

2017 ◽  
Vol 11 ◽  
pp. 117822181772478 ◽  
Author(s):  
Hope M Smiley-McDonald ◽  
Katherine N Moore ◽  
David C Heller ◽  
Jeri D Ropero-Miller ◽  
Gregory L McIntire ◽  
...  
Keyword(s):  
Pain Management ◽  
Drug Use ◽  
Prescription Drugs ◽  
Drug Testing ◽  
Illicit Drugs ◽  
Marijuana Use ◽  
The United States ◽  
Prescription Drug Use ◽  
Urine Drug Testing ◽  
Urine Drug

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.

False-positive and false-negative rates in meconium drug testing

1995 ◽  
Vol 41 (11) ◽  
pp. 1614-1616 ◽  
Author(s):  
C Moore ◽  
D Lewis ◽  
J Leikin
Keyword(s):  
Mass Spectrometry ◽  
False Positive ◽  
Drug Testing ◽  
False Positive Rate ◽  
False Negative ◽  
Gas Chromatography Mass Spectrometry ◽  
Negative Results ◽  
False Negative Results ◽  
The Matrix ◽  
Positive Rate

Abstract To determine the number of false-negative results produced by inefficient extraction of drugs from meconium, three published procedures were compared by using previously confirmed positive and negative meconium specimens. The methods were not equivalent in their ability to extract drugs from the matrix. To determine the number of false positives reported by the use of screen-only (unconfirmed) results, 535 screen-positive meconium specimens were subjects to confirmation by gas chromatography-mass spectrometry. Fifty-seven percent of the samples were confirmed positive for one or more of the drugs under investigation, showing that a false-positive rate as high as 43% may exist when unconfirmed screening results are used.

scholarly journals Validation, Optimization, and Application of the Zebrafish Developmental Toxicity Assay for Pharmaceuticals Under the ICH S5(R3) Guideline

2021 ◽  
Vol 9 ◽  
Author(s):  
Yi-Sheng Song ◽  
Ming-Zhu Dai ◽  
Chen-Xia Zhu ◽  
Yan-Feng Huang ◽  
Jing Liu ◽  
...  
Keyword(s):  
Developmental Toxicity ◽  
False Negative ◽  
Toxicity Testing ◽  
The United States ◽  
Toxicity Assay ◽  
Negative Results ◽  
False Negative Results ◽  
Developmental Toxicity Testing ◽  
Classical Protocol

The zebrafish as an alternative animal model for developmental toxicity testing has been extensively investigated, but its assay protocol was not harmonized yet. This study has validated and optimized the zebrafish developmental toxicity assay previously reported by multiple inter-laboratory studies in the United States and Europe. In this study, using this classical protocol, of 31 ICH-positive compounds, 23 compounds (74.2%) were teratogenic in zebrafish, five had false-negative results, and three were neither teratogenic nor non-teratogenic according to the protocol standard; of 14 ICH-negative compounds, 12 compounds (85.7%) were non-teratogenic in zebrafish and two had false-positive results. After we added an additional TI value in the zebrafish treated with testing compounds at 2 dpf along with the original 5 dpf, proposed a new category as the uncategorized compounds for those TI values smaller than the cutoff both at 2 dpf and 5 dpf but inducing toxic phenotypes, refined the testing concentration ranges, and optimized the TI cut-off value from ≥ 10 to ≥ 3 for compounds with refined testing concentrations, this optimized zebrafish developmental assay reached 90.3% sensitivity (28/31 positive compounds were teratogenic in zebrafish) and 88.9% (40/45) overall predictability. Our results from this study strongly support the use of zebrafish as an alternative in vivo method for screening and assessing the teratogenicity of candidate drugs for regulatory acceptance.

scholarly journals Reduced Diagnostic Performance of Two Norovirus Antigen Enzyme Immunoassays for the Emergent Genogroup II Genotype 17 Kawasaki 2014 Variant

2016 ◽  
Vol 54 (6) ◽  
pp. 1650-1652 ◽  
Author(s):  
Martin C. W. Chan ◽  
Kirsty Kwok ◽  
Tin-Nok Hung ◽  
Paul K. S. Chan
Keyword(s):  
Infection Control ◽  
Diagnostic Performance ◽  
Patient Management ◽  
False Negative ◽  
Enzyme Immunoassays ◽  
Negative Results ◽  
False Negative Results

Two commonly used norovirus enzyme immunoassays have reduced diagnostic performance, with clinical sensitivities ranging from 11% to 35% for the detection of the recently emerging genogroup II genotype 17 (GII.17) Kawasaki 2014 variant that caused the majority of infections in Asia during the winter of 2014 to 2015. False-negative results can compromise infection control and patient management.

scholarly journals A Prospective Evaluation of Psychotherapeutic and Illicit Drug Use in Patients Presenting with Chronic Pain at the Time of Initial Evaluation

2013 ◽  
Vol 1;16 (1;1) ◽  
pp. E1-E13
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Chronic Pain ◽  
Pain Management ◽  
Drug Use ◽  
Primary Care Physicians ◽  
Illicit Drug ◽  
Illicit Drug Use ◽  
The United States ◽  
Interventional Pain Management ◽  
High Doses ◽  
Noncancer Pain

Background: Reports of chronic pain and associated opioid use, abuse, and fatalities continue to increase at an alarming rate, not only in the United States but also across the globe. In light of the many resultant fatalities, multiple authors and authorities have cautioned against the excessive use of opioids. Consequently, the Food and Drug Administration, Drug Enforcement Administration, and multiple state authorities have been proposing and implementing a plethora of regulations to curb opioid overuse and abuse. In the majority of cases, pain physicians have been portrayed as the perpetrators responsible for escalating use and abuse and resultant fatalities. Objectives: To assess the patterns of psychotherapeutic drug use and illicit drug use at the time of initial evaluation. Study Design: A prospective evaluation. Setting: A private, specialty referral interventional pain management clinic in the United States. Methods: Participants were all new patients presenting to interventional pain management evaluated by one physician. Inclusion criteria was patients over 18 years of age with chronic spinal pain of at least one year duration. Results: The results of this evaluation indicate that 94% of patients were on long-term opioids prior to presenting to interventional pain management. Illicit drug use is also common, although it has declined significantly. While a large proportion of individuals (45.7%) have used illicit drugs at some point in the past, current illicit drug use is present in only 7.9% of patients, both past and current use are similar to that of the general population. More importantly, a significant proportion of patients have been on opioids (high doses of more than 40 mg equivalents of morphine 48.8%) on a long-term basis, initiated and maintained by primary care physicians, prior to presenting to interventional pain management. Further, 35% were on benzodiazepines, and 9.2% on carisoprodol prior to presenting to interventional pain management. Limitations: The limitations of this evaluation include that it is a prospective, single center evaluation by one physician that is partially dependent on subjective recall of the patient. Conclusion: This study shows an overwhelming majority of patients were initiated and maintained with opioids in managing chronic noncancer pain. They were frequently on high doses over a long period of time with multiple drug combinations prescribed by primary care physicians. Key Words: Chronic pain, persistent pain, noncancer pain, controlled substances, substance abuse, prescription drug abuse, opioids, prescriptions, urine drug testing, fatalities, regulations

Critical Evaluation of Impedance Phlebography for the Diagnosis of Deep Vein Thrombosis

1974 ◽  
Vol 31 (02) ◽  
pp. 273-278
Author(s):  
Kenneth K Wu ◽  
John C Hoak ◽  
Robert W Barnes ◽  
Stuart L Frankel
Keyword(s):  
Deep Vein Thrombosis ◽  
False Positive ◽  
False Negative ◽  
Critical Evaluation ◽  
Original Method ◽  
Vein Thrombosis ◽  
Negative Results ◽  
False Negative Results ◽  
Deep Vein ◽  
Positive Results

SummaryIn order to evaluate its daily variability and reliability, impedance phlebography was performed daily or on alternate days on 61 patients with deep vein thrombosis, of whom 47 also had 125I-fibrinogen uptake tests and 22 had radiographic venography. The results showed that impedance phlebography was highly variable and poorly reliable. False positive results were noted in 8 limbs (18%) and false negative results in 3 limbs (7%). Despite its being simple, rapid and noninvasive, its clinical usefulness is doubtful when performed according to the original method.

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