Immunalysis Corporation

Pomona, CA, United States

Immunalysis Corporation

Pomona, CA, United States
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Moore C.,Immunalysis Corporation | Crouch D.,Utah Toxicology Expert Services LLC
Bioanalysis | Year: 2013

The utility of oral fluid as a sample matrix for the analysis of drugs has been increasing in popularity over the last few years. This is largely because of collection advantages over other matrices, but also due to the rapid improvements in analytical assays including highly sensitive liquid reagent format enzyme immunoassays and LC-MS/MS. This review will highlight improvements in assay formats, sensitivity, laboratory equipment and sample processing using low sample volumes to expand drug test profiles. © 2013 Future Science Ltd.


Garnier M.,Immunalysis Corporation | Coulter C.,Immunalysis Corporation | Moore C.,Immunalysis Corporation
Journal of Analytical Toxicology | Year: 2011

A retrospective analysis of data from oral fluid specimens was conducted in order to identify a relevant cutoff concentration for opiates and/or synthetic opiates in oral fluid. Previously proposed regulations from the Substance Abuse and Mental Health Services Administration (SAMHSA) have recommended 40 μg/L as a cutoff concentration. In this study, data from oral fluid specimens collected using the Quantisal™ device and screened with enzyme linked immunosorbent assays (ELISA) for both opiates and oxycodone were retrospectively assessed for screen positives > 20 μg/L and those between negative and 20 μg/L. Specimens identified at these concentrations were then analyzed using liquid chromatography with tandem mass spectral detection using a fully validated procedure. Overall, 156 positive specimens were identified using 40 μg/L; 191 specimens using 20 μg/L; and 241 specimens between negative and 20 μg/L. Specifically, the number of 6-acetylmorphine (6-AM) positives increased from 10 to 16; morphine 4 to 9; codeine from 11 to 19; oxycodone from 56 to 74; hydrocodone from 73 to 119; and hydromorphone from 2 to 4 when specimens with enzyme inhibition between negative and 20 μg/L were analyzed. For workplace testing where only codeine, morphine, and 6-AM are considered, the use of a lowered cutoff concentration produced significant increases in the positive rate.


Coulter C.,Immunalysis Corporation | Garnier M.,Immunalysis Corporation | Moore C.,Immunalysis Corporation
Journal of Analytical Toxicology | Year: 2011

At the end of 2010, the U.S. Drug Enforcement Administration (DEA) used its emergency scheduling authority to temporarily control five chemicals, JW-H-018, JWH-073, JWH-200, CP-47497, and cannabicyclohexanol (CP-47497 C8), often referred to as "Spice", K2, or "synthetic cannabinoids" because of their reported cannabis-like effects. JWH-250 is commonly encountered, and HU-210 was already controlled, so these were also included in the research.We report the first analytical procedure for the simultaneous determination of these compounds in oral fluid specimens collected with the QuantisalTM™ device using solid-phase extraction and liquid chromatography with tandem mass spectrometry. The method was validated and applied to specimens taken from two individuals who had purchased the synthetic compounds while still legally available in the U.S. After a single session of smoking "Blueberry Posh", the peak concentration of JWH-018 detected was 35 μg/L 20 min after smoking; JWH-018 was still detectable 12 h after a single intake. After a single session of smoking "Black Mamba", JWH-018 was detected with a peak concentration of 5 μg/L after 20 min. In this subject, the compound was not detectable after 12 h.


Kelley-Baker T.,Pacific Institute for Research and Evaluation | Moore C.,Immunalysis Corporation | Lacey J.H.,Pacific Institute for Research and Evaluation | Yao J.,Pacific Institute for Research and Evaluation
Traffic Injury Prevention | Year: 2014

Objective: The National Roadside Survey is a study undertaken in the United States to determine the prevalence of alcohol and drugs in randomly selected drivers. Following the success of a 2006 pilot study, the 2007 survey incorporated, for the first time, the collection of biological specimens for drug analysis. This article compares the results obtained from blinded analyses of pairs of oral fluid and blood samples obtained from the same subject. Methods: During the 2007 survey, more than 7000 nighttime drivers were randomly stopped and surveyed for their self-reported drug use and were requested to donate an oral fluid specimen using the Quantisal (Immunalysis Corporation, Pomona, CA) device and a blood sample. Overall, 5869 oral fluid specimens were collected from nighttime drivers with 3236 corresponding blood samples. Results: Biological specimens were analyzed for a wide range of drugs. At nighttime, 14.4 percent of the drivers were positive for drugs in oral fluid, with just over half of those having marijuana present (7.6%). Of the 3236 pairs of specimens, 2676 were negative for all drugs, and 326 matched pairs of samples were both positive, out of which 247 (75.8%) were an exact match for all drug classes and 70 (21.5%) were positive for at least one common drug class. Conclusions: Oral fluid and blood samples provided very similar information regarding recent drug intake by randomly tested drivers and oral fluid yielded a higher detection rate for one drug (cocaine) than blood. Oral fluid can be considered a reliable alternative to blood as a matrix for drug testing. © 2014 Copyright Taylor and Francis Group, LLC.


Coulter C.,Immunalysis Corporation | Garnier M.,Immunalysis Corporation | Moore C.,Immunalysis Corporation
Journal of Analytical Toxicology | Year: 2012

This paper describes the determination of tetrahydrocannabinol (THC) and its metabolite, 11-nor-D9-tetrahydrocannabinol-Δ9-carboxylic acid (THC-COOH) in oral fluid using solid-phase extraction and liquid chromatography with tandem mass spectral detection (LC-MS-MS) and its application to proficiency specimens. The method employs collection of oral fluid with the Quantisal™ device, base hydrolysis, solid-phase extraction and LC-MS-MS in positive ion electrospray mode. Because the concentration of the metabolite in oral fluid is quite low, extremely sensitive analytical methods are necessary. The requisite sensitivity was achieved by a simple, rapid derivatization of the compound after extraction. The derivatization conditions did not affect parent THC. The method was fully validated using standard parameters including linearity, sensitivity, accuracy, intra-day and inter-day imprecision, drug recovery from the collection pad, limit of quantitation, limit of detection and matrix effects. The procedure was applied to oral fluid proficiency specimens previously analyzed to assess the stability of THC-COOH. © The Author [2012]. Published by Oxford University Press. All rights reserved.


Moore C.,Immunalysis Corporation | Kelley-Baker T.,Pacific Institute for Research and Evaluation | Lacey J.,Pacific Institute for Research and Evaluation
Journal of Opioid Management | Year: 2012

Objective: The purpose of this retrospective study was to compare oxycodone concentrations in saliva and whole blood with a view to propose therapeutic concentrations in oral fluid. Oral fluid is an easy specimen to collect with several advantages over urine, including ease of collection and difficulty of adulteration. As oral fluid is a reflection of free drug circulating in the blood, drug concentrations in saliva are more closely related to blood levels than urine concentrations. The number of testing laboratories offering the analysis of prescription pain medications in urine has increased significantly over the last few years, along with the overuse and abuse of pain killing drugs, specifically oxycodone. Hence, the utility of oral fluid analysis in this field was assessed. Design: Paired specimens of blood and oral fluid were retrospectively studied in an attempt to establish a range for oxycodone concentrations in oral fluid reflective of therapeutic intake. Twenty-three paired oral fluid-blood specimens were studied. Oral fluid samples had been collected with the Quantisal™ oral fluid device, stored cold and shipped overnight to the laboratory prior to testing. Blood specimens were collected simultaneously in gray top tubes. Results: From 23 pairs of samples, the median concentration in oral fluid was 524 μg/L and blood was 53 μg/L. The whole blood to plasma ratio for oxycodone was 1.3, so the median plasma concentration was 41 μg/L projecting a saliva to plasma ratio (S:P ratio) of 12. The comparison of oral fluid-blood concentrations allowed the projection of a S:P ratio for oxycodone and the development of a potential therapeutic range for oxycodone in oral fluid. Conclusion: Saliva drug concentrations in pain management are more closely related to blood levels than urine so can be more easily interpreted. These data provide a foundation for interpretative advances; however, further research surrounding other pain medications and controlled studies are necessary. © 2012 Journal of Opioid Management, All Rights Reserved.


Agius R.,Labor Krone | Nadulski T.,Labor Krone | Moore C.,Immunalysis Corporation
Forensic Science International | Year: 2012

LUCIO ®-Direct-enzyme linked immunosorbent assay (ELISA) tests were validated for the screening of drugs of abuse cannabis, opiates, amphetamines and cocaine in urine for the new German medical and psychological assessment (MPA) guidelines with subsequent gas chromatographic-mass spectrometric (GC-MS) confirmation. The screening cut-offs corresponding to 10ng/mL 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid (THC-COOH), 50ng/mL amphetamine, 25ng/mL morphine and codeine and 30ng/mL benzoylecgonine were chosen at the point where the number of false negatives was lower than 1%. Due to their accuracy, ease of use and rapid analysis, these ELISA tests are very promising for cases where a large proportion of the tests are expected to be negative such as for abstinence monitoring as part of the driving licence re-granting process. © 2011 Elsevier Ireland Ltd.


Moore C.,Immunalysis Corporation
Journal of Opioid Management | Year: 2015

A review of the utility of oral fluid in drug testing and adherence monitoring in pain management is presented. The article includes a description of the "State of the Art"; drug deposition; advantages and drawbacks of oral fluid testing; and overall related literature. © 2015 Journal of Opioid Management, All Rights Reserved.


Tuyay J.,Immunalysis Corporation | Coulter C.,Immunalysis Corporation | Rodrigues W.,Immunalysis Corporation | Moore C.,Immunalysis Corporation
Drug Testing and Analysis | Year: 2012

The use of prescription pain relievers, specifically opioids, has been increasing over the last few years. Oral fluid is easier to collect than urine, is difficult to adulterate, and is a reflection of free drug in the body, so its analysis is becoming more widespread in the monitoring of opioids. The demethylated metabolites of oxycodone, hydrocodone, and codeine are present at higher concentrations in oral fluid than oxymorphone, hydromorphone, and morphine, respectively; therefore, their detection in saliva indicates ingestion of the medication rather than diversion, and should be included in the analysis of opioids in this matrix. Since the compounds have the same nominal molecular weights, the same M+H + precursor ions in positive electrospray mode, and potentially identical collisionally activated fragmentation patterns, the importance of chromatography to separate the various opioids as well as the selection of mass spectral transitions is critical for correct identification. A procedure for the simultaneous determination of 12 opioid related compounds in oral fluid using liquid chromatography with tandem mass spectrometry (LC-MS/MS) is presented. The recovery of opioids from the collection device was over 80% at 20ng/ml; intra-day imprecision was less than 6.8%; inter-day imprecision less than 6.2%. In authentic specimens, the predominant metabolite of oxycodone was noroxycodone; for specimens containing codeine, no morphine was detected; and for hydrocodone positives, norhydrocodone was detected at significantly higher levels than hydromorphone. The importance of monitoring specific mass spectral transitions and chromatographic separation is demonstrated. © 2012 John Wiley & Sons, Ltd.


Moore C.,Immunalysis Corporation
Drug Testing and Analysis | Year: 2011

Workplace drug testing programs have embraced both oral fluid and hair as testing matrices. Saliva is popular due to its easy, rapid collection; its non-invasiveness compared to urine or blood; the convenience of collecting a specimen anywhere, anytime; and the difficulty of adulteration. The main advantage of saliva, however, remains its suitability for post-accident or 'for-cause' testing since the presence of a parent drug can assist in the determination of an individual being 'under the influence' of a drug. Hair, on the other hand, is useful for workplace programs, since its ability to provide historical information on drug intake ensures it is an excellent specimen for pre-employment testing. Both technologies have enjoyed collection and laboratory improvements for immunoassay screening over the last few years, and these are discussed in this perspective. Copyright © 2010 John Wiley & Sons, Ltd.

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