Recovery of Drugs of Abuse from Dräger DCD5000 Oral Fluid Collection Device in Australia

Abstract Background: Oral fluid (OF) is gaining prominence as an alternative matrix for monitoring drugs of abuse in the workplace, criminal justice, and driving under the influence of drugs programs. It is important to characterize assay performance and limitations of screening techniques for Δ9-tetrahydrocannabinol (THC) in OF. Methods: We collected OF specimens by use of the Quantisal™ OF collection device from 13 daily cannabis users after controlled oral cannabinoid administration. All specimens were tested with the Immunalysis Sweat/OF THC Direct ELISA and confirmed by 2-dimensional GC-MS. Results: The limit of detection was <1 μg/L THC equivalent, and the assay demonstrated linearity from 1 to 50 μg/L, with semiquantification to 200 μg/L. Intraplate imprecision (n = 7) ranged from 2.9% to 7.7% CV, and interplate imprecision (n = 20) was 3.0%–9.1%. Cross-reactivities at 4 μg/L were as follows: 11-hydroxy-THC, 198%; Δ8-tetrahydrocannabinol (Δ8-THC), 128%; 11-nor-9-carboxy-THC (THCCOOH), 121%; THC (target), 98%; cannabinol, 87%; THCCOOH-glucuronide, 11%; THC-glucuronide, 10%; and cannabidiol, 2.4%. Of 499 tested OF specimens, 52 confirmed positive (THC 2.0–290 μg/L), with 100% diagnostic sensitivity at the proposed Substance Abuse and Mental Health Services Administration screening cutoff of 4 μg/L cannabinoids and GC-MS cutoff of 2 μg/L THC. Forty-seven specimens screened positive but were not confirmed by 2D-GC-MS, yielding 89.5% diagnostic specificity and 90.6% diagnostic efficiency. Thirty-one of 47 unconfirmed immunoassay positive specimens were from 1 individual and contained >400 ng/L THCCOOH, potentially contributing to cross-reactivity. Conclusions: The Immunalysis Sweat/OF THC Direct ELISA is an effective screening procedure for detecting cannabinoids in OF.

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Development and validation of the Cozart® DDS oral fluid collection device

Forensic Science International ◽

10.1016/j.forsciint.2007.03.038 ◽

2007 ◽

Vol 170 (2-3) ◽

pp. 117-120 ◽

Cited By ~ 21

Author(s):

T. Speedy ◽

D. Baldwin ◽

G. Jowett ◽

M. Gallina ◽

A. Jehanli

Keyword(s):

Oral Fluid ◽

Fluid Collection ◽

Collection Device ◽

Development And Validation

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LC-MS/MS Validation for Drug of Abuse Testing Utilizing a Split Sample Oral Fluid Collection System.

10.26434/chemrxiv.13052360.v1 ◽

2020 ◽

Author(s):

Marissa Howard ◽

Paul Russo ◽

Amanda N Haymond ◽

Valerie Cruz Ortiz ◽

Sydney R Andes ◽

...

Keyword(s):

Oral Fluid ◽

Drugs Of Abuse ◽

Dynamic Range ◽

Limit Of Detection ◽

Fluid Collection ◽

Screening Method ◽

Confirmatory Test ◽

Sample Collection ◽

Laboratory Confirmation ◽

Split Sample

The Substance Abuse and Mental Health Services Administration (SAMHSA) recently authorized oral fluid (OF) as a preferable biofluid for drugs of abuse (DOA) screening compared to urine, and they required that each screening method be confirmed by a laboratory test. We developed a DOA mass spectrometry (MS) assay optimized for undiluted OF as a matching confirmatory test for the EZ-Saliva point of care (POC), split sample, rapid visual test. Using a double isotope ratio standardization, we achieved a limit of detection of <0.3 ng/mL for seven DOAs, with high precision in undiluted patient OF (CV<7.2%), linearity of R2 = 0.99, lack of interference (<1.0%) by a panel of interfering compounds at 1000-fold excess, and a dynamic range of 0-850 ng/mL, from a consented population of N=84 self-reported THC users using the collection device (device yield >90%). Stability from degradation exceeded 72 hours. The lateral flow immunoassay strips of the POC exhibited a dose-dependent response, with a 90% sensitivity and 100% specificity for N=22 self-reported, THC patient OF, digitized for quantitation. We conclude that the split sample POC device in combination with the MS assay meets the SAMHSA stated requirements for a POC test with a laboratory confirmation. Split sample collection has significant advantages because it minimizes potential error created by taking a separate OF sample for laboratory confirmation. We recommend scaling to a larger validation study set and quantification of user OF THC levels that correlate with driver impairment levels.

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Use of Oral Fluid in a Rapid Syphilis Test Assay

Open Forum Infectious Diseases ◽

10.1093/ofid/ofx163.107 ◽

2017 ◽

Vol 4 (suppl_1) ◽

pp. S107-S108 ◽

Cited By ~ 1

Author(s):

Chelsea Shannon ◽

Claire Bristow ◽

Sasha Herbst De Cortina ◽

Jennifer Chang ◽

Jeffrey Klausner

Keyword(s):

Whole Blood ◽

Oral Fluid ◽

Point Of Care ◽

Fluid Collection ◽

Treponema Pallidum ◽

Rapid Test ◽

High Sensitivity ◽

The United States ◽

Collection Device ◽

Positive Results

Abstract Background From 2014 to 2015, the syphilis rate in the United States increased by 19%, reaching its highest rate since 1994. Currently, point-of-care syphilis assays use fingerstick or venipuncture whole blood to identify Treponema pallidum (TP) antibodies by qualitative immunoassay. However, patients and providers prefer oral fluid testing to whole blood testing. In this study, we aimed to determine whether a rapid syphilis test intended for use on whole blood could be used to detect TP antibodies in oral fluid. Methods Oral fluid was collected from 72 participants using the Super•SAL™ Oral Fluid Collection Device (Oasis Diagnostics®, Vancouver, WA). The device uses an absorbent cylindrical pad to collect and filter ~1 mlml of oral fluid. Oral fluid filtrate was tested using the SD Bioline Syphilis 3.0 rapid test (Alere Diagnostics, MA) following manufacturer directions for whole blood. TP particle agglutination (TPPA) and rapid plasma reagin (RPR) results derived from participants’ medical records were used as reference values. We used three different definitions as comparators: 1: TPPA reactive; 2: TPPA and RPR reactive and 3: TPPA reactive and RPR titer >1:4. Those with non-reactive TPPA and RPR results were considered seronegative. We calculated the sensitivity and specificity for definition 1 and sensitivity for definitions 2 and 3. We used the exact binomial method to determine 95% confidence intervals (CI). Results With definitions 1, 2, and 3, respectively, sensitivity was 83.3% (CI: 67.2, 93.6), 86.4% (CI: 65.1, 97.1), and 100% (CI: 71.5, 100). Specificity was 47.2% (CI: 36.5, 75.5). Conclusion The high sensitivity of the SD Bioline Syphilis 3.0 test using oral fluid suggests a strong potential for the development of accurate rapid oral syphilis tests. Sensitivity increased with higher RPR titer. False positive results may be due to the presence of non-venereal treponemal antibodies in oral fluid. Further research and development are needed to optimize specificity. Disclosures All authors: No reported disclosures.

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Stability of Drugs of Abuse in Oral Fluid Collection Devices With Purpose of External Quality Assessment Schemes

Therapeutic Drug Monitoring ◽

10.1097/ftd.0b013e318198670b ◽

2009 ◽

Vol 31 (2) ◽

pp. 277-280 ◽

Cited By ~ 23

Author(s):

Montse Ventura ◽

Simona Pichini ◽

Rosa Ventura ◽

Sonia Leal ◽

Piergiorgio Zuccaro ◽

...

Keyword(s):

Quality Assessment ◽

Oral Fluid ◽

Drugs Of Abuse ◽

External Quality Assessment ◽

Fluid Collection ◽

External Quality

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LC-MS/MS Validation for Drug of Abuse Testing Utilizing a Split Sample Oral Fluid Collection System.

10.26434/chemrxiv.13052360 ◽

2020 ◽

Author(s):

Marissa Howard ◽

Paul Russo ◽

Amanda N Haymond ◽

Valerie Cruz Ortiz ◽

Sydney R Andes ◽

...

Keyword(s):

Oral Fluid ◽

Drugs Of Abuse ◽

Dynamic Range ◽

Limit Of Detection ◽

Fluid Collection ◽

Screening Method ◽

Confirmatory Test ◽

Sample Collection ◽

Laboratory Confirmation ◽

Split Sample

The Substance Abuse and Mental Health Services Administration (SAMHSA) recently authorized oral fluid (OF) as a preferable biofluid for drugs of abuse (DOA) screening compared to urine, and they required that each screening method be confirmed by a laboratory test. We developed a DOA mass spectrometry (MS) assay optimized for undiluted OF as a matching confirmatory test for the EZ-Saliva point of care (POC), split sample, rapid visual test. Using a double isotope ratio standardization, we achieved a limit of detection of <0.3 ng/mL for seven DOAs, with high precision in undiluted patient OF (CV<7.2%), linearity of R2 = 0.99, lack of interference (<1.0%) by a panel of interfering compounds at 1000-fold excess, and a dynamic range of 0-850 ng/mL, from a consented population of N=84 self-reported THC users using the collection device (device yield >90%). Stability from degradation exceeded 72 hours. The lateral flow immunoassay strips of the POC exhibited a dose-dependent response, with a 90% sensitivity and 100% specificity for N=22 self-reported, THC patient OF, digitized for quantitation. We conclude that the split sample POC device in combination with the MS assay meets the SAMHSA stated requirements for a POC test with a laboratory confirmation. Split sample collection has significant advantages because it minimizes potential error created by taking a separate OF sample for laboratory confirmation. We recommend scaling to a larger validation study set and quantification of user OF THC levels that correlate with driver impairment levels.

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Plasma and Oral Fluid Pharmacokinetics and Pharmacodynamics after Oral Codeine Administration

Clinical Chemistry ◽

10.1093/clinchem/48.9.1486 ◽

2002 ◽

Vol 48 (9) ◽

pp. 1486-1496 ◽

Cited By ~ 66

Author(s):

Insook Kim ◽

Allan J Barnes ◽

Jonathan M Oyler ◽

Raf Schepers ◽

Robert E Joseph ◽

...

Keyword(s):

Drug Administration ◽

Oral Fluid ◽

Drugs Of Abuse ◽

Solid Phase ◽

Subjective Effects ◽

Fluid Collection ◽

Plasma Concentrations ◽

Gas Chromatography Mass Spectrometry ◽

High Dose ◽

Detection Window

Abstract Background: The ease, noninvasiveness, and safety of oral fluid collection have increased the use of this alternative matrix for drugs-of-abuse testing; however, few controlled drug administration data are available to aid in the interpretation of oral fluid results. Methods: Single oral codeine doses (60 and 120 mg/70 kg) were administered to 19 volunteers. Oral fluid and plasma were analyzed for free codeine, norcodeine, morphine, and normorphine by solid-phase extraction combined with gas chromatography–mass spectrometry (SPE/GC-MS). Physiologic and subjective effects were examined. Results: Mean (SE) peak codeine concentrations were 214.2 ± 27.6 and 474.3 ± 77.0 μg/L in plasma and 638.4 ± 64.4 and 1599.3 ± 241.0 μg/L in oral fluid. The oral fluid-to-plasma ratio for codeine was relatively constant (∼4) from 1 to 12 h. The mean half-life (t1/2) of codeine was 2.2 ± 0.10 h in plasma and 2.2 ± 0.16 h in oral fluid. Significant dose-related miosis and increases in sedation, psychotomimetic effect, and “high” occurred after the high dose. Mean codeine oral fluid detection time was 21 h with a 2.5 μg/L cutoff, longer than that of plasma (12–16 h). Detection times with the proposed Substance Abuse and Mental Health Services Administration cutoff (40 μg/L) were only 7 h. Norcodeine, but not morphine or normorphine, was quantified in both plasma and oral fluid. Conclusions: The disposition of codeine over time was similar in plasma and oral fluid, but because of high variability, oral fluid codeine concentrations did not reliably predict concurrent plasma concentrations. Oral fluid testing is a useful alternative matrix for monitoring codeine exposure with a detection window of 7–21 h for single doses, depending on cutoff concentrations. These controlled drug administration data should aid in the interpretation of oral fluid codeine results.

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