Impact of Quantisal® Oral Fluid Collection Device on Drug Stability

The stability of drugs can affect drug tests and interpretations. A comprehensive study to verify drug stability in Quantisal® oral fluid (OF) collection device was undertaken in accordance with Australian standard, AS/NZS 4760:2019 (SAI-Global, 2019). The evaluation was performed for the following drugs: (±) amphetamine, (±) methylamphetamine, (±) 3,4-methylenedioxymethylamphetamine (MDMA), (−)Δ9-tetrahydrocannabinol (THC), cocaine, benzoylecgonine, morphine, codeine, and oxycodone. Stability was assessed at four different storage temperatures over seven time points at ±50% cut-off concentrations (Appendix A, Para A4-4.1, AS/NZS 4760:2019) (SAI-Global, 2019). All drugs were found to be significantly more stable at 4 and –20°C, with stability spanning at least 14 days with percentage change within ±20% from the cut-off concentrations (SAI-Global, 2019). In addition, we report a variation trend with cocaine and benzoylecgonine at elevated temperatures, suggesting hydrolytic decomposition of cocaine and a concomitant increase in benzoylecgonine quantitative values. We confirm the cross-talk by showing that the percentage change in the profile of average cocaine-benzoylecgonine measurement is within the acceptance concentration range of ±20%. This finding highlights the importance of precaution during storage and careful considerations during subsequent interpretation of liquid chromatography-mass spectrometry (LCMS) measurements.

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A comparison between the Intercept Oral Fluid Collection Device® and urinalysis among Baltimore City probationers

Journal of Criminal Justice ◽

10.1016/j.jcrimjus.2006.05.007 ◽

2006 ◽

Vol 34 (4) ◽

pp. 413-424 ◽

Cited By ~ 7

Author(s):

George S. Yacoubian ◽

Edward J. Cone

Keyword(s):

Oral Fluid ◽

Fluid Collection ◽

Baltimore City ◽

Collection Device

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Recovery of Drugs of Abuse from the Immunalysis Quantisal Oral Fluid Collection Device

Journal of Analytical Toxicology ◽

10.1093/jat/30.8.614 ◽

2006 ◽

Vol 30 (8) ◽

pp. 614-616 ◽

Cited By ~ 41

Author(s):

O. Quintela ◽

D. J. Crouch ◽

D. M. Andrenyak

Keyword(s):

Oral Fluid ◽

Drugs Of Abuse ◽

Fluid Collection ◽

Collection Device

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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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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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Detection of Drugs in Oral Fluid Samples Using a Commercially Available Collection Device: Agreement with Urine Testing and Evaluation of A and B Samples Obtained from Employees at Different Workplace Settings with Uncontrolled Sampling Procedures

Journal of Analytical Toxicology ◽

10.1093/jat/bkaa024 ◽

2020 ◽

Author(s):

Yufang Zheng ◽

Erik Sparve ◽

Stefan Sparring ◽

Mats Bergström

Keyword(s):

Oral Fluid ◽

Sampling Procedure ◽

Urine Samples ◽

Treatment Center ◽

Drug Detection ◽

Collection Device ◽

The Stability ◽

Sampling Procedures ◽

Urine Testing ◽

Testing And Evaluation

Abstract The use of oral fluid tests to detect drugs is of growing interest in various areas, including treatment centers, roadside and workplace testing. In this study, we investigated drug detection in oral fluid samples collected using a commercially available device, Oral Eze. Drug detection in oral fluid was compared to paired urine samples, which were simultaneously collected. We also evaluated the collection device by comparing A and B oral fluid samples. Finally, we studied the stability of various drugs in samples stored for at least 1 year. The drug profile was investigated by comparing the drugs detected in oral fluid samples with paired urine samples collected in a treatment center. A total of 113 paired oral fluid and urine samples were investigated for the presence of drugs in the following groups: amphetamines, benzodiazepines, opiates and opioids, cocaine and cannabis. A and B samples were collected from different workplaces through an uncontrolled sampling procedure (n = 76). The stability of drugs in A samples was assessed after storage at −20°C for 1 year. Generally, there was a good correlation between drugs detected in oral fluid samples and urine samples. The heroin metabolite, 6-MAM, was more frequently detected in oral fluid samples than in urine samples, while cannabis was better detected in urine samples. Drugs in oral fluid samples were stable when stored at −20°C for at least 1 year. However, in many positive A and B oral fluid samples, there was significant variation in the concentrations obtained. Hence, the collection device may need to be further standardized and improved.

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