Method Validation of The Biochip Array Technology for Synthetic Cannabinoids Detection in Urine

Castaneto, Marisol S.; Desrosiers, Nathalie A.; Ellefsen, Kayla N.; Anizan, Sébastien; Martin, Thomas M.; Klette, Kevin L.; Huestis, Marilyn A.

doi:10.4155/bio.14.150

Cited by 18 publications

(12 citation statements)

References 24 publications

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“…Only two presumptive negative specimens confirmed positive for mCPP (3.3 μg/L) or BZP (3.6 μg/L), evidence that the assay has good sensitivity. Similar specificities and efficiencies also were observed with our two previous BAT evaluations with higher optimized cutoffs [14,17]. The best efficiency values for PNPII and BZP were achieved at cutoffs equal to ULOL, and the highest confirmation rate in our military cohort was achieved if specimens screened positive for all three antibodies.…”

Section: Discussionsupporting

confidence: 82%

“…We found only two commercially available designer piperazine-specific immunoassays, the BAT and Neogen enzyme-linked immunosorbent assay. When we evaluated the BAT synthetic cannabinoids and synthetic cathinones assays, confirmation rates in US service members' randomly collected urine specimens were 1.4 % [17] and 0.02 % [14], respectively. This was not surprising considering prohibition of NPS intake and significant penalties for positive results.…”

Section: Discussionmentioning

confidence: 99%

“…Immunoassay performance and cutoff optimization were evaluated according to a previous method [17]. Samples were considered true positive (TP) if the BAT immunoassay and LC-HRMS were positive and true negative (TN) if both results were negative.…”

Section: Discussionmentioning

confidence: 99%

“…Immunoassay analyses were performed on the Evidence EV180-120 analyzer (Randox LTD, Crumlin, UK) and operated according to our published study [17]. The DOA-V biochip is labeled with two PNP antibodies targeting mCPP and a third antibody targeting BZP.…”

Section: Instrumentationmentioning

confidence: 99%

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Biochip array technology immunoassay performance and quantitative confirmation of designer piperazines for urine workplace drug testing

et al. 2015

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Designer piperazines are emerging novel psychoactive substances (NPS) with few high-throughput screening methods for their identification. We evaluated a biochip array technology (BAT) immunoassay for phenylpiperazines (PNP) and benzylpiperazines (BZP) and analyzed 20,017 randomly collected urine workplace specimens. Immunoassay performance at recommended cutoffs was evaluated for PNPI (5 μg/L), PNPII (7.5 μg/L), and BZP (5 μg/L) antibodies. Eight hundred forty positive and 206 randomly selected presumptive negative specimens were confirmed by liquid chromatography high-resolution mass spectrometry (LC-HRMS). Assay limits of detection for PNPI, PNPII, and BZP were 2.9, 6.3, and 2.1 μg/L, respectively. Calibration curves were linear (R (2) > 0.99) with upper limits of 42 μg/L for PNPI/PNII and 100 μg/L for BZP. Quality control samples demonstrated imprecision <19.3 %CV and accuracies 86.0-94.5 % of target. There were no interferences from 106 non-piperazine substances. Seventy-eight of 840 presumptive positive specimens (9.3 %) were LC-HRMS positive, with 72 positive for 1-(3-chlorophenyl)piperazine (mCPP), a designer piperazine and antidepressant trazodone metabolite. Of 206 presumptive negative specimens, one confirmed positive for mCPP (3.3 μg/L) and one for BZP (3.6 μg/L). BAT specificity (21.1 to 91.4 %) and efficiency (27.0 to 91.6 %) increased, and sensitivity slightly decreased (97.5 to 93.8 %) with optimized cutoffs of 25 μg/L PNPI, 42 μg/L PNPI, and 100 μg/L BZP. A high-throughput screening method is needed to identify piperazine NPS. We evaluated performance of the Randox BAT immunoassay to identify urinary piperazines and documented improved performance when antibody cutoffs were raised. In addition, in randomized workplace urine specimens, all but two positive specimens contained mCPP and/or trazodone, most likely from legitimate medical prescriptions. Graphical Abstract Biochip array technology (BAT) immunoassay for designer piperazines detection in urine. In chemiluminescent immunoassay, the labeled-drug (antigen) competes with the drug in the urine. In the absence of drug, the labeled-drug binds to the antibody releasing an enzyme (horseradish peroxidase) to react with the substrate and producing chemiluminescence. The higher the drug concentration in urine, the weaker the chemiluminescent signal is produced. All presumptive positive specimens and randomly selected presumptive negative specimens were analyzed and confirmed by a liquid chromatography high-resolution mass spectrometry with limit of quantification of 2.5 or 5 μg/L.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Instrumentationmentioning

confidence: 99%

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Biochip array technology immunoassay performance and quantitative confirmation of designer piperazines for urine workplace drug testing

et al. 2015

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“…We found many FP screening results in the synthetic cannabinoid DOA-V assay at the manufacturer's suggested cutoffs, but when the optimal assay cutoff was determined by liquid chromatography-tandem mass spectrometry results, specificity and efficiency improved greatly. 40 For the synthetic cathinones, we also found many unconfirmed positive biochip array screening results compared with liquid chromatographytandem mass spectrometry confirmation. 41 However, we could not rule out instability of synthetic cathinones as a source of the FP screening results.…”

Section: Discussionmentioning

confidence: 93%

Urine Mescaline Screening With a Biochip Array Immunoassay and Quantification by Gas Chromatography–Mass Spectrometry

Battal

Barnes

Castaneto

et al. 2015

Therapeutic Drug Monitoring

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Mescaline, the primary psychoactive chemical in peyote cactus, has been consumed for thousands of years in ancient religious ceremonies. The US military wanted to determine if mescaline intake was a problem for personnel readiness. Twenty thousand seventeen urine specimens negative for cannabinoids, cocaine, opiates, and amphetamines were tested for mescaline with the Randox Drugs of Abuse V (DOA-V) biochip array immunoassay at the manufacturer's recommended cutoff of 6 mcg/L. A sensitive and specific method for mescaline quantification in urine was developed and fully validated. Extracted analytes were derivatized with pentafluoropropionic anhydride and pentafluoropropanol and quantified by gas chromatography-mass spectrometry (GC/MS) with electron impact ionization. Standard curves, using linear least squares regression with 1/x weighting, were linear from 1 to 250 mcg/L with coefficients of determination >0.994. Intra- and inter-assay imprecision was <4.4 coefficient of variation (%CV), with accuracies >90.4%. Mean extraction efficiencies were >92.0% across the linear range. This fully validated method was applied for the confirmation of urinary mescaline in 526 presumptive-positive specimens and 198 randomly selected presumptive-negative specimens at the manufacturer's 6 mcg/L cutoff. No specimen confirmed positive at the GC/MS limit of quantification of 1 mcg/L. Results indicated that during this time frame, there was insufficient mescaline drug use in the military to warrant routine screening in the drug testing program. However, mescaline stability, although assessed, could have contributed to lower prevalence. We also present a validated GC/MS method for mescaline quantification in urine for reliable confirmation of suspected mescaline intake.

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Immunoassays and Related Assays

2020

Fundamentals of Analytical Toxicology

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Method Validation of The Biochip Array Technology for Synthetic Cannabinoids Detection in Urine

Abstract: This high-throughput urine SC assay has good sensitivity and improved specificity and efficiency at modified cutoff concentrations.

Cited by 18 publications

References 24 publications

Biochip array technology immunoassay performance and quantitative confirmation of designer piperazines for urine workplace drug testing

Biochip array technology immunoassay performance and quantitative confirmation of designer piperazines for urine workplace drug testing

Urine Mescaline Screening With a Biochip Array Immunoassay and Quantification by Gas Chromatography–Mass Spectrometry

Immunoassays and Related Assays

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