Mark Hayward (Presenter)
ITSP Solutions
Bio: PhD Purdue - Mass Spectrometry - Cooks group 21 years in Pharma (Wyeth, Novartis, Lundbeck) - Primary role: Lab Operations Director for multiple labs globally focused on drug and biomarker measurement (US & EU) Currently: CSO ITSP Solutions - Primary role: delivering extraordinarily high performing methodology for the clinic that simultaneously achieves the simplest and most efficient work flows
Authorship: Mark Hayward,2 Rick Youngblood,2 Kim Gamble,2 Martin Johnson,1 Matthew T. Hardison1
1Assurance Scientific Laboratories, 727 Memorial Dr. Suite 103, Bessemer AL 35022 2ITSP Solutions Inc., 10 South Carolina St., Hartwell GA 30643
| Short Abstract Continued growth of LC/MS/MS for drugs of abuse in urine and OF seems certain. However, there are technical challenges that need to be met. These include easily measuring low dose drugs at or near 1 ng/g concentration (medical purposes, Pesce, 2012 AACC conf,& zero tolerance testing), simplicity performing measurements with lab technicians, and ability to achieve high productivity for all work while minimizing the labor and number of workflows required. To meet these needs, we have developed an automated on-line SPE-LC/MS/MS method. It uses SPE to clean / pre-concentrate samples so that low dose drugs at or near 1 ng/g concentration are easily measured at S/N ≥20. At the same time, the method’s design is balanced to address all of the drugs (acidic/basic drugs & polar / non-polar drugs), as well as urine and/or OF samples, all in one method, all in one workflow. |
Long Abstract
Measurement of drugs of abuse in urine and/or oral fluids (OF) is common for pre-employment screening, DOT / federal mandated testing, law enforcement, and compliance / diagnostic determinations by physicians (with the latter two growing rapidly). While a variety of methods are available for these measurements, the fastest growing & preferred approach is LC/MS/MS because of the high degree of certainty it provides for simultaneous determination of both identification and concentration of drugs. While continued growth of LC/MS/MS for the measurement of drugs of abuse in urine and OF seems certain, there are several technical challenges that need to be met. These needs include being able to easily measure low dose drugs at or near 1 ng/g concentration (for medical purposes, Pesce, et. al. 2012 AACC conference, as well as zero tolerance testing), simplicity for performing measurements with lab technicians, and the ability to achieve high productivity for all work while minimizing the labor and number of workflows required.
In an effort to meet these needs, we have developed an automated on-line SPE-LC/MS/MS method. It uses SPE to clean and pre-concentrate samples so that low dose drugs at or near 1 ng/g concentration are easily measured at S/N ≥20. The method’s design is balanced to address (identify / measure) all of the drugs (acidic and basic drugs as well as polar and non-polar drugs), as well as either urine or OF samples, all in one method, all in one workflow. Urine and OF samples even can be measured together on the same LC/MS/MS in the same run list. The method is simple, robust, and can be readily performed with a minimum amount of labor by lab technicians with MS familiarity. It is completely automated from sample plates/vials to results (with no change in work flow while still using only the native MS software) and can process two 96-well plates of samples overnight per LC/MS/MS. The results will be waiting for you in the morning.
Total automation is achieved using the PAL system LC autosampler which performs all sample preparation, including the SPE in parallel to LC/MS/MS analysis, & injects the sample into the LC/MS/MS. The cycle time achieved for on-line SPE-LC/MS/MS was 4.5 minutes for 71 drugs (opiates, metabolites, illicits, opioids, barbs, benzos, and THCA) in urine. The SPE methodology pre-concentrates the drugs so they are easily measured by the LC/MS/MS (high intensity, low background LC peaks) and high success rates are achieved for automatic integration of LC peaks. This allows the method to function well with any LC/MS/MS instrument (by simply adjusting sample volume loaded on SPE cartridge) and simultaneously allows highly proficient confirmation of low dose drugs (ca. 1 mg/day dosing) at <1 ng/g concentrations in oral fluids.
References & Acknowledgements:
| Description | Y/N | Source |
| Grants | no | |
| Salary | yes | ITSP Solutions |
| Board Member | no | |
| Stock | no | |
| Expenses | yes | ITSP Solutions |
IP Royalty: no
| Planning to mention or discuss specific products or technology of the company(ies) listed above: | yes |