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24 Buyers’ Guide 2021


bioanalytical assays typically have a guideline of <15 % RSD or <20% if at the LOD or LOQ level [12, 13, 14] to validate a method. This is a very important measure for a test in which you need confi dence in like an opioid test which can have large consequences for the patient who has been tested.


Figure 5 shows the % RSD of the recovery results. The data shows % RSD values ranging from 1.39% for morphine to 5.95% for EDDP. These fi gures show that the reproducibility of those 12 replicates are falling well within the typical suggested limits for % RSD guidelines often chosen for method validation.


Summary


Microlute™ CP SCX is able to detect a wide range of opioids in urine including natural, semi-synthetic and synthetic compounds making it the obvious choice for drugs of abuse analysis. The process of SPE allows for concentration of samples to allow for more sensitive analysis of lower concentration samples. This is not possible for ‘dilute and shoot’ methods due to the core principle of that method is to dilute down the sample. The Microlute™ CP SCX “microplate also offers advantageous recoveries across the range of different classes of opioids with high reproducibility <10 % RSD values. This ensures the product gives reliable and reproducible results which is an important metric in drugs testing where confi dence in the data output is required.


References:


1. Rosenblum, A., Marsch, L., Joseph, H. and Portenoy, R., 2008. Opioids and the treatment of chronic pain: Controversies, current status, and future directions. Experimental and Clinical Psychopharmacology, 16(5), pp.405-416.


2. European Monitoring Centre for Drugs and Drug Addiction, 2019. European Drug Report: Trends And Developments. [online] Available at: https://www.emcdda.europa.eu/system/ fi les/publications/11364/20191724_ TDAT19001ENN_PDF.pdf


3. Substance Abuse and Mental Health Services Administration (SAMHSA), 2018. Key Substance Use And Mental Health Indicators In The United States: Results From The 2018 National Survey On Drug Use And Health. [online] Available at: https://www.samhsa.gov/ data/sites/default/fi les/cbhsq-reports/ NSDUHNationalFindingsReport2018/ NSDUHNationalFindingsReport2018.pdf


4. Quest Diagnostics, 2018. Health Trends™ Drug Misuse In America 2018: Diagnostic Insights From Clinical Drug Monitoring Into The Opioid Epidemic. [online] Available at: https://www. questdiagnostics.com/dms/Documents/ drug-prescription-misuse/Health_Trends_ Report_2018.pdf


5. Mahajan, G., 2017. Role of Urine Drug Testing in the Current Opioid Epidemic. Anesthesia & Analgesia, 125(6), pp.2094- 2104.


6. Consensus Statement. Appropriate Use of Drug Testing in Clinical Addiction Medicine. Journal of Addiction Medicine, June 2017. [online] Available at: https://


www.asam.org/docs/default-source/ quality-science/appropriate_use_of_ drug_testing_in_clinical-1-(7).pdf


7. Dams, R., Murphy, C., Lambert, W. and Huestis, M., 2003. Urine drug testing for opioids, cocaine, and metabolites by direct injection liquid chromatography/ tandem mass spectrometry. Rapid Communications in Mass Spectrometry, 17(14), pp.1665-1670.


8. Edinboro, L.E., R.C. Backer, and A. Poklis, Direct Analysis of Opiates in Urine by Liquid Chromatography-Tandem Mass Spectrometry. Journal of Analytical Toxicology, 2005. 29(7): pp. 704-710.


9. Drugbank.ca. 2020. Drugbank. [online] Available at: https://www.drugbank.ca


10. Pubchem.ncbi.nlm.nih.gov. 2020. Pubchem. [online] Available at: https:// pubchem.ncbi.nlm.nih.gov/


11. Hmdb.ca. 2020. Human Metabolome Database. [online] Available at: https:// hmdb.ca


12. Food and Drug Administration (FDA), 2018. Bioanalytical Method Validation Guidance For Industry. [online] Available at: https://www.fda.gov/fi les/drugs/ published/Bioanalytical-Method- Validation-Guidance-for-Industry.pdf


13. European Medicines Agency (EMA), 2019. ICH Guideline M10 On Bioanalytical Method Validation. [online] Available at: https://www.ema.europa.eu/ en/documents/scientifi c-guideline/draft- ich-guideline-m10-bioanalytical-method- validation-step-2b_en.pdf


14. Karch, S., 2007. Workplace Drug Testing. Boca Raton, FL: CRC Press, p.67


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