Conclusion
Generally, the compounds tested with DBS test have shown promise. We, however, strongly recommend conducting validation and feasibility analysis prior to reporting results. As per FDA guidance, this validation should cover storage and handling temperature, homogeneity of DBS sample spotting, hematocrit, stability, carryover, and reproducibility including ISR[4]. Even more, concordance between DBS analysis and traditional plasma assays should be established if possible[5]. The most crucial point is ensuring the DBS test complies with the strict quality control (QC) guidelines for data accuracy, reliability, and consistency before relying on its results in conducting pharmacokinetic (PK) and bioanalytical studies.
NorthEast BioLab offers the following DBS sample services.
- Clinical LC-MS/MS method development, validation, and analysis
- Nonclinical LC-MS/MS bioanalytical support
- GLP toxicology method development, validation, and analysis
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[2] Grüner N, Stambouli O, Ross RS. Dried blood spots–preparing and processing for use in immunoassays and in molecular techniques. J Vis Exp. 2015 Mar 13;(97). doi: 10.3791/52619.
[3] Stove CP1, Ingels AS, De Kesel PM, Lambert WE. Dried blood spots in toxicology: from the cradle to the grave? Crit Rev Toxicol. 2012 Mar;42(3):230-43. doi: 10.3109/10408444.2011.650790.
[4] U.S. Food and Drug Administration, Guidance for Industry –
Bioanalytical Method Validation, September 2013 Biopharmaceutics Revision 1
[5] Neogi U, Gupta S, Rodridges R, Sahoo PN, Rao SD, Rewari BB, Shastri S, Costa AD, Shet A., Dried blood spot HIV-1 RNA quantification: a useful tool for viral load monitoring among HIV-infected individuals in India, Indian J Med Res. 2012 Dec;136(6):956-62