NorthEast BioLab Logo | Advanced Bioanalytical Services Lab Agile Bioanalytical Services CRO
  • Expertise
    • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
    • Menu IconELISA Assay
      • Menu IconLuminex Multiplex Assay
    • Menu IconFlow Cytometry
    • Menu IconqPCR Analysis, ddPCR Assay
    • Menu IconWestern Blot, In Cell Western
  • Services
    • Menu IconAll Services
    • Menu IconPharmacokinetics (PK) Study
      • Menu IconToxicology (Tox) Study
      • Menu IconDose Formulation Analysis
      • Menu IconPK PD Analysis
      • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
      • Menu IconADME Studies
      • Menu IconBioequivalence and Bioavailability Studies
    • Menu IconADA Assay, Neutralizing Antibody Assay
    • Menu IconMultiplex Cytokine Assay
    • Menu IconBiomarker Assay
      • Menu IconBiomarker Assay List
    • Menu IconCell-Based Assay
      • Menu IconMechanism of Action (MOA) Studies
      • Menu IconCytotoxicity Assay
      • Menu IconBiochemical Assay
    • Menu IconBioanalytical Assay Validation
  • Solutions
    • Menu IconAll Solutions
    • Menu IconClinical CRO
      • Menu IconCentral Lab Services
      • Menu IconPBMC Services
    • Menu IconGLP Laboratory
      • Menu IconBioanalysis
      • Menu IconNon-GLP Testing
    • Menu IconPreclinical CRO
    • Menu IconMethod Development, Validation, And Transfer
      • Menu IconMethod Validation
      • Menu IconMethod Development
      • Menu IconMethod Transfer
    • Menu IconAnalytical Testing
      • Menu IconDiscovery Screening Services
      • Menu IconAnalytical Quantitation
      • Menu IconCosmetic Testing
  • About Us
    • Menu IconAbout Us
    • Menu IconOverview
    • Menu IconLeadership
    • Menu IconFacility and Equipment
    • Menu IconQuality and Compliance
    • Menu IconTherapeutic Areas
    • Menu IconWhy Us?
    • Menu IconValues
    • Menu IconProcess
    • Menu IconPartners
    • Menu IconCareers
      • Business Development Associate
      • Sr. Scientist – Cell Based Assay
      • GLP Quality Assurance Manager
      • Sr. Scientist, ELISA Immunoassay Bioanalysis
      • Sr. Scientist, LC-MS/MS Bioanalysis
      • Associate Scientist, Central Laboratory Services
      • Sr. Scientist - Pharmacokinetics (PK)
      • Content Manager, Scientific and Regulatory Writing
  • Resources
    • Menu IconLearning Center
    • Menu IconBlog
    • Menu IconCase Study
    • Menu IconVideo Brochures
    • Menu IconNews and Events
    • Menu IconTestimonials
    • Menu IconContact Us
  • Request Quote
NorthEast BioLab Logo | Advanced Bioanalytical Services Lab Agile Bioanalytical Services CRO Request Quote

Expertise

  • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
      • Menu IconELISA Assay
        • Menu IconLuminex Multiplex Assay
      • Menu IconFlow Cytometry
        • Menu IconqPCR Analysis, ddPCR Assay
          • Menu IconWestern Blot, In Cell Western

            Services

            • Menu IconAll Services
              • Menu IconPharmacokinetics (PK) Study
                • Menu IconToxicology (Tox) Study
                • Menu IconDose Formulation Analysis
                • Menu IconPK PD Analysis
                • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
                • Menu IconADME Studies
                • Menu IconBioequivalence and Bioavailability Studies
              • Menu IconADA Assay, Neutralizing Antibody Assay
                • Menu IconMultiplex Cytokine Assay
                  • Menu IconBiomarker Assay
                    • Menu IconBiomarker Assay List
                  • Menu IconCell-Based Assay
                    • Menu IconMechanism of Action (MOA) Studies
                    • Menu IconCytotoxicity Assay
                    • Menu IconBiochemical Assay
                  • Menu IconBioanalytical Assay Validation

                    Solutions

                    • Menu IconAll Solutions
                      • Menu IconClinical CRO
                        • Menu IconCentral Lab Services
                        • Menu IconPBMC Services
                      • Menu IconGLP Laboratory
                        • Menu IconBioanalysis
                        • Menu IconNon-GLP Testing
                      • Menu IconPreclinical CRO
                        • Menu IconMethod Development, Validation, And Transfer
                          • Menu IconMethod Validation
                          • Menu IconMethod Development
                          • Menu IconMethod Transfer
                        • Menu IconAnalytical Testing
                          • Menu IconDiscovery Screening Services
                          • Menu IconAnalytical Quantitation
                          • Menu IconCosmetic Testing

                        About Us

                        • Menu IconAbout Us
                          • Menu IconOverview
                            • Menu IconLeadership
                              • Menu IconFacility and Equipment
                                • Menu IconQuality and Compliance
                                  • Menu IconTherapeutic Areas
                                    • Menu IconWhy Us?
                                      • Menu IconValues
                                        • Menu IconProcess
                                          • Menu IconPartners
                                            • Menu IconCareers
                                              • Menu IconBusiness Development Associate
                                              • Menu IconSr. Scientist – Cell Based Assay
                                              • Menu IconGLP Quality Assurance Manager
                                              • Menu IconSr. Scientist, ELISA Immunoassay Bioanalysis
                                              • Menu IconSr. Scientist, LC-MS/MS Bioanalysis
                                              • Menu IconAssociate Scientist, Central Laboratory Services
                                              • Menu IconSr. Scientist - Pharmacokinetics (PK)
                                              • Menu IconContent Manager, Scientific and Regulatory Writing

                                            Resources

                                            • Menu IconLearning Center
                                              • Menu IconBlog
                                                • Menu IconCase Study
                                                  • Menu IconVideo Brochures
                                                    • Menu IconNews and Events
                                                      • Menu IconTestimonials
                                                        • Menu IconContact Us

                                                          Request Quote

                                                            Contact Us

                                                            • Home
                                                            • DBS Test, DBS Analysis, DBS Sample, DBS Sampling, DBS Collection

                                                            What Is Dried Blood Spot (DBS) Analysis?

                                                            Abhay Pandey | NorthEast BioLab
                                                            By Abhay Pandey, MBA
                                                            Reading Time: 4 minutes
                                                            DBS Test

                                                            Background

                                                            Dried blood spot (DBS) test has been practiced for ~100 years[1], but has started gaining traction as an alternate to traditional assays only this decade. Human / Animal blood is spotted on prepared filter cards, the cards are air dried, stored in airtight bags, and shipped under administered humidity and temperature levels[2] in DBS analysis. For bioanalytical analysis, we punch tiny discs out of the DBS and analyze them using a validated LC-MS/MS method. Traditionally, scientists have used DBS collection for preclinical studies, newborn screening, as well as DBS sample collection in resource-limiting settings. Recently, however, a variety of innovative DBS sampling applications have started to emerge. These DBS test applications include epidemiological surveys (e.g. HIV monitoring), therapeutic drug monitoring (TDM), as well as toxicology[3]. DBS tests can be useful at different stages, from the simplest research scenarios to very complex clinical cases, due to their simplicity and flexibility.

                                                            DBS Sample Collection

                                                            Benefits / Advantages

                                                            The primary advantages of the DBS test include lower sample volume collection and easier handling during DBS sample storage and transportation. Other seemingly less obvious advantages of DBS analysis are listed below.

                                                            • Nonclinical: Fewer animals, lower sample volume, less invasive sampling, and better data quality from serial DBS sampling as compared to composite samples
                                                            • Clinical: DBS Sampling preference of volunteer and clinical staff over venous cannula
                                                            • Bioanalytical: Minimal preparation, greater dry compound stability, and “Non-hazardous” classification post treatment of DBS cards
                                                            • Processing and shipping: Simpler DBS collection and transportation equipment

                                                            DBS Analysis

                                                            Study

                                                            We ran the study on an antiretroviral medicine, which is used in conjunction with other treatments for HIV. Due to cryo-freezers’ unavailability, it is generally difficult to properly collect, store, and maintain high-integrity blood samples in remote areas. The high shipping cost for transporting samples from these remote DBS collection sites to faraway sample analysis facilities was burdensome. Therefore, the investigators decided to use the DBS sampling technique. They collected each DBS sample at six spots for accurate/redundant DBS analysis.

                                                            Our team processed DBS samples, analyzed them using an LC-MS/MS method developed in our laboratory, and documented the DBS test results. We analyzed and compared results from each sample in five replicates. The observed coefficient of variation (CV) among these DBS samples was less than 7.2%, indicating the bioanalytical method as rugged and reproducible as well as the DBS collection process as accurate.

                                                            DBS Sampling Lab

                                                            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

                                                            [1] Hannon WH, Therell BL. Overview of the history and applications of dried blood spot samples. In: Li W, Lee MS, editors. Dried blood spots. Applications and techniques. Vol. 3. Hoboken: Wiley; 2014. pp. 3–15.

                                                            [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

                                                            Registered And Inspected By Various Regulatory Agencies

                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies
                                                            • Food and Drug Administration (FDA)
                                                            • Clinical Laboratory Improvement Amendments | NorthEast BioLab
                                                            • International Orgaization for Standardization |NorthEast BioLab
                                                            • DEA
                                                            • DOCP

                                                            Speak To Our Scientist About Your Dried Blood Spot (DBS) Sampling, DBS Collection, And DBS Analysis

                                                            SPEAK TO OUR SCIENTISTS

                                                            Similar Case Study Articles

                                                            • Inflammatory Biomarker Multiplex

                                                              Multiplex Cytokine Assay, GLP Cytokine Validation, Cytokine Quantification On MSD

                                                            • Humanized Monoclonal Antibody (MAb) PK ELISA Development, GLP Validation, And MAb Bioanalysis

                                                            • Oligonucleotide Hybridization ELISA PK Assay, GLP Validation, Sample Analysis

                                                            • TaqMan Gene Expression Assay, Copy Number Variation

                                                            • Genomic Variation Analysis – TaqMan Single Nucleotide Polymorphism (SNP) Analysis

                                                            • LC MS Bioanalysis Of Oligos Using Mass Spec And Ion Pair Chromatography

                                                            • Dosing THC Lab, Cannabis Testing Lab, CBD Melatonin Testing

                                                            • HPLC-UV Method Development: Testing 9 Articles in Formulation

                                                            • Payload Plus Peptide LC MS Analysis, GLP Validation In Rat, NHP, Human Plasma

                                                            • Epigallocatechin gallate (EGCG) LC MS Analysis In VcEDTA Human Serum

                                                            • LC MS Method For Proline Amino Acid, Hydroxyproline In Mouse Tissues

                                                            • LC MS Method For DNA Adducts Analysis In Cell-Based In-Vitro Samples

                                                            • LC MS Method for Everolimus Eluting Coronary Stent Drug Delivery Systems

                                                            • Mass Spectrometry Amino Acids, Quantitative LC MS Amino Acid Analysis

                                                            • LC MS Method Development And GLP Validation For PK Plasma Sample Analysis

                                                            • Incurred Sample Reanalysis (ISR) Test, FDA Requirements, And Study Evaluation

                                                            Explore Our Expertise

                                                            • Mass Spectrometry (LC-MS)

                                                            • Meso Scale Discovery Assay

                                                            • ELISA Assay

                                                            • Flow Cytometry

                                                            • qPCR Analysis, ddPCR Assay

                                                            • Western Blot, In Cell Western

                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Expertise

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • Flow Cytometry
                                                            • qPCR Analysis, ddPCR Assay
                                                            • Western Blot, In Cell Western

                                                            Services

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Multiplex Cytokine Assay
                                                            • Biomarker Assay
                                                            • Cell-Based Assay
                                                            • Bioanalytical Assay Validation

                                                            Solutions

                                                            Solutions

                                                            • Clinical CRO
                                                            • GLP Laboratory
                                                            • Preclinical CRO
                                                            • Method Development, Validation, And Transfer
                                                            • Analytical Testing

                                                            About Us

                                                            About Us

                                                            • Overview
                                                            • Leadership
                                                            • Facility and Equipment
                                                            • Quality and Compliance
                                                            • Therapeutic Areas
                                                            • Why Us?
                                                            • Values
                                                            • Process
                                                            • Partners
                                                            • Careers

                                                            Resources

                                                            Resources

                                                            • Learning Center
                                                            • Blog
                                                            • Case Study
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
                                                            NorthEast BioLab Logo Agile Bioanalytical Services CRO
                                                            sales@nebiolab.comFollow Up On Email
                                                            (203) 361 3780Follow Up On Phone

                                                            35 Worth Ave, Hamden, CT 06518

                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
                                                            • Food and Drug Administration (FDA | NorthEast BioLab
                                                            • clia
                                                            • United States Drug Enforcement Administration | NorthEast BioLab
                                                            • Department of Consumer Protection | NorthEast BioLab
                                                            • Privacy Policy
                                                            • Terms of Use
                                                            • Sitemap
                                                            All rights reserved.