Validation and clinical application of dried blood spot assay for quantitative assessment of edoxaban in healthy adults

Bioanalysis ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 393-407
Author(s):  
Ling He ◽  
Roohi Gajee ◽  
Raj Mangaraj ◽  
Michael P Waldron ◽  
Karen S Brown
Keyword(s):  
Healthy Subjects ◽  
Quantitative Assessment ◽  
Dried Blood Spot ◽  
Plasma Samples ◽  
Open Label ◽  
Finger Prick ◽  
Incurred Sample Reanalysis ◽  
Alternative Methodology ◽  
Blood Spot ◽  
Sampling Approach

Aim: Dried blood spot (DBS) is a sampling approach that offers several advantages over plasma and whole blood (WB) sampling, but several factors, such as hematocrit and temperature, can adversely affect quantitation. Methodology & results: In an open-label, three-way crossover study in healthy subjects, we explored the correlation between DBS, WB and plasma samples, and between DBS samples from finger-prick and venipuncture blood for measuring edoxaban and its metabolite M-4 using LC–MS/MS. The methods were validated comprehensively. The incurred sample reanalysis experiments demonstrated quantitation reproducibility in all three matrices. Overall, there was a good correlation (near perfect concordance for edoxaban) among plasma, WB and DBS measurements. M-4 concentrations in DBS and WB were lower than in plasma. Conclusion: These results indicate using DBS may be used as an alternative methodology to measure edoxaban pharmacokinetics.

scholarly journals Development and validation of a LC-MS/MS method for ivermectin quantification in dried blood spots: application to a pharmacokinetic study inTrichuris trichiura-infected adults

2018 ◽  
Vol 10 (24) ◽  
pp. 2901-2909 ◽  
Author(s):  
Jessica D. Schulz ◽  
Anna Neodo ◽  
Jean T. Coulibaly ◽  
Jennifer Keiser
Keyword(s):  
Pharmacokinetic Study ◽  
Dried Blood Spots ◽  
Trichuris Trichiura ◽  
Dried Blood Spot ◽  
Plasma Samples ◽  
Blood Spots ◽  
Development And Validation ◽  
Blood Spot

Ivermectin was quantified in dried blood spot and plasma samples derived fromTrichuris trichiura-infected adults with a validated LC-MS/MS method.

GlaxoSmithKline’s experience of incurred sample reanalysis for dried blood spot samples

Bioanalysis ◽  
2011 ◽  
Vol 3 (9) ◽  
pp. 1025-1030 ◽  
Author(s):  
Matthew Barfield ◽  
Sheelan Ahmad ◽  
Maria Busz
Keyword(s):  
Dried Blood Spot ◽  
Incurred Sample Reanalysis ◽  
Blood Spot

scholarly journals Performance of Immunoglobulin G Serology on Finger Prick Capillary Dried Blood Spot Samples to Measure SARS-CoV-2 Humoral Immunogenicity

2021 ◽  
Author(s):  
Aidan M Nikiforuk ◽  
Brynn McMillan ◽  
Sofia R Bartlett ◽  
Ana Citlali Marquez ◽  
Tamara Pidduck ◽  
...  
Keyword(s):  
Immunoglobulin G ◽  
Predictive Value ◽  
Vaccine Coverage ◽  
Characteristic Curve ◽  
Dried Blood Spot ◽  
Serum Samples ◽  
Meso Scale Discovery ◽  
Cross Sectional ◽  
Finger Prick ◽  
Blood Spot

Abstract: Importance: Measuring humoral immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines and finding population-level correlates of protection against coronavirus disease (COVID-19) presents an immediate challenge to public health practitioners. Objective: To study the diagnostic accuracy and predictive value of finger prick capillary dried blood spot (DBS) samples tested using an anti-immunoglobulin G (IgG) serology assay to measure SARS-CoV-2 seropositivity and the humoral immunogenicity of COVID-19 vaccination. Design, Setting and Participants: This cross-sectional study enrolled participants (n= 644) who had paired DBS and serum samples collected by finger prick and venipuncture, respectively, in British Columbia, Canada between January 12th, 2020 and May 21st, 2021. Samples were tested by a multiplex electrochemiluminescence assay for SARS-CoV-2 anti-Spike (S), -Nucleocapsid (N) and -receptor binding domain (RBD) IgG reactivity using a Meso Scale Discovery (MSD) platform. Additionally, unpaired DBS samples (n= 6,706) that were collected in the province during the same time period were included for analysis of SARS-CoV-2 anti-N IgG reactivity. Exposure: Collection of a capillary DBS by finger prick alone or paired with serum by venipuncture. Outcome: Humoral immune response to SARS-CoV-2 measured by detection of anti-S, -N or -RBD IgG. Results: In comparison to a paired-serum reference, DBS samples possessed a sensitivity of 80% (95% CI: 61%-91%) and specificity of 97% (95% CI: 95%-98%). Receiver operator characteristic curve analysis (ROC) found that participant DBS samples tested for anti-SARS-CoV-2 IgG by MSD V-PLEX COVID-19 Coronavirus Panel 2 assay accurately classify SARS-CoV-2 seroconversion at an 88% percent rate, AUC= 88% (95% CI: 81%-96%). Modelling found that a DBS-based testing approach has a high positive predictive value (PPV) (98% [95% CI: 98%-99%]) in a theoretical population with seventy-five percent COVID-19 vaccine coverage. At lower vaccine coverages of fifteen and forty-five percent, the test's PPV decreased and the negative predictive value increased. Conclusion: We demonstrate that DBS samples, when tested using an electrochemiluminescence assay, provide a valid alternative to traditional venipuncture and should be considered to reliably detect SARS-CoV-2 seropositivity.

scholarly journals Pharmacokinetic Study and Incurred Sample Stability of Esomeprazole in Dried Blood Spot Sample Using High Performance Liquid Chromatography-Photodiode Array

2020 ◽  
Vol 20 (5) ◽  
pp. 979
Author(s):  
Yahdiana Harahap ◽  
Anja Tamabri ◽  
Vicha Vicha ◽  
Herman Suryadi ◽  
Sunarsih Sunarsih ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Pharmacokinetic Study ◽  
Healthy Subjects ◽  
High Performance ◽  
Dried Blood Spot ◽  
Sample Stability ◽  
Percent Difference ◽  
Photodiode Array ◽  
Blood Spot

In the past years, Esomeprazole (EMP) was analyzed in human plasma samples, which still has stability issues; thus, the new biosampling technique known as Dried Blood Spot (DBS) might solve the issue. This research aims to evaluate the incurred sample stability of esomeprazole in dried blood spot using high performance liquid chromatography-photodiode array with lansoprazole as an internal standard. The analytical separation was performed on a C-18 column (Waters, Sunfire™ 5 μm; 250 × 4.6 mm) at 40 °C. The mobile phase used was acetonitrile–phosphate buffer pH 7.6 (40:60% v/v) with a flow rate of 1.00 mL/min; and was detected at 300 nm. The analyte was extracted from dried blood spot by methanol. Incurred sample stability was evaluated from 6 healthy subjects on day 0, 7, 14, and 28, respectively. This method was linear in the range concentration of 70–1400 ng/mL with r > 0.98. Pharmacokinetic study shows that the average of AUC0–t of EMP in the DBS sample was 1765.41 ngh/mL. The highest percent difference value of esomeprazole’s incurred samples stability on day 7, 14, and 28 from 6 healthy subjects were 9.81%. This result fulfilled the acceptance criteria, which is the percent difference should not be greater than 20%, and 67% of total samples have to fulfill the criteria. The incurred sample stability result showed that esomeprazole was stable in the DBS sample at least until 28 days with the highest value of percent difference is 9.81%.

Novel methodology to perform incurred sample reanalysis on dried blood spot cards: Experimental data using darolutamide and filgotinib

2020 ◽  
Vol 34 (11) ◽  
Author(s):  
Vinay Kiran ◽  
Abhishek Dixit ◽  
Bhavesh Babulal Gabani ◽  
Nuggehally R. Srinivas ◽  
Ramesh Mullangi
Keyword(s):  
Experimental Data ◽  
Dried Blood Spot ◽  
Incurred Sample Reanalysis ◽  
Blood Spot

scholarly journals Use of dried blood spot samples for SARS-CoV-2 antibody detection using the Roche Elecsys ® high throughput immunoassay

2020 ◽  
Author(s):  
Ranya Mulchandani ◽  
Ben Brown ◽  
Tim Brooks ◽  
Amanda Semper ◽  
Nicholas Machin ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Dried Blood Spot ◽  
Antibody Detection ◽  
Sample Type ◽  
Index Test ◽  
Plasma Samples ◽  
Reference Test ◽  
Blood Samples ◽  
Sample Quality ◽  
Blood Spot

AbstractBackgroundDried blood spot samples (DBS) provide an alternative sample type to venous blood samples for antibody testing. DBS are used by NHS for diagnosing HCV and by PHE for large scale HIV and Hepatitis C serosurveillance; the applicability of DBS based approaches to SARS-CoV-2 antibody detection is uncertain.ObjectiveTo compare antibody detection in dried blood spot eluates using the Roche Elecsys ® immunoassay (index test) with antibody detection in paired plasma samples, using the same assay (reference test).SettingOne Police and one Fire & Rescue facility in England.Participants195 participants within a larger sample COVID-19 serodiagnostics study of keyworkers, EDSAB-HOME.Outcome MeasuresSensitivity and specificity of DBS (the index test) relative to plasma (the reference test), at an experimental cut-off; quality of DBS sample collected; estimates of relative sensitivity of DBS vs. plasma immunoassay in a larger population.Results18/195 (9.2%) participants tested positive using plasma samples. DBS sample quality varied markedly by phlebotomist, and low sample volume significantly reduced immunoassay signals. Using a cut-off of ten median absolute deviations above the immunoassay result with negative samples, sensitivity and specificity of DBS were 89.0% (95% CI 67.2, 96.9%) and 100.0% (95% CI 97.9, 100%) respectively compared with using plasma. The limit of detection for DBS is about 30 times higher than for plasma.ConclusionDBS use for SARS-CoV-2 serology, though feasible, is insensitive relative to immunoassays on plasma. Sample quality impacts on assay performance. Alternatives, including the collection of capillary blood samples, should be considered for screening programs.

scholarly journals PHARMACOKINETIC PROFILE OF METFORMIN HYDROCHLORIDE IN DRIED BLOOD SPOT OF HEALTHY SUBJECTS USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY–PHOTODIODE ARRAY

2018 ◽  
Vol 10 (1) ◽  
pp. 354
Author(s):  
Yahdiana Harahap ◽  
Citra Dara Malia ◽  
Sunarsih .
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Healthy Subjects ◽  
High Performance ◽  
Pharmacokinetic Profile ◽  
Dried Blood Spot ◽  
Metformin Hydrochloride ◽  
Linear Calibration ◽  
Photodiode Array ◽  
Blood Spot

Objective: This study aimed to analyze the metformin hydrochloride in dried blood spot (DBS) sample and evaluate a pharmacokinetic profile in sixhealthy subjects who administered 850-mg metformin hydrochloride in tablet using high-performance liquid chromatography–photodiode array(HPLC–PDA).Methods: Metformin analysis was performed on data of six healthy subjects who administered 850 mg of metformin hydrochloride as tablets. Bloodsamples were taken at 12-time points at intervals of up to 12 h, and data were analyzed using HPLC–PDA.Results: A linear calibration curve was obtained in the range of 25–5000 ng/mL, with r=0.9990. Pharmacokinetic profiles of metformin were obtainedusing DBS samples from six healthy participants, with a Cmax of 347.3–416.22 ng/mL. The average tmax and t1/2 were obtained at 3 and 2 h, respectively,and the area under the curve (AUC)0-t/AUC0-∞ ratio was >80% for all subjects.Conclusion: The DBS biosampling technique can be developed for application in pharmacokinetic study of metformin HCl.

Quantitative assessment of anthrax vaccine immunogenicity using the dried blood spot matrix

Biologicals ◽  
2013 ◽  
Vol 41 (2) ◽  
pp. 98-103 ◽  
Author(s):  
Jarad M. Schiffer ◽  
Panagiotis Maniatis ◽  
Ilana Garza ◽  
Evelene Steward-Clark ◽  
Lawrence T. Korman ◽  
...  
Keyword(s):  
Quantitative Assessment ◽  
Dried Blood Spot ◽  
Anthrax Vaccine ◽  
Vaccine Immunogenicity ◽  
Blood Spot
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