264
Views
0
CrossRef citations to date
0
Altmetric
Research Article

Decentralized Clinical Trial Design Using Blood Microsampling Technology for Serum Bioanalysis

ORCID Icon, , , , &
Pages 1287-1303 | Received 13 Jul 2023, Accepted 12 Sep 2023, Published online: 19 Oct 2023

References

  • Gul RB , AliPA. Clinical trials: the challenge of recruitment and retention of participants. J. Clin. Nurs.19(1–2), 227–233 (2010).
  • Milton S , McintoshJ, BoydL, KarnchanachariN, MacraeF, EmeryJD. Commentary: pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19. Trials22(1), 605–609 (2021).
  • Van Dorn A . COVID-19 and readjusting clinical trials. Lancet396(10250), 523–524 (2020).
  • Wan KX , PottsD, GonzalezP, SmithI, ShiH, KavetskaO. Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device. Bioanalysis14(20), 1305–1315 (2022).
  • Spooner N , AndersonKD, SipleJ, WickremsinheER, XuY, LeeM. Microsampling: considerations for its use in pharmaceutical drug discovery and development. Bioanalysis11(10), 1015–1038 (2019).
  • Maass KF , BarfieldMD, ItoMet al. Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: promise to reality. Clin. Transl. Sci.15(12), 2785–2795 (2022).
  • Goodson N , WicksP, MorganJ, HashemL, CallinanS, ReitesJ. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. NPJ Digit. Med.5(1), 58 (2022).
  • Lovett L . Better data, decentralized trials may help fix research's diversity problem. (2021). www.mobihealthnews.com/news/big-data-decentralized-trials-may-help-fix-researchs-diversity-problem
  • Xing J , LoureiroJ, PatelMT, MikhailovD, GusevAI. Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis. Bioanalysis12(13), 919–935 (2020).
  • Wickremsinhe E , FantanaA, BerthierEet al. Standard venipuncture vs a capillary blood collection device for the prospective determination of abnormal liver chemistry. J. Appl. Lab. Med.8(3), 535–550 (2023).
  • Gao X , ChenC, GengDet al. Volumetric absorptive microsampling (VAMS(R)) in therapeutic protein quantification by LC-MS/MS: investigation of anticoagulant impact on assay performance and recommendations for best practices in method development. J. Pharm. Biomed. Anal.196, 113895 (2021).
  • Ren T , RenJ, MatelliniDB, OuyangW. A comprehensive review of modern cold chain shipping solutions. Sustainability14(22), 14746 (2022).
  • Lippi G , SalvagnoGL, MontagnanaM, BroccoG, GuidiGC. Influence of hemolysis on routine clinical chemistry testing. Clin. Chem. Lab. Med.44(3), 311–316 (2006).
  • Wenk RE . Mechanism of interference by hemolysis in immunoassays and requirements for sample quality. Clin. Chem.44(12), 2554 (1998).
  • Qin X , ZhengC, LiY, LuX, MaoQ. Evaluation of the effect of hemolysis on quantitative chemiluminescent immunoassay results for 10 analytes. Clin. Lab.67(11), (2021).
  • Harboe M . A method for determination of hemoglobin in plasma by near-ultraviolet spectrophotometry. Scand. J. Clin. Lab. Invest.11, 66–70 (1959).
  • Cookson P , SutherlandJ, CardiganR. A simple spectrophotometric method for the quantification of residual haemoglobin in platelet concentrates. Vox Sang.87(4), 264–271 (2004).
  • MedlinePlus. Comprehensive metabolic panel. (2023). https://medlineplus.gov/ency/article/003468.htm
  • Kwo PY , CohenSM, LimJK. ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries. Am. J. Gastroenterol.112(1), 18–35 (2017).
  • Shrimanker I , BhattaraiS. Electrolytes. In: StatPearls.Treasure IslandFL, USA (2023).
  • Gold L , WalkerJJ, WilcoxSK, WilliamsS. Advances in human proteomics at high scale with the SomaScan proteomics platform. New Biotechnol.29(5), 543–549 (2012).
  • Lever J , KrzywinskiM, AltmanN. Principal component analysis. Nat. Methods14(7), 641–642 (2017).
  • Hodge RG , RidleyAJ. Regulating Rho GTPases and their regulators. Nat. Rev. Mol. Cell Biol.17(8), 496–510 (2016).
  • Justiz Vaillant AA , QurieA. Interleukin. In: StatPearls.Treasure Island, FL, USA (2023).
  • Isgrò MA , BottoniP, ScatenaR. Neuron-specific enolase as a biomarker: biochemical and clinical aspects. Adv. Exp. Med. Biol.867, 125–143 (2015).
  • Vizin T , KosJ. Gamma-enolase: a well-known tumour marker, with a less-known role in cancer. Radiol. Oncol.49(3), 217–226 (2015).
  • Liu CC , WangH, WangWDet al. ENO2 promotes cell proliferation, glycolysis, and glucocorticoid-resistance in acute lymphoblastic leukemia. Cell. Physiol. Biochem.46(4), 1525–1535 (2018).
  • Turchiano M , NguyenC, FiermanA, LifshitzM, ConvitA. Impact of blood sample collection and processing methods on glucose levels in community outreach studies. J. Environ. Public Health2013, 256151 (2013).
  • Williams KJ , LutmanJ, MccaugheyC, FischerSK. Assessment of low volume sampling technologies: utility in nonclinical and clinical studies. Bioanalysis13(9), 679–691 (2021).
  • Scuderi C , ParkerS, JacksMet al. Fingerprick microsampling methods can replace venepuncture for simultaneous therapeutic drug monitoring of tacrolimus, mycophenolic acid, and prednisolone concentrations in adult kidney transplant patients. Ther. Drug Monit.45(1), 69–78 (2023).
  • Baillargeon KR , MaceCR. Microsampling tools for collecting, processing, and storing blood at the point-of-care. Bioeng. Transl. Med.8(2), e10476 (2023).
  • Noble LD , DixonC, MoranAet al. Painless capillary blood collection: a rapid evaluation of the Onflow Device. Diagnostics (Basel)13(10), 1–14 (2023).
  • King ER , GarrettHE, AbernathyHet al. Comparison of capillary blood self-collection using the Tasso-SST device with venous phlebotomy for anti-SARS-CoV-2 antibody measurement. MedRxiv doi:10.1101/2023.03.13.23286935 (2023).
  • Silliman E , ChungEH, FitzpatrickEet al. Evaluation of at-home serum anti-Mullerian hormone testing: a head-to-head comparison study. Reprod. Biol. Endocrinol.20(1), 131 (2022).
  • Boyarsky BJ , WerbelWA, AveryRKet al. Antibody response to 2-dose SARS-CoV-2 mRNA vaccine series in solid organ transplant recipients. JAMA325(21), 2204–2206 (2021).
  • Pernet O , BalogS, KawaguchiESet al. Quantification of severe acute respiratory syndrome coronavirus 2 binding antibody levels to assess infection and vaccine-induced immunity using WHO standards. Microbiol. Spectr.11(1), e0370922 (2023).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.