{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T17:01:41Z","timestamp":1790010101598,"version":"4.0.1"},"reference-count":68,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>Functional nucleic acids can connect molecular recognition with chemical signal generation, but their diagnostic value depends on the performance of the complete sample-to-answer pathway. This critical narrative review examines representative studies published through 31 July 2026, with emphasis on recognition, amplification, material interfaces, sample preparation, readout and clinical interpretation under realistic conditions. Hybridization and ligation probes, aptamers, DNAzymes, DNA nanostructures and CRISPR-associated systems are compared by specificity, kinetics, leakage and matrix compatibility. Rolling circle amplification, hybridization chain reaction, catalytic hairpin assembly and enzymatic isothermal amplification are evaluated as reaction networks whose products must remain accessible to the selected interface. Functional materials are classified by their actual analytical role, including transduction, signal amplification, capture\/enrichment, spatial organization and reagent storage. Evidence is distinguished between mechanistic studies, spiked matrices, clinical specimens, manufactured-format reproducibility and demonstrated clinical utility. We further integrate sample-to-answer workflow, assay time, complexity, regulatory considerations and clinically relevant decision thresholds. Across the literature, reliable performance depends on selective recognition before high-gain reactions, compatibility between amplification products and interfaces, explicit controls for inhibition and leakage, and validation across independent lots and representative clinical populations. These principles define a path from analytical proof of concept to reproducible and clinically interpretable diagnostic testing.<\/jats:p>","DOI":"10.3390\/molecules31183358","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T16:06:51Z","timestamp":1790006811000},"page":"3358","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["From Molecular Recognition to Clinical Readout: Design Principles for Functional Nucleic Acid\u2013Material Biosensors in Medical Diagnostics"],"prefix":"10.3390","volume":"31","author":[{"given":"Qiming","family":"Chen","sequence":"first","affiliation":[{"name":"School of Life Sciences, Shanghai University, Shanghai 200444, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chengtian","family":"Xue","sequence":"additional","affiliation":[{"name":"School of Life Sciences, Shanghai University, Shanghai 200444, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanlong","family":"Hu","sequence":"additional","affiliation":[{"name":"School of Life Sciences, Shanghai University, Shanghai 200444, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiao","family":"Hong","sequence":"additional","affiliation":[{"name":"School of Life Sciences, Shanghai University, Shanghai 200444, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6442-9100","authenticated-orcid":false,"given":"Zhanmin","family":"Liu","sequence":"additional","affiliation":[{"name":"School of Life Sciences, Shanghai University, Shanghai 200444, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"119715","DOI":"10.1016\/j.cca.2024.119715","article-title":"Nucleic acid-based electrochemical biosensors","volume":"559","author":"Gunasekaran","year":"2024","journal-title":"Clin. Chim. Acta"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1146\/annurev-anchem-071124-103739","article-title":"Strategies for electrochemical point-of-care biosensors","volume":"18","author":"Deroco","year":"2025","journal-title":"Annu. Rev. Anal. Chem."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"7960","DOI":"10.1039\/D4CS00001C","article-title":"Nucleic acid-based wearable and implantable electrochemical sensors","volume":"53","author":"Yan","year":"2024","journal-title":"Chem. Soc. Rev."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"117328","DOI":"10.1016\/j.trac.2023.117328","article-title":"Next-generation CRISPR-based diagnostic tools for human diseases","volume":"168","author":"Wang","year":"2023","journal-title":"TrAC Trends Anal. Chem."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"114922","DOI":"10.1016\/j.bios.2022.114922","article-title":"Toehold-mediated biosensors: Types, mechanisms and biosensing strategies","volume":"220","author":"Li","year":"2023","journal-title":"Biosens. Bioelectron."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"118296","DOI":"10.1016\/j.trac.2025.118296","article-title":"Engineering CRISPR\/Cas12-based biosensors: Recent advances and future perspectives","volume":"191","author":"Yin","year":"2025","journal-title":"TrAC Trends Anal. Chem."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Zhou, L., Wei, K., Liu, Q., Wu, G., and Wang, K. (2026). Signal transduction and engineering strategies of CRISPR-Cas biosensors: A review. Anal. Chim. Acta, 346016.","DOI":"10.1016\/j.aca.2026.346016"},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Hu, K., Yin, W., Bai, Y., Zhang, J., Yin, J., Zhu, Q., and Mu, Y. (2024). CRISPR-based biosensors for medical diagnosis: Readout from detector-dependence detection toward naked-eye detection. Biosensors, 14.","DOI":"10.3390\/bios14080367"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1126\/science.2200121","article-title":"Systematic evolution of ligands by exponential enrichment: RNA ligands to bacteriophage T4 DNA polymerase","volume":"249","author":"Tuerk","year":"1990","journal-title":"Science"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"e16852","DOI":"10.1002\/advs.202516852","article-title":"Aptamer engineering: Strategies for discovering functional nucleic acids for next-generation diagnostics and biosensing","volume":"13","author":"Nguyen","year":"2026","journal-title":"Adv. Sci."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1016\/1074-5521(94)90014-0","article-title":"A DNA enzyme that cleaves RNA","volume":"1","author":"Breaker","year":"1994","journal-title":"Chem. Biol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"e202400085","DOI":"10.1002\/cbic.202400085","article-title":"In-vitro clinical diagnostics using RNA-cleaving DNAzymes","volume":"25","author":"Ali","year":"2024","journal-title":"ChemBioChem"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"4771","DOI":"10.1021\/ja028962o","article-title":"Structure-switching signaling aptamers","volume":"125","author":"Nutiu","year":"2003","journal-title":"J. Am. Chem. Soc."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"115788","DOI":"10.1016\/j.ab.2025.115788","article-title":"Exploring the diagnostic landscape: Portable aptasensors in point-of-care testing","volume":"700","author":"Mohan","year":"2025","journal-title":"Anal. Biochem."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"309","DOI":"10.26599\/NBE.2024.9290071","article-title":"Recent progress in electrochemical biosensors based on DNA-functionalized nanomaterials","volume":"16","author":"Yu","year":"2024","journal-title":"Nano Biomed. Eng."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"e2401360","DOI":"10.1002\/smtd.202401360","article-title":"Advancements in engineering tetrahedral framework nucleic acids for biomedical innovations","volume":"9","author":"Fan","year":"2025","journal-title":"Small Methods"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"2124","DOI":"10.1021\/ac4037262","article-title":"Hybridization chain reaction amplification of microRNA detection with a tetrahedral DNA nanostructure-based electrochemical biosensor","volume":"86","author":"Ge","year":"2014","journal-title":"Anal. Chem."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1148","DOI":"10.1039\/D4AY01803F","article-title":"The role of DNA nanotechnology in medical sensing","volume":"17","author":"Lien","year":"2025","journal-title":"Anal. Methods"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"438","DOI":"10.1126\/science.aam9321","article-title":"Nucleic acid detection with CRISPR-Cas13a\/C2c2","volume":"356","author":"Gootenberg","year":"2017","journal-title":"Science"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"436","DOI":"10.1126\/science.aar6245","article-title":"CRISPR-Cas12a target binding unleashes indiscriminate single-stranded DNase activity","volume":"360","author":"Chen","year":"2018","journal-title":"Science"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"117786","DOI":"10.1016\/j.bios.2025.117786","article-title":"CRISPR-based one-pot detection: A game-changer in nucleic acid analysis","volume":"288","author":"Li","year":"2025","journal-title":"Biosens. Bioelectron."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"778","DOI":"10.1021\/acsabm.3c01190","article-title":"DNA and nanomaterials: A functional combination for DNA sensing","volume":"7","author":"Quazi","year":"2024","journal-title":"ACS Appl. Bio Mater."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1038\/nnano.2007.260","article-title":"Intrinsic peroxidase-like activity of ferromagnetic nanoparticles","volume":"2","author":"Gao","year":"2007","journal-title":"Nat. Nanotechnol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"502","DOI":"10.1080\/10408347.2023.2298328","article-title":"Aptamer-magnetic nanoparticle complexes for powerful biosensing: A comprehensive review","volume":"55","author":"Altalbawy","year":"2025","journal-title":"Crit. Rev. Anal. Chem."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Theyagarajan, K., and Kim, Y.J. (2024). Metal organic frameworks based wearable and point-of-care electrochemical sensors for healthcare monitoring. Biosensors, 14.","DOI":"10.3390\/bios14100492"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"2082","DOI":"10.1039\/C8AY02798F","article-title":"Amplified visual detection of microRNA-378 through a T4 DNA ligase-mediated circular template specific to target and target-triggering rolling circle amplification","volume":"11","author":"Liu","year":"2019","journal-title":"Anal. Methods"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"134582","DOI":"10.1016\/j.snb.2023.134582","article-title":"A visual detection assay for Helicobacter pylori in saliva based on recombinase-aided amplification and peptide nucleic acid-assisted split DNAzyme probes","volume":"396","author":"Wang","year":"2023","journal-title":"Sens. Actuators B Chem."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1038\/s44328-025-00066-7","article-title":"General approach to achieving electrochemical aptamer-based sensor sensitivity of buffer in blood plasma","volume":"3","author":"Demek","year":"2026","journal-title":"npj Biosens."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"7843","DOI":"10.1021\/acs.analchem.1c00289","article-title":"Temperature-alternated electrochemical aptamer-based biosensor for calibration-free and sensitive molecular measurements in an unprocessed actual sample","volume":"93","author":"Chen","year":"2021","journal-title":"Anal. Chem."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"128646","DOI":"10.1016\/j.snb.2020.128646","article-title":"A turn-off colorimetric DNAzyme-aptasensor for ultra-high sensitive detection of viable Cronobacter sakazakii","volume":"322","author":"Liu","year":"2020","journal-title":"Sens. Actuators B Chem."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"136751","DOI":"10.1016\/j.snb.2024.136751","article-title":"Activated single nucleotide mismatch determination through toehold-embedded hairpin-mediated strand displacement reaction alongside CRISPR-Cas12a for detection of TP53 point mutation","volume":"423","author":"Marpaung","year":"2025","journal-title":"Sens. Actuators B Chem."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"10805","DOI":"10.1039\/D4CC03774J","article-title":"Recent advances in DNAzymes for bioimaging, biosensing and cancer therapy","volume":"60","author":"Sun","year":"2024","journal-title":"Chem. Commun."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"116122","DOI":"10.1016\/j.bios.2024.116122","article-title":"DNAzyme-based ultrasensitive immunoassay: Recent advances and emerging trends","volume":"251","author":"Wang","year":"2024","journal-title":"Biosens. Bioelectron."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1016\/j.mimet.2018.01.014","article-title":"Visual diagnostic of Helicobacter pylori based on a cascade amplification of PCR and G-quadruplex DNAzyme as a color label","volume":"146","author":"Liu","year":"2018","journal-title":"J. Microbiol. Methods"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"4477","DOI":"10.1039\/D0AN00270D","article-title":"A signal cascade amplification strategy based on RT-PCR triggering of a G-quadruplex DNAzyme for a novel electrochemical detection of viable Cronobacter sakazakii","volume":"145","author":"Yuan","year":"2020","journal-title":"Analyst"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/j.ab.2018.05.015","article-title":"Development of DNAzyme-based PCR signal cascade amplification for visual detection of Listeria monocytogenes in food","volume":"553","author":"Liu","year":"2018","journal-title":"Anal. Biochem."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"4795","DOI":"10.1039\/D6AY00648E","article-title":"A pathogen-activated DNAzyme triggers hybridization chain reaction for ultra-sensitive salivary detection of Helicobacter pylori","volume":"18","author":"Chen","year":"2026","journal-title":"Anal. Methods"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"125225","DOI":"10.1016\/j.talanta.2023.125225","article-title":"A CRISPR\/Cas12a-SERS platform for amplification-free detection of African swine fever virus genes","volume":"267","author":"Wang","year":"2024","journal-title":"Talanta"},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"8063","DOI":"10.1021\/acs.analchem.3c01033","article-title":"Fluorescence and colorimetric analysis of African swine fever virus based on the RPA-assisted CRISPR\/Cas12a strategy","volume":"95","author":"Mao","year":"2023","journal-title":"Anal. Chem."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"112068","DOI":"10.1016\/j.bios.2020.112068","article-title":"High-throughput and all-solution phase African swine fever virus detection using CRISPR-Cas12a and a fluorescence-based point-of-care system","volume":"154","author":"He","year":"2020","journal-title":"Biosens. Bioelectron."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"113701","DOI":"10.1016\/j.bios.2021.113701","article-title":"Exploiting orthogonal CRISPR-Cas12a\/Cas13a trans-cleavage for dual-gene virus detection using a handheld device","volume":"196","author":"Tian","year":"2022","journal-title":"Biosens. Bioelectron."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"115235","DOI":"10.1016\/j.ab.2023.115235","article-title":"Visual isothermal amplification detection of ASFV based on trimeric G-quadruplex cis-cleavage activity of Cas12a","volume":"676","author":"Chen","year":"2023","journal-title":"Anal. Biochem."},{"key":"ref_43","doi-asserted-by":"crossref","first-page":"6330","DOI":"10.1002\/anie.200705982","article-title":"Rolling circle amplification: Applications in nanotechnology and biodetection with functional nucleic acids","volume":"47","author":"Zhao","year":"2008","journal-title":"Angew. Chem. Int. Ed."},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"e01156","DOI":"10.1002\/smtd.202501156","article-title":"Rolling circle amplification boosts ultrasensitive liquid biopsy","volume":"9","author":"You","year":"2025","journal-title":"Small Methods"},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1016\/j.aca.2019.08.052","article-title":"A label-free fluorescent enhancement nanosensor for ultrasensitive and highly selective detection of miRNA-378 through signal synergy amplification","volume":"1087","author":"Liu","year":"2019","journal-title":"Anal. Chim. Acta"},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"802","DOI":"10.1038\/s41467-021-21121-7","article-title":"Rapid electrochemical detection of coronavirus SARS-CoV-2","volume":"12","author":"Chaibun","year":"2021","journal-title":"Nat. Commun."},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"15275","DOI":"10.1073\/pnas.0407024101","article-title":"Triggered amplification by hybridization chain reaction","volume":"101","author":"Dirks","year":"2004","journal-title":"Proc. Natl. Acad. Sci. USA"},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"318","DOI":"10.1038\/nature06451","article-title":"Programming biomolecular self-assembly pathways","volume":"451","author":"Yin","year":"2008","journal-title":"Nature"},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"e2207117","DOI":"10.1002\/smll.202207117","article-title":"Rapid visible detection of African swine fever virus using hybridization chain reaction-sensitized magnetic nanoclusters and affinity chromatography","volume":"19","author":"Lee","year":"2023","journal-title":"Small"},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"E63","DOI":"10.1093\/nar\/28.12.e63","article-title":"Loop-mediated isothermal amplification of DNA","volume":"28","author":"Notomi","year":"2000","journal-title":"Nucleic Acids Res."},{"key":"ref_51","doi-asserted-by":"crossref","unstructured":"Yang, N., Zhang, H., Han, X., Liu, Z., and Lu, Y. (2024). Advancements and applications of loop-mediated isothermal amplification technology: A comprehensive overview. Front. Microbiol., 15.","DOI":"10.3389\/fmicb.2024.1406632"},{"key":"ref_52","doi-asserted-by":"crossref","unstructured":"Piepenburg, O., Williams, C.H., Stemple, D.L., and Armes, N.A. (2006). DNA detection using recombination proteins. PLoS Biol., 4.","DOI":"10.1371\/journal.pbio.0040204"},{"key":"ref_53","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1007\/s44211-022-00251-y","article-title":"A visual denaturation bubble-mediated strand exchange amplification and RGB visual analysis-based assay for quantitative detection of Helicobacter pylori in saliva","volume":"39","author":"Wang","year":"2023","journal-title":"Anal. Sci."},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"31713","DOI":"10.1021\/acsnano.4c11857","article-title":"DNA nanomaterial-based electrochemical biosensors for clinical diagnosis","volume":"18","author":"Chu","year":"2024","journal-title":"ACS Nano"},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"1199","DOI":"10.1021\/acssensors.0c02455","article-title":"Interrogation of electrochemical aptamer-based sensors via peak-to-peak separation in cyclic voltammetry improves the temporal stability and batch-to-batch variability in biological fluids","volume":"6","author":"Pellitero","year":"2021","journal-title":"ACS Sens."},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"1586","DOI":"10.1021\/acsabm.3c00001","article-title":"Employing a redox reporter-modified self-assembly monolayer in electrochemical aptamer-based sensors to enable calibration-free measurements","volume":"6","author":"Zhu","year":"2023","journal-title":"ACS Appl. Bio Mater."},{"key":"ref_57","doi-asserted-by":"crossref","first-page":"6958","DOI":"10.1021\/acs.analchem.3c05920","article-title":"Single voltammetric sweep calibration-free interrogation of electrochemical aptamer-based sensors employing continuous square wave voltammetry","volume":"96","author":"Abeykoon","year":"2024","journal-title":"Anal. Chem."},{"key":"ref_58","doi-asserted-by":"crossref","first-page":"504","DOI":"10.1039\/D3SD00340J","article-title":"Paper-based point-of-care diagnostics for cancer biomarkers","volume":"3","author":"Bhardwaj","year":"2024","journal-title":"Sens. Diagn."},{"key":"ref_59","doi-asserted-by":"crossref","first-page":"124317","DOI":"10.1016\/j.talanta.2023.124317","article-title":"A time-resolved fluorescent microsphere-lateral flow immunoassay strip assay with image visual analysis for quantitative detection of Helicobacter pylori in saliva","volume":"256","author":"Wang","year":"2023","journal-title":"Talanta"},{"key":"ref_60","doi-asserted-by":"crossref","first-page":"115840","DOI":"10.1016\/j.ab.2025.115840","article-title":"Colorimetric and fluorescent dual-modality assay for cell-free mitochondrial DNA copy number in saliva","volume":"702","author":"Wang","year":"2025","journal-title":"Anal. Biochem."},{"key":"ref_61","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1093\/infdis\/jiaa641","article-title":"Rapid, sensitive, and specific severe acute respiratory syndrome coronavirus 2 detection: A multicenter comparison between standard quantitative reverse-transcriptase polymerase chain reaction and CRISPR-based DETECTR","volume":"223","author":"Brandsma","year":"2021","journal-title":"J. Infect. Dis."},{"key":"ref_62","doi-asserted-by":"crossref","unstructured":"Abugattas-N\u00fa\u00f1ez del Prado, J., Quintana Reyes, A., Leon, J., Blume La Torre, J., Guti\u00e9rrez Loli, R., Pinz\u00f3n Olejua, A., Chamorro Chirinos, E.R., Loza Mauricio, F.A., Magui\u00f1a, J.L., and Rodriguez-Aliaga, P. (2024). Clinical validation of RCSMS: A rapid and sensitive CRISPR-Cas12a test for the molecular detection of SARS-CoV-2 from saliva. PLoS ONE, 19.","DOI":"10.1371\/journal.pone.0290466"},{"key":"ref_63","doi-asserted-by":"crossref","first-page":"11686","DOI":"10.1021\/ja203693b","article-title":"A ligation-triggered DNAzyme cascade for amplified fluorescence detection of biological small molecules with zero-background signal","volume":"133","author":"Lu","year":"2011","journal-title":"J. Am. Chem. Soc."},{"key":"ref_64","doi-asserted-by":"crossref","first-page":"8354","DOI":"10.1021\/acs.analchem.4c06815","article-title":"Early-stage lung cancer diagnosis by a point-of-care electrochemical aptamer-based sensor of NAP2 in human serum","volume":"97","author":"He","year":"2025","journal-title":"Anal. Chem."},{"key":"ref_65","unstructured":"World Health Organization (2024). SARS-CoV-2 Nucleic Acid Tests: Protocol for Performance Evaluation of In Vitro Diagnostics for WHO Prequalification Assessment, WHO."},{"key":"ref_66","unstructured":"U.S. Food and Drug Administration (2024). Overview of IVD Regulation."},{"key":"ref_67","doi-asserted-by":"crossref","first-page":"826","DOI":"10.1148\/radiol.2015151516","article-title":"STARD 2015: An updated list of essential items for reporting diagnostic accuracy studies","volume":"277","author":"Bossuyt","year":"2015","journal-title":"Radiology"},{"key":"ref_68","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1021\/acssensors.3c01868","article-title":"Analytical validation of aptamer-based serum vancomycin monitoring relative to automated immunoassays","volume":"9","author":"Liu","year":"2024","journal-title":"ACS Sens."}],"container-title":["Molecules"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1420-3049\/31\/18\/3358\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T16:08:22Z","timestamp":1790006902000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1420-3049\/31\/18\/3358"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,21]]},"references-count":68,"journal-issue":{"issue":"18","published-online":{"date-parts":[[2026,9]]}},"alternative-id":["molecules31183358"],"URL":"https:\/\/doi.org\/10.3390\/molecules31183358","relation":{},"ISSN":["1420-3049"],"issn-type":[{"value":"1420-3049","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,21]]}}}