{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:30:54Z","timestamp":1790620254754,"version":"4.1.0"},"reference-count":85,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:00:00Z","timestamp":1781136000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"SD Biosensor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: Arboviruses including dengue virus (DENV), Zika virus (ZIKV), chikungunya virus (CHIKV), yellow fever virus (YFV), and West Nile virus (WNV) co-circulate across the Americas, generating overlapping febrile syndromes that challenge etiological diagnosis based solely on clinical criteria. Cartridge-based multiplex molecular platforms offer potential for decentralized testing in hyperendemic settings, yet independent real-world evaluations of their clinical and analytical performance remain limited. Methods: A retrospective two-phase analytical study was conducted. Phase 1 assessed clinical diagnostic accuracy for dengue using 163 de-identified serum samples classified using a composite reference standard consisting of Panbio NS1 ELISA reactivity (\u226511 Panbio units) combined with compatible clinical and epidemiological data, operationalized in accordance with the PAHO 2023 laboratory confirmation algorithm for dengue; RT-qPCR was not routinely available for all archived samples, and reported sensitivity should therefore be interpreted as a conservative lower-bound estimate; Phase 2 evaluated analytical sensitivity across all eight panel targets using characterized arboviral reference strains in serial dilution experiments, with reference RT-qPCR assays as the comparator; this phase was incorporated to characterize detection thresholds for targets not represented by clinical specimens. Results: In Phase 1, the M10 demonstrated sensitivity of 96.0% (96\/100), specificity of 100% (63\/63), overall accuracy of 97.5%, and near-perfect agreement with the reference standard (Cohen\u2019s \u03ba = 0.95). DENV-3 was the predominant serotype (74\/96; 77.1%), followed by DENV-1 (16.7%) and DENV-4 (6.3%); DENV-2 was not detected. In Phase 2, operational LoDs (defined as the lowest concentration yielding a detectable Ct in all triplicate reactions for the RT-qPCR, and from a single cartridge per dilution point for the STANDARD M10) were equivalent or superior to reference RT-qPCR for six targets (DENV-1, DENV-3, DENV-4, ZIKV, WNV, YFV; range 1\u20135 PFU\/mL), while DENV-2 and CHIKV showed 20-fold higher operational LoDs (20 PFU\/mL vs. 1 PFU\/mL for the reference RT-qPCR); formal LoD95 estimates were not determined. Conclusions: The STANDARD M10 Arbovirus Panel shows high clinical accuracy for dengue and adequate analytical sensitivity for most targets, supporting its use as a complementary decentralized molecular tool. Reduced sensitivity for DENV-2 and CHIKV and the absence of formal LoD95 estimates remain key limitations to be addressed in future validation studies.<\/jats:p>","DOI":"10.3390\/diagnostics16121799","type":"journal-article","created":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T05:50:58Z","timestamp":1781157058000},"page":"1799","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Analytical and Clinical Evaluation of the STANDARD M10 Arbovirus Panel for Dengue Detection, Serotyping, and Multiplex Arboviral Screening in the Americas"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-4637-2796","authenticated-orcid":false,"given":"Stephany","family":"Young Yusty","sequence":"first","affiliation":[{"name":"Departamento de Microbiolog\u00eda Humana, Facultad de Medicina, Universidad de Panam\u00e1, Panama City 0816-00588, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3596-063X","authenticated-orcid":false,"given":"Maria","family":"Chen-Germ\u00e1n","sequence":"additional","affiliation":[{"name":"Laboratorio Modular Especializado, Departamento de Virolog\u00eda y Biotecnolog\u00eda, Instituto Conmemorativo Gorgas para Estudios de la Salud, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5387-034X","authenticated-orcid":false,"given":"Dimelza","family":"Arauz","sequence":"additional","affiliation":[{"name":"Laboratorio Modular Especializado, Departamento de Virolog\u00eda y Biotecnolog\u00eda, Instituto Conmemorativo Gorgas para Estudios de la Salud, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Vega","sequence":"additional","affiliation":[{"name":"Laboratorio Modular Especializado, Departamento de Virolog\u00eda y Biotecnolog\u00eda, Instituto Conmemorativo Gorgas para Estudios de la Salud, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisseth","family":"Saenz","sequence":"additional","affiliation":[{"name":"Laboratorio Modular Especializado, Departamento de Virolog\u00eda y Biotecnolog\u00eda, Instituto Conmemorativo Gorgas para Estudios de la Salud, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2613-2047","authenticated-orcid":false,"given":"Mabel","family":"Mart\u00ednez-Montero","sequence":"additional","affiliation":[{"name":"Secci\u00f3n de Inmunovirolog\u00eda del LCRSP, Instituto Conmemorativo Gorgas para Estudios de la Salud, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Yanguez","sequence":"additional","affiliation":[{"name":"Regi\u00f3n Metropolitana de Salud, Ministerio de Salud de Panam\u00e1, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brechla","family":"Moreno","sequence":"additional","affiliation":[{"name":"Laboratorio Modular Especializado, Departamento de Virolog\u00eda y Biotecnolog\u00eda, Instituto Conmemorativo Gorgas para Estudios de la Salud, Panama City 0816-02593, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilberto A.","family":"Eskildsen","sequence":"additional","affiliation":[{"name":"Departamento de Microbiolog\u00eda Humana, Facultad de Medicina, Universidad de Panam\u00e1, Panama City 0816-00588, Panama"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"WHO (2026). 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