{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T14:57:52Z","timestamp":1787237872773,"version":"build-2736575974"},"reference-count":48,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AP Biotech"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Dengue is a mosquito-transmitted viral disease caused by the positive-sense RNA dengue virus (DENV), which comprises four antigenically distinct serotypes (1\u20134). Although DENV circulates predominantly in tropical and subtropical regions, its global incidence continues to increase. As most patients present viremia at the onset of clinical manifestations, real-time RT-PCR has become a widely adopted method for early dengue detection. The AP Biotech Discovery\u00ae Dengue Virus RT-PCR Detection Kit enables qualitative detection of DENV RNA (serotypes 1\u20134) by real-time RT-PCR in serum or plasma samples. The assay was recently cleared by ANMAT (National Administration of Drugs, Food and Medical Technology) as an in vitro diagnostic (IVD) assay. The Limit of Detection (LoD) was calculated for all 4 serotypes. Clinical validation was conducted among 296 serum and 221 plasma samples previously characterized as DENV-positive and -negative specimens. Among the positive samples, 56 had serotype characterization, including 25 DENV-1 and 31 DENV-2 samples. The resulting clinical sensitivity and specificity were 97.8%, 100.0% and 100.0%, 99.1% respectively. Additional validation studies demonstrated high reproducibility across three independent laboratories, absence of cross-reactivity with other febrile pathogens, and no interference from endogenous and exogenous substances at clinical levels. Collectively, these findings support the AP Biotech Discovery\u00ae Dengue Virus RT-PCR Detection Kit (AP Biotech, Lomas de Zamora, Argentina) as a sensitive, specific, and highly reproducible device for early dengue diagnosis and surveillance.<\/jats:p>","DOI":"10.3390\/v18080914","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T09:48:31Z","timestamp":1787219311000},"page":"914","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical and Analytical Performance of the AP Biotech Discovery\u00ae Dengue Virus RT-PCR Detection Kit"],"prefix":"10.3390","volume":"18","author":[{"given":"Valentina","family":"Hjelt","sequence":"first","affiliation":[{"name":"AP Biotech, Lomas de Zamora B1832FYA, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4533-0113","authenticated-orcid":false,"given":"Agustina","family":"Dronseck","sequence":"additional","affiliation":[{"name":"AP Biotech, Lomas de Zamora B1832FYA, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aldana Magal\u00ed","family":"Schey","sequence":"additional","affiliation":[{"name":"AP Biotech, Lomas de Zamora B1832FYA, Buenos Aires, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda Bel\u00e9n","family":"Mart\u00ed","sequence":"additional","affiliation":[{"name":"Laboratorio Mixto de Investigaci\u00f3n Traslacional en Salud, Centro de Tecnolog\u00eda en Salud P\u00fablica (CTSP), Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario, Rosario S2002LRK, Santa Fe, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3482-2212","authenticated-orcid":false,"given":"Luciano","family":"Civerchia","sequence":"additional","affiliation":[{"name":"Laboratorio Mixto de Investigaci\u00f3n Traslacional en Salud, Centro de Tecnolog\u00eda en Salud P\u00fablica (CTSP), Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario, Rosario S2002LRK, Santa Fe, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Laura","family":"Cavatorta","sequence":"additional","affiliation":[{"name":"Laboratorio Mixto de Investigaci\u00f3n Traslacional en Salud, Centro de Tecnolog\u00eda en Salud P\u00fablica (CTSP), Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario, Rosario S2002LRK, Santa Fe, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eduardo","family":"Codino","sequence":"additional","affiliation":[{"name":"Laboratorio Mixto de Investigaci\u00f3n Traslacional en Salud, Centro de Tecnolog\u00eda en Salud P\u00fablica (CTSP), Facultad de Ciencias Bioqu\u00edmicas y Farmac\u00e9uticas, Universidad Nacional de Rosario, Rosario S2002LRK, Santa Fe, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Nader","sequence":"additional","affiliation":[{"name":"Laboratorio Central, Sanatorio Allende, C\u00f3rdoba X5000BFB, C\u00f3rdoba, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalia Andrea","family":"Garro","sequence":"additional","affiliation":[{"name":"Laboratorio Central, Sanatorio Allende, C\u00f3rdoba X5000BFB, C\u00f3rdoba, Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico Manuel","family":"Aranda","sequence":"additional","affiliation":[{"name":"Unidad de Virolog\u00eda, Divisi\u00f3n An\u00e1lisis Cl\u00ednicos, Hospital de Infecciosas F. 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