{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T14:21:53Z","timestamp":1792074113973,"version":"4.4.0"},"reference-count":30,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2024,10,22]],"date-time":"2024-10-22T00:00:00Z","timestamp":1729555200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Objectives: Following the COVID-19 pandemic, global epidemiological trends demonstrate a return to pre-pandemic levels of respiratory syncytial virus (RSV) and influenza (Flu) A\/B viruses. For the appropriate clinical management of viral infections, reliable and timely diagnosis is crucial. The clinical presentation of these respiratory viral infections shows significant overlaps; thus, the syndromic diagnosis of these infections becomes challenging. The goal of this study was to compare the performance of three multiplex real-time PCR-based platforms for the detection of SARS-CoV-2, Flu A, Flu B, and RSV. Materials and Methods: A retrospective study was performed on 200 de-identified nasopharyngeal and oropharyngeal specimens. All samples were tested simultaneously on three PCR-based platforms for the detection of SARS-CoV-2, Flu A, Flu B, and RSV: HealthTrackRx\u2019s real-time PCR Open Array\u00ae respiratory panel, TrueMark\u2122 SARS-CoV-2, Flu A, Flu B, RSV Select Panel, and BioFire\u00ae RP2.1 Panel. The positive and negative predictive value of each test was evaluated at a 95% confidence interval. Results: Among the 200 tested samples, the TrueMark\u2122 and OpenArray\u00ae laboratory-developed tests (LDTs) showed a 100% concordance for the detection of SARS-CoV-2, Flu A, Flu B, and RSV. Overall agreement of 100% was observed for nasopharyngeal samples between the laboratory-developed tests and FDA-approved BioFire\u00ae RP2.1 Panel. Diagnostic results for these four respiratory viruses, in clinical samples, between the LDTs and the FDA-approved comparator demonstrated full concordance. Conclusions: Respiratory viral infections represent one of the major global healthcare burdens. Consequently, the accurate detection and surveillance of these viruses are critical, particularly when these viruses are known to co-circulate. The excellent performance and full concordance of the LDTs, with the BioFire\u00ae Respiratory RP2.1 panel, in detecting SARS-CoV-2, Flu A, Flu B, and RSV shows that these tests can be confidently implemented for the clinical testing of respiratory viral infections.<\/jats:p>","DOI":"10.3390\/diagnostics14212350","type":"journal-article","created":{"date-parts":[[2024,10,22]],"date-time":"2024-10-22T06:11:25Z","timestamp":1729577485000},"page":"2350","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Performance Assessment of a Multiplex Real-Time PCR Assay for Detection of Viruses Causing Respiratory Tract Infections"],"prefix":"10.3390","volume":"14","author":[{"given":"Pallavi","family":"Upadhyay","sequence":"first","affiliation":[{"name":"R&D Department, HealthTrackRx, Denton, TX 76207, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fahida","family":"Surur","sequence":"additional","affiliation":[{"name":"R&D Department, HealthTrackRx, Denton, TX 76207, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8798-4951","authenticated-orcid":false,"given":"Vijay","family":"Singh","sequence":"additional","affiliation":[{"name":"R&D Department, HealthTrackRx, Denton, TX 76207, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,10,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Bloom, D.E., and Cadarette, D. 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