Rapid antigen tests, DFA, R-Mix culture and the xTAG RVP test all detected the novel H1N1 strain, but with highly varied sensitivity. The RVP test provided the best diagnostic option as RVP demonstrated superior sensitivity for the detection of all influenza strains, including the novel H1N1, provided accurate influenza A subtyping and identified a significant number of additional respiratory pathogens.

17Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the 18 globe. As part of the worldwide response, many molecular diagnostic platforms have been granted 19Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 20 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms 21 (Cepheid Xpert® Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW™ COVID-19 [ID NOW], GenMark 22 ePlex® SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow 23 for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found 24 that the Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/mL), followed by 25 the ePlex (100% detection at 1,000 copies/mL), and the ID NOW (20,000 copies/mL). The Xpert Xpress 26 also had highest positive percent agreement (PPA) when compared to our reference standard (98.3%) 27 followed by the ePlex (91.4%) and ID now (87.7%). All three assays showed 100% negative percent 28 agreement (NPA). In the workflow analysis, the ID NOW produced the most rapid time to result per 29 specimen (~17 minutes) as compared to the Xpert Xpress (~46 minutes) and the ePlex (~1.5 hours), but 30 what the ID NOW gained in rapid results, it lost in analytical and clinical performance. The ePlex had the 31 longest time to results and showed a slight improvement in PPA over the ID NOW. Information about 32 the clinical and analytical performance of these assays, as well as workflow, will be critical in making 33 informed and timely decisions on testing platform. 34 35

limit 250 words): 17The novel human coronavirus SARS-CoV-2 was first discovered in the city of Wuhan, Hubei 18 province, China, causing an outbreak of pneumonia in January 2020. As of April 10, 2020, the virus has 19 rapidly disseminated to over 200 countries and territories, causing more than 1.6 million confirmed cases 20 of COVID-19 and 97,000 deaths worldwide. The clinical presentation of COVID-19 is fairly non-specific, 21 and symptoms overlap with other seasonal respiratory infections concurrently circulating in the 22 population. Further, it is estimated that up to 80% of infected individuals experience mild symptoms or 23 are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically. To support infection 24 control measures, there is an urgent need for rapid and accurate molecular diagnostics to identify COVID-25 19 positive patients. In the present study, we have evaluated the analytical sensitivity and clinical 26 performance of four SARS-CoV-2 molecular diagnostic assays granted Emergency Use Authorization by 27 the FDA using nasopharyngeal swabs from symptomatic patients. This information is crucial for both 28 laboratories and clinical teams, as decisions on which testing platform to implement are made. 29 30

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g Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF) is gaining momentum as a tool for bacterial identification in the clinical microbiology laboratory. Compared with conventional methods, this technology can more readily and conveniently identify a wide range of organisms. Here, we report the findings from a multicenter study to evaluate the Vitek MS v2.0 system (bioMérieux, Inc.) for the identification of aerobic Gram-positive bacteria. A total of 1,146 unique isolates, representing 13 genera and 42 species, were analyzed, and results were compared to those obtained by nucleic acid sequence-based identification as the reference method. For 1,063 of 1,146 isolates (92.8%), the Vitek MS provided a single identification that was accurate to the species level. For an additional 31 isolates (2.7%), multiple possible identifications were provided, all correct at the genus level. Mixed-genus or single-choice incorrect identifications were provided for 18 isolates (1.6%). Although no identification was obtained for 33 isolates (2.9%), there was no specific bacterial species for which the Vitek MS consistently failed to provide identification. In a subset of 463 isolates representing commonly encountered important pathogens, 95% were accurately identified to the species level and there were no misidentifications. Also, in all but one instance, the Vitek MS correctly differentiated Streptococcus pneumoniae from other viridans group streptococci. The findings demonstrate that the Vitek MS system is highly accurate for the identification of Gram-positive aerobic bacteria in the clinical laboratory setting.