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In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. Results: A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5-97.4%) and 100% (95% confidence interval 92.1-100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. Conclusions: The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods.

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BackgroundCeftolozane/tazobactam (C/T) efficacy and safety in ventilator-associated pneumonia (VAP) is being evaluated at a double dose by several trials. This dosing is based on a pharmacokinetic (PK) model that demonstrated that 3 g q8h achieved ≥90% probability of target attainment (50% ƒT > minimal inhibitory concentration [MIC]) in plasma and epithelial lining fluid against C/T-susceptible P. aeruginosa. The aim of this study was to evaluate the efficacy of different C/T doses in patients with lower respiratory infection (LRI) due to MDR- or XDR-P. aeruginosa considering the C/T MIC.MethodsThis was a multicenter retrospective study of 90 patients with LRI caused by resistant P. aeruginosa who received a standard or high dose (HDo) of C/T. Univariable and multivariable analyses were performed to identify independent predictors of 30-day mortality.ResultsThe median age (interquartile range) was 65 (51–74) years. Sixty-three (70%) patients had pneumonia, and 27 (30%) had tracheobronchitis. Thirty-three (36.7%) were ventilator-associated respiratory infections. The median C/T MIC (range) was 2 (0.5–4) mg/L. Fifty-four (60%) patients received HDo. Thirty-day mortality was 27.8% (25/90). Mortality was significantly lower in patients with P. aeruginosa strains with MIC ≤2 mg/L and receiving HDo compared with the groups with the same or higher MIC and dosage (16.2% vs 35.8%; P = .041). Multivariate analysis identified septic shock (P < .001), C/T MIC >2 mg/L (P = .045), and increasing Charlson Comorbidity Index (P = .019) as independent predictors of mortality.ConclusionsThe effectiveness of C/T in P. aeruginosa LRI was associated with an MIC ≤2 mg/L, and the lowest mortality was observed when HDo was administered for strains with C/T MIC ≤2 mg/L. HDo was not statistically associated with a better outcome.

21In the context of the Covid-19 pandemic, the development and validation of rapid and easy-to-22 perform diagnostic methods are of high priority. We compared the performance of four rapid 23 antigen detection tests for SARS-CoV-2 in respiratory samples. Immunochromatographic SARS-24CoV-2 assays from RapiGEN, Liming bio, Savant, and Bioeasy were evaluated using universal 25 transport medium containing naso-oropharyngeal swabs from suspected Covid-19 cases. The 26 diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR. A total of 111 27 samples were included; 80 were RT-PCR positive. Median patients' age was 40 years, 55% were 28 female, and 88% presented within the first week after symptom onset. The evaluation of the 29Liming bio assay was discontinued due to insufficient performance. The overall sensitivity 30 values of RapiGEN, Liming bio, and Bioeasy tests were 62.0% (CI95% 51.0-71.9), 16.7% 31 (CI95% 10.0-26.5), and 85.0% (CI95% 75.6-91.2), respectively, with specificities of 100%. 32Sensitivity was significantly higher in samples with high viral loads (RapiGEN, 84.9%; Bioeasy, 33 100%). The study highlighted the significant heterogeneity of test performance among evaluated 34 assays, which might have been influenced by the use of a non-validated sample material. The 35 high sensitivity of some tests demonstrated that rapid antigen detection has the potential to serve 36 as an alternative diagnostic method, especially in patients presenting with high viral loads in 37 early phases of infection. This is particularly important in situations with limited access to PCR or prolonged turnaround time. Further comparative evaluations are necessary to select 39 products with high performance among the growing market of diagnostic tests for SARS-CoV-2. 40 41

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