Rapid diagnosis of SARS-CoV-2 pneumonia on lower respiratory tract specimens

Abstract Background The ongoing SARS-CoV-2 pandemic requires the availability of accurate and rapid diagnostic tests, especially in such clinical settings as emergency intensive care units. objective this study was to evaluate performance Vivalytic PCR kit lower respiratory tract (LRT) specimens. Methods Consecutive LRT specimens (bronchoalveolar lavage bronchoaspirates) were collected from Intensive Care Units San Martino Hospital (Genoa, Italy) between November 2020 January 2021. All samples underwent RT-PCR testing by means Allplex™ assay (Seegene Inc., South Korea). On basis results, categorized negative, positive with high viral load [cycle threshold (Ct) ? 30] low (Ct 31–35). A 1:1:1 ratio used achieve a sample size 75. subsequently tested (Bosch Healthcare Solutions GmbH, Germany). assessed against through calculation accuracy, Cohen’s ? , sensitivity, specificity expected (PPV) negative (NPV) predictive values. Results overall accuracy 97.3% (95% CI: 90.9–99.3%), an excellent 0.94 0.72–1). Sensitivity 96% 86.5–98.9%) 100% 86.7–100%), respectively. In loads, sensitivity (Table 1). distributions E gene Ct values similar (Wilcoxon’s test: p = 0.070), medians 35 (IQR: 25–36) 25–35) on RT-PCR, respectively (Fig. NPV PPV 92.6% 100%, Table 1 Demographic characteristics data type cases (N 75) Male, N (%) 56 (74.6%) Age (yr), Median (IQR) 65 (31–81) BAS, 43 (57.3%) Negative 30.2% Positive—High [Ct 27.9% Positive—Low 31–35] 41.9% BAL, 32 (42.7%) 37.5% 40.6% 21.9% Data expressed proportions for categorical variables. Specimens into BAS bronchoaspirates, BAL bronchoalveolar lavage, cycle Conclusions can be effectively following liquefaction. It is feasible highly molecular procedure, loads. This yields results about 40 min, may therefore accelerate decision-making urgent/emergency situations.