The analytical performance of the new Aspergillus Galactomannan Ag VirCLIA^® mono-test (Vircell S.L.) was compared to the Platelia™ Aspergillus Ag ELISA assay (Bio-Rad). Prospective serum and bronchoalveolar lavage (BAL) samples from patients at risk of invasive aspergillosis (IA) were tested using both the Aspergillus Galactomannan Ag VirCLIA^® mono-test and the Platelia™ Aspergillus Ag ELISA assay. Concordance, sensitivity, specificity, and positive and negative predictive values were calculated using the manufacturer-recommended cutoff levels. Receiver operating characteristic (ROC) analysis and the Youden index were performed to determine the optimal cutoff. A total of 187 serum samples and 73 BAL samples were analyzed with both assays. The concordance between the Aspergillus Galactomannan Ag VirCLIA^® mono-test and the Platelia™ Aspergillus Ag ELISA assay was 87.8%, with a Cohen’s kappa of 0.75. The sensitivity and specificity of the Aspergillus Galactomannan Ag VirCLIA^® mono-test were 78.6% and 96.2%, respectively, with positive and negative predictive values of 94.8% and 83.3%. The ROC curve for the Aspergillus Galactomannan Ag VirCLIA^® mono-test demonstrated an area under the curve (AUC) of 0.87, and the Youden index at the manufacturer’s established cutoff was 0.73. This new Aspergillus Galactomannan Ag VirCLIA^® mono-test exhibited adequate analytical and clinical performance, showing good correlation with the Platelia™ Aspergillus Ag ELISA assay. The single-sample, semi-automated test is user-friendly, allowing small laboratories to perform the test on demand without the need for batch evaluations, providing a useful solution for timely diagnostic support for clinicians.

The role and durability of the immunogenicity of the BNT162b2 mRNA vaccine against severe acute respiratory virus 2 (SARS-CoV-2), in cancer patients one year after receiving the third dose have to be elucidated. We have prospectively evaluated the long-term immunogenicity of the third dose of the SARS-CoV-2 BNT162b2 mRNA vaccine in 55 patients undergoing active treatment. Neutralizing antibody (NT Ab) titers against Omicron variants and total anti-trimeric S IgG levels were measured one year after the third dose. Heparinized whole-blood samples were used for the assessment of the SARS-CoV-2 interferon-γ release assay (IGRA). Thirty-seven patients (67.3%) showed positive total anti-trimeric S IgG one year after the third dose. Looking at the T-cell response against the spike protein, the frequency of responder patients did not decrease significantly between six and twelve months after the third dose. Finally, less than 20% of cancer patients showed an undetectable NT Ab titer against BA.1 and BA.5 variants of concern (VOCs). Underlying therapies seem to not affect the magnitude or frequency of the immune response. Our work underlines the persistence of humoral and cellular immune responses against BNT162b2 in a cohort of cancer patients one year after receiving the third dose, regardless of the type of underlying therapy.

Coronavirus disease (COVID-19) is a systemic disease which can cause multiple organ failure and death primarly due to vascular endothelium injury. Severe acute respiratory distress syndrome (ARDS) is the main cause of death: its management and treatment should be tailored to the individual COVID-19 patient’s phenotype. Early diagnosis of COVID-19 is paramount for disease treatment and infection control. Naso-pharyngeal (NP) swab is commonly used as screening and diagnostic tool for COVID-19, but in some cases it can be resulted negative even in presence of clinical and epidemiological criteria, and typical radiological and laboratory findings of COVID-19, as we have observed. Here we report our experience in the first month of the Italian epidemic. We strongly recommend clinicians to maintain a high index of suspicion for COVID-19, regardless of the persistence negativity of NP swabs, and not to delay the initiation of therapy in presence of typical clinical, radiological and laboratory findings of COVID-19. (www.actabiomedica.it)