Prognostic bioindicators in severe COVID-19 patients.

BACKGROUND: Severe acute respiratory syndrome caused by novel coronavirus 2 (SARS-CoV-2) emerged in Wuhan (China) in December 2019. Here we evaluated a panel of biomarkers to phenotype patients and to define the role of immuno-inflammatory mediators as biomarkers of severity. MATERIALS AND METHODS: Serum samples were obtained from 24 COVID-19 patients on admission to hospital, before any treatment or infusion of intravenous steroids or invasive ventilation. KL-6 IL-6 and C-peptide were measured by chemiluminescent enzyme immunoassay. IL-6 assay was validated for accuracy and precision. The validity of variables used to distinguish severe from mild-to-moderate patients was assessed by areas under curves (AUC) of the receiver operating characteristic (ROC) and logistic regression was performed to combine parameters of the two groups. RESULTS: In the severe group, IL-6, CRP and KL-6 concentrations were significantly higher than in mild-to-moderate patients. KL-6, IL-6 and CRP concentrations were directly correlated with each other. ROC curve analysis of the logistic regression model including IL-6, KL-6 and CRP showed the best performance with an AUC of 0.95. CONCLUSIONS: Besides corroborating previous reports of over-expression of IL-6 in severe COVID-19 patients requiring mechanical ventilation, analytical determination of other mediators showed that IL-6 concentrations were correlated with those of KL-6 and CRP. The combination of these three prognostic bioindicators made it possible to distinguish severe COVID-19 patients with poor prognosis from mild-to-moderate patients.

Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure.

BACKGROUND: Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process. METHODS: We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority. RESULTS: The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100. CONCLUSIONS: This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.

Detection of autoantibodies against actin filaments in celiac disease.

INTRODUCTION: Serum autoantibodies specifically directed toward intracellular cytoskeletal actin filaments (anti-actin antibodies, AAA) were found to be associated with intestinal villous atrophy (IVA) in celiac disease (CD). The aim of this study was to assess IgA-AAA with a commercial test that uses sections of rat intestinal epithelial cells in a well-selected cohort of patients and to evaluate the relationship between the presence of serum IgA-AAA and the severity of intestinal mucosa damage. MATERIALS AND METHODS: Serum samples from 70 CD patients and 150 controls subjects were analyzed retrospectively for the presence of IgA-AAA. RESULTS: The indirect immunofluorescence test that we used has a specificity of 100%; the sensitivity of the test is not high (25.7%). In this study we also show that serum AAA are more frequently positive in CD patients with total IVA (77.8%) and that this association is significant DISCUSSION: IgA-AAA certainly cannot take the place of much more sensitive tests such as a-tTG and EMA in the diagnosis of CD because of their low sensitivity; nonetheless, these antibodies could be determined in a-tTG and/or EMA positive patients who cannot undergo an intestinal biopsy because of a severe contraindication, or in the case of negative consensus regarding endoscopy, or when the histology interpretation is difficult. CONCLUSION: In conclusion, the IFI commercial test with intestinal epithelial cells as substrate offers a useful method for IgA-AAA determination. Serum IgA-AAA positivity is indicative of more severe intestinal histology damage and their assay could be a real help to the clinician, especially in the complicated cases.