Evaluation of a rapid and sensitive RT-qPCR assay for the detection of Ebola Virus.

BACKGROUND: The 2013-2016 Ebola virus disease (EVD) outbreak showed a lack of diagnostic point-of-care methods. Currently, EBOV diagnosis relies on quantitative reverse-transcription-PCR (RT- qPCR), highly specific and sensitive, but requiring skilled personnel and well-equipped laboratories. In field settings, these factors and others, such as samples' time of collection and transportation, determine a prolonged turnaround-time to final results. In outbreak scenarios, a rapid and transportable method could eliminate issues of cohorting suspected and actual EVD patients for lack of diagnostic certainty. The aim of this study was the field evaluation of the new fast, easy-to-use and reliable RT-qPCR assay and platform for EBOV detection, developed in the framework of the EbolaMoDRAD project by CLONIT S.r.l. and STMicroelectronics S.r.l. STUDY DESIGN: We evaluated its performance during the outbreak and in further studies in the EVD laboratory at the Princess Christian Maternity Hospital (PCMH) in Freetown (Sierra Leone) run by Emergency NGO and the Italian National Institute for Infectious Diseases (INMI). The assay was tested on residual aliquots of clinical specimens from EBOV-positive or -negative patients (n=116, EVD prevalence 37%). RESULTS AND CONCLUSION: Overall, the test was very easy-to-use and the instrument was robust and reliable in field-settings. The sensitivity of the assay was 100% and the specificity was 98.63% (95%CI: 96.34-100.92%). The positive and negative predictive values were 97.73 (95%CI:94.77-100.68%) and 100%, respectively. The high sensitivity and specificity of this new assay indicate that it is promising for laboratory diagnosis, especially in resource-limited settings.

EBOLA Ag K-SeT rapid test: field evaluation in Sierra Leone.

OBJECTIVES: Efficient interruption of Ebola virus disease (EVD) transmission chains critically depends on reliable and fast laboratory diagnosis. We evaluated the performance of the EBOLA Virus Antigen Detection K-SeT (EBOLA Ag K-SeT), a new rapid diagnostic antigen test in field settings. METHODS: The study was conducted in a field laboratory located in Freetown (Sierra Leone) by the Italian National Institute for Infectious Diseases 'L. Spallanzani' and the EMERGENCY Onlus NGO. The EBOLA Ag K-SeT was tested on 210 residual plasma samples (EVD prevalence 50%) from patients hospitalized at the EMERGENCY Ebola treatment center in Goderich (Freetown), comparing the results with quantitative real-time PCR. RESULTS: Overall, the sensitivity of EBOLA Ag K-SeT was 88.6% (95% confidence interval (CI), 82.5-94.7), and the corresponding specificity was 98.1% (95% CI, 95.5-100.7). The positive and negative predictive values were 97.9% (95% CI, 95.0-100.8) and 89.6% (95% CI, 84-95.2), respectively. The sensitivity strongly increased up to 98.7% (95% CI, 96.1-101.2) for those samples with high virus load (≥6.2 log RNA copies/mL). CONCLUSIONS: Our results suggest that EBOLA Ag K-SeT could represent a new effective diagnostic tool for EVD, meeting a need for resource-poor settings and rapid diagnosis for individuals with suspected EVD.

[Health-related quality of life in patients with chronic kidney disease]. / Qualita' della vita nei nefropatici.

Assessment of quality of life in patients with different degrees of chronic kidney disease is an important issue because of its impact on clinical decisions and financial resource management in the health-care system. The aim of this study was to assess whether a generic instrument like the SF-36 questionnaire is able to discriminate three different populations of patients with different degrees of renal disease (pre-ESRD, ESRD, TxR). Five hundred sixty-three patients from 12 Italian nephrology units completed the SF-36 scales by themselves. The results from these samples were compared with those from the general population. Univariate analysis and multivariate regression were used. The generic SF-36 questionnaire proved to be a powerful instrument to discriminate populations with different degrees of chronic renal failure. The quality of life of patients on dialysis is significantly worse than that of the normal population and other patients with less severe renal function impairment.

[Evaluation of quality of life by improving the uraemic anaemia status]. / Miglioramento dello stato anemico e valutazione della qualita' di vita del paziente in trattamento dialitico sostitutivo. Applicazione del ciclo dell'"audit" ad una unita' di nefrologia e dialisi.

BACKGROUND: Anaemia is one of the most common signs of chronic uraemia that determines an increase in both morbidity and mortality, as well as a deterioration in the quality of life of affected patients. We evaluated the impact of the application of the European Best Practice Anaemia Guidelines to the quality of life of dialysed patients. PATIENTS AND METHODS: We studied for 12 months (from December 2000 to November 2001) 62 patients in haemodialysis and 22 patients in peritoneal dialysis. For the statistical analysis the following parameters were examined: haemoglobin levels, TSAT, and weekly doses of Epo. To assess the quality of life we asked the patients, at the initial visit and 12 months after treatment, to fill out the "Medical Outcome Study Short Form 36 items Heath Survey" and "Kidney Disease Quality of Life". RESULTS: The significant increase in TSAT levels attained in haemodialysed patients (p = 0.03) induced an increase in haemoglobin levels and consequent reduction in EPO administration (p = 0.04). During the study, a significant improvement in General Health (GH) (p = 0.03) was observed. At the end of the treatment, Physical Functioning (PF) (p = 0.04), Role and Physical Health (RP) (p = 0.02) and Social Functioning (SF) (p = 0.005) showed significant variations. CONCLUSIONS: The application of the European Best Practice Anaemia Guidelines improves the management of anaemia and the Global Health Assessment in uraemic patients. These data demonstrate how inappropriate anaemia management can negatively affect the quality of life of these patients and increase the medical costs.

Propranolol, clonidine, urapidil and trazodone infusion in essential tremor: a double-blind crossover trial.

Accelerometric tremorgrams were recorded from 25 subjects affected by essential tremor and analysed by a Berg-Fourier frequency analyser before and during venous infusion of the following drugs: propranolol (beta-blocker), clonidine (alpha-presynaptic adrenergic agonist), urapidil (alpha-postsynaptic blocker), trazodone (adrenolytic agent) and placebo. The washout interval between infusions was 3 days. Recordings and data analyses were performed in a double-blind crossover trial. Tremor was classified as: at rest; postural (arms hyperextended); and intention (finger-nose test). Analysis of the results showed that propranolol and clonidine reduced significantly (P = 0.01 and P = 0.009, respectively) the power spectrum of postural tremor, but left at rest and intention tremors unchanged. No significant effects on the tremor power spectrum were observed after placebo, urapidil or trazodone administration. None of the drugs had any effect on tremor frequency.

[A provincial analysis of fetal and infant mortality in Italy: 1974-1986]. / Un'analisi provinciale della mortalita feto-infantile in Italia: 1974-1986.

PIP: The authors analyze changes in fetal, neonatal, and infant mortality in Italy between 1974 and 1986. Fetal death and mortality during and after the first week are examined by province and region.^ieng