ABSTRACT
The availability of accurate and rapid diagnostic tools for COVID-19 is essential for tackling the ongoing pandemic. In this context, researchers in the UK have started testing a new Lateral Flow Device (LFD) based on proprietary Biotinylated anti SARS-CoV-2 S1 AffimerR technology that binds to the SARS-CoV2-S1 protein in anterior nasal swab samples, generating an ultrasensitive method for detection. This international study aimed to compare its performance against other available Antigen-detecting Rapid Diagnostic Tests (Ag-RDTs) in a real-world clinical setting. The study was completed under the frame of Project SENSORNAS RTC-20176501 in collaboration with MiRNAX Biosens Ltd. and Hospital Carlos III, it was documented internally and deposited in agreement to the ISO 13485 norm. All the data obtained are currently under submission and review from the Ethics Committee of Universidad Autonoma de Madrid.
ABSTRACT
Background and aims: Quick, user-friendly, and sensitive diagnostic tools are the keys to controlling the spread of the SARS-CoV-2 pandemic in the new epidemiologic landscape. The aim of this work is to characterize a new COVID-19 antigen test that uses an innovative chromatographic Affimer..-based technology designed for the qualitative detection of SARS-CoV-2 antigen. As rapid technology to detect COVID-19, the test was extensively characterized in vitro. Once the analytical parameters of performance were set, the test system was challenged in a test field study. The aim of this study was to evaluate its diagnostic accuracy, as compared by the gold standard RT-PCR and other existing lateral flow tests.
ABSTRACT
Background: The implementation of rapid analysis techniques at point-of-care or hospital facilities allows the optimization of the HCV cascade of care. The aim of this work was to develop an integrated rapid diagnosis strategy that includes the identification of patients, samples testing, clinical diagnosis and communication to the Hepatology Unit for referral and treatment. Methods: We recruited patients from Comprehensive Care Centers for Drug Addicts (CAID) and Primary Care Centers (CAP) who met the inclusion criteria: A) risk populations without previous diagnosis of HCV infection, and B) untreated HCV positive patients. The diagnostic cascade consisted of: A) patient recruitment;B) taking samples in the CAID/CAP facilities;C) sample analysis;and D) communication of results to the hospital hepatologists. The HCV-RNA and genotype were analyzed with a rapid kit (HCV-kit, Epistem) and confirmed with the standard diagnostic techniques at the Hospital facilities. Results: All patients referred to the hospital for HCV screening between 01/01/2019 and 03/10/2020 (moment at which the study was discontinued due to COVID-19 pandemics) were included. Sixty patients had a history of parenteral drug addiction. We identified 51 patients with detectable HCV-RNA [3 (6%) from CAIDs]. Five (4%), including 3 patients with active addiction practices, were aware of the HCV infection but they have not been previously treated. All HCV-RNA positive patients were infected with genotype 1. An exact correlation was confirmed between the results obtained with the point-ofcare and hospital standard diagnostic systems. The gap time between the sample reception and the result communication to Hepatology Unit using the point-of-care strategy was in all cases less than 5 hours, allowing the results report in the same day. Antiviral therapy with DAAs was proposed to all patients and all except the 3 from the CAIDs agreed to be treated. Conclusion: A) The point-of-care diagnostic systems were comparable, in terms of sensitivity and specificity, to the standard hospital techniques. B) The use of this strategy allows to the hospital hepatologist to have the necessary data for antiviral treatment prescription in the same day of patient recruitment. C) Re-uptake of patients from vulnerable populations with a previous diagnosis of HCV infection does not guarantee the treatment and this will require the development of additional management strategies of this kind of patients.