Real-world clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a systematic review of available trials as per April, 4, 2021

Point-of-care assays offer a decentralised and fast solution to the diagnosis of SARS-CoV-2 and provide benefits for patients, healthcare workers, healthcare facilities and other environments. This technology has to potential to prevent outbreaks, enable faster adoption of life-changing measures and improve hospitalar workflow. While reviews regarding the performance of those assays exist, a review focused on the real-life clinical performance and point-of-care feasibility of those platforms was missing. Therefore, the objective of this study is to help end users (clinicians, healthcare providers and organisations) to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities, or inside hospitals. 871 studies were screened in 3 major databases and 51 studies were included, evaluating 20 antigen tests and 10 nucleic-acid amplification platforms. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs in our inclusion criteria. We also investigated package inserts, instructions for use, comments on published studies and manufacturers websites in order to assess feasibility of POC placement and additional information of relevance to the end user. Apart from sensitivity and specificity, we present information on time to results, hands-on time, kit storage, machine operating conditions and regulatory status. To the best of our knowledge, this is the first review to systematically evaluate POC test performance in real-life clinical practice. We found the performance of tests in clinical practice to be markedly different from the manufacturers reported performance and laboratory-only evaluations in the majority of studies. Our findings may help in the decision-making process related to SARS-CoV-2 test in real-life clinical settings.Rationale for the reviewA review focused on the real-life clinical performance and point-of-care feasibility of SARS-CoV-2 diagnostic platforms was missing, impairing the ability of individuals, healthcare providers and test providers to make informed decisions on the adoption of such platforms.Objective(s) or question(s) the review addressesThe objective of this study is to help clinicians, healthcare providers and organisations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities or in complex hospitalar environments.

Olmi and Pasolini: Industrialisation, the underdog and ‘ecological eschatology’ in Manon finestra 2 (1956) and Grigio (1957)

This article focuses on the collaboration between Ermanno Olmi and Pier Paolo Pasolini. Two key figures of the Italian cinematic tradition, Olmi and Pasolini have joined efforts on two occasions, as the Bergamasque director asked Pasolini to provide a commentary for his short films Manon finestra 2 (1956) and Grigio (1957). Two very different products, the two shorts offer a very compelling take on the process of industrialisation taking place in Italy in the 1950s. While Manon presents a slightly more positive view of the transition that Italy has undergone, Grigio is unequivocal in its condemnation, putting forward an alarming thesis: in order for this new society to exist, differences must be erased, communities are to disappear and the least advantaged will be left behind. However, this proposition also has a more optimistic counterpart; namely, the idea that these very communities remain the roots and the true point of reference of our civilisation.

Immuno-biosensor on a chip: a self-powered microfluidic-based electrochemical biosensing platform for point-of-care quantification of proteins

The realization of true point-of-care (PoC) systems profoundly relies on integrating the bioanalytical assays into “on-chip” fluid handing platforms, with autonomous performance, reproducible functionality, and capacity in scalable production. Specifically...

Point of care colourimetric and lateral flow LAMP assay for the detection of Haemonchus contortus in ruminant faecal samples

In this study, we present an optimised colourimetric and a lateral flow LAMP assay for the detection of Haemonchus contortus in small ruminant faecal samples. Using a previously published LAMP primer set, we made use of commercially available colourimetric LAMP and lateral flow kits and combined this into an optimised diagnostic assay which was then tested on field faecal samples from Eastern and South-Eastern Hungary as well as a pure H. contortus egg faecal sample from Košice, Slovakia. Both assays showed no conflicts in visual detection of the results. Additionally, we modified and tested several centrifuge-free DNA extraction methods and one bead-beating egg lysis DNA extraction method to develop a true point of care protocol, as the source of the starting DNA is the main rate-limiting step in farm-level molecular diagnosis. Out of the various methods trialed, promising results were obtained with the magnetic bead extraction method. Sample solutions from the Fill-FLOTAC® technique were also utilised, which demonstrated that it could be efficiently adapted for field-level egg concentration to extract DNA. This proof of concept study showed that isothermal amplification technologies with a colourimetric detection or when combined with a lateral flow assay could be an important step for a true point of care molecular diagnostic assay for H. contortus.

A tandem simulation framework for predicting mapping quality

Read alignment is the first step in most sequencing data analyses. Because a read’s point of origin can be ambiguous, aligners report a mapping quality: the probability the reported alignment is incorrect. Despite its importance, there is no established and general method for calculating mapping quality. We describe a framework for predicting mapping qualities that works by simulating a set of tandem reads, similar to the input reads in important ways, but for which the true point of origin is known. We implement this in an accurate and low-overhead tool called Qtip, which is compatible with popular aligners.