Evaluation of a near-patient SARS-CoV-2 novel rapid diagnostic platform.

The goal of this study is to test a novel device and methodology based on the "Pebble" platform and real-time quantitative colorimetric loop-mediated isothermal amplification (qcLAMP) during SARS-CoV-2 detection using crude samples and extracted RNA. The new method employs an inexpensive lightweight device aimed toward rapid point-of-care testing. An extensive evaluation was performed consisting of 1,693 clinical samples across five independent clinical testing centers.

Rapid identification of SARS-CoV-2 variants: Validation of the simplexa SARS-CoV-2 variant direct assay.

The circulation of certain SARS-CoV-2 variants may have a great impact on the epidemiological status of a geographical area; therefore, it is important that their presence is monitored. Currently, the gold standard method used to identify newly emerged variants is sequencing of either genes or whole genomes. However, since this method is relatively expensive and has a long turnaround time, other rapid strategies should also be employed.

Comparison of two point-of-care respiratory panels for the detection of influenza A/B virus.

Background: Rapid and accurate diagnostics of patients with suspected seasonal influenza or pathogens of the upper respiratory tract is crucial. Fast detection is important especially for influenza A/B virus, so that isolation measures should be taken to prevent the spread of the virus.

Methods: We compared the performance of two syndromic testing methodologies (QIAstat-Dx RP, BioFire RP2plus) against the Alere™ i as the comparator method.

Evaluation of STANDARD M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples.

The SARS-CoV-2 pandemic led to an urgent need for rapid diagnostic testing in order to inform timely patients' management. This study aimed to assess the performance of the STANDARD™ M10 SARS-CoV-2 assay as a diagnostic tool for COVID-19. A total of 400 nasopharyngeal or oropharyngeal swabs were tested against a reference real-time RT-PCR, including 200 positive samples spanning the full range of observed Ct values.

Portable real-time colorimetric LAMP-device for rapid quantitative detection of nucleic acids in crude samples.

Loop-mediated isothermal amplification is known for its high sensitivity, specificity and tolerance to inhibiting-substances. In this work, we developed a device for performing real-time colorimetric LAMP combining the accuracy of lab-based quantitative analysis with the simplicity of point-of-care testing. The device innovation lies on the use of a plastic tube anchored vertically on a hot surface while the side walls are exposed to a mini camera able to take snapshots of the colour change in real time during LAMP amplification.