July 2, 2020 | Researchers have discovered that when it comes to antibody test for COVID-19, timing is everything. A strategic partnership is leveraging CRISPR technology for a rapid, point-of-care diagnostic test. Plus more from this week’s COVID-19 news and research in the diagnostics industry.
Research Updates
Cochrane, a global independent organization that reviews evidence from research to inform health decision-making, has reviewed the accuracy of COVID-19 antibody tests. The results were published in the Cochrane Database of Systematic Reviews. Researchers around the world reviewed 54 relevant studies reporting test results for nearly 16,000 samples. They found that antibody tests could have a useful role in detecting if someone has had COVID-19, but that timing is important. The tests were better at detecting COVID-19 in people two or more weeks after their symptoms started, but we do not know how well they work more than five weeks after symptoms started. We do not know if this is true for people who have milder disease or no symptoms, because the studies in the review were mainly done in people who were in hospital. In time, we will learn whether having previously had COVID-19 provides individuals with immunity to future infection. DOI: 10.1002/14651858.CD013652
Industry Updates
Sherlock Biosciences and binx health have entered into a strategic partnership to develop a rapid, point-of-care diagnostic test for COVID-19 leveraging CRISPR technology. The organizations will combine the binx io diagnostic platform with SHERLOCK CRISPR technology to create a test that is robust and simple to use. The currently-available Sherlock CRISPR SARS-CoV-2 kit uses the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) method to program a CRISPR molecule to detect the presence of a specific SARS-CoV-2 genetic signature in specimens collected from patients suspected of COVID-19 by their healthcare provider. The kit is intended for use in CLIA laboratories to assay nasal swabs, nasopharyngeal swabs, oropharyngeal swabs or bronchoalveolar lavage (BAL) specimens. This planned solution with binx health is designed to provide rapid and accurate results in a single patient visit across many diverse CLIA-waived settings, such as clinics, doctors’ offices, assisted living centers, pharmacies and other easily accessible consumer venues. Press release.
Researchers at The University of Texas at Austin are now developing a new sensor that can tell the difference between the two illnesses and test for both simultaneously. The sensor is the size of a micro USB drive and is infused with antibodies of both COVID-19 and influenza. One part of the device is sensitive only to the flu, while another part will react only to the coronavirus. The team has not determined yet how the test would be conducted, but it could be done via saliva samples. The researchers are planning to use inactive samples of COVID-19 and influenza for initial testing of the device, and they will measure how well the sensor connects with the coronavirus's spike proteins, which help it enter human cells by binding with them. Press release.
Researchers from the National University of Singapore (NUS) have developed a portable COVID-19 micro-PCR diagnostic system called Epidax that enables rapid and accurate on-site screening of infectious diseases and significantly reduces the time required to analyze patient samples. Epidax, which is a microfluidics-based PCR diagnostic system, is about the size of a toaster and very portable. It can be deployed quickly and easily on-site for virus infection screening. The Epidax system uses a specially designed microfluidic chip that comprises micro-channels where samples are processed. By employing microfluidic technology, the system is able to process a smaller amount of sample for quicker detection of COVID-19 infection. Using a reagent which enables both RNA extraction and amplification on the chip, the PCR test can be performed right after a nasal swab sample is collected, thus bypassing the intermediate step of RNA extraction. All these features significantly minimize sample handling and shorten the test and waiting time, so patients can get their test results in about an hour. Press release.
Twist Bioscience Corporation has announced the availability of the Twist Respiratory Virus Research Panel, a robust next-generation sequencing (NGS) approach to detecting 29 common human respiratory viruses including SARS-CoV-2, several other coronaviruses, influenzas, rhinoviruses and respiratory syncytial virus. The Twist Respiratory Virus Research Panel targets all common viral pathogens that cause respiratory symptoms in humans. The panel includes both RNA-based and DNA-based viruses in one kit with 41,047 nucleic acid probes. The probes are subject to Twist’s proprietary NGS quality control process, ensuring the probe representation in every lot meets our specifications to provide researchers with high quality, highly uniform capture performance. Press release.
Todos Medical and Meridian Health Services Network are partnering to deploy COVID-19 testing programs throughout the United States. As part of the agreement, Todos will be working closely with Meridian to help supplement COVID-19 testing products and services for its network of brick & mortar and mobile laboratories nationwide. Meridian successfully completed CLIA validation testing for Todos’ antibody test. Press release.
Quantabio’s UltraPlex 1-Step ToughMix was recognized as part of the expanded emergency use authorization (EUA) for the Centers for Disease Control and Prevention (CDC) COVID-19 testing protocol. Public health laboratories facing RNA extraction reagent supply shortages are now advised to use the amended protocol, which includes the one-step, reverse transcription and real-time quantitative PCR (RT-qPCR) kit that provides high assay efficiency, sensitivity and specificity in minimal reaction volumes and accelerated thermal cycling rates. The CDC first added Quantabio’s UltraPlex 1-Step ToughMix and qScript XLT 1-Step RT-qPCR ToughMix to its protocol for the 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel in April 2020. Due to the global shortage of nucleic acid extraction reagents, CDC recently amended the EUA protocol to include a heat treatment methodology, using UltraPlex 1-Step ToughMix, as a viable alternative to RNA extraction. Press release.
Ambry Genetics has launched its CARE for COVID Program to provide employers with the system, tools, and support they need to screen, test, and manage their employees' health with respect to COVID-19 as they return to work. Leveraging the existing Ambry CARE Program, which currently enables hereditary cancer risk-assessment at scale, the CARE for COVID Program helps employers make informed decisions about which employees to test, and how frequently, using an online symptom and exposure questionnaire based on the latest CDC guidelines and recommendations. Ambry is developing a comprehensive testing portfolio to integrate within the CARE for COVID Program to create a comprehensive end-to-end screening, testing, and employee health-management solution. Ambry's initial test offering will be a saliva RT-PCR test for active COVID-19 infection detection, with incremental test options to be rolled out shortly thereafter and will include point-of-care antigen testing. Press release.
GenMark Diagnostics’ ePlex Respiratory Pathogen 2 (RP2) Panel is now available for U.S. commercial distribution and clinical use. The ePlex RP2 Panel is a rapid multiplex test that can identify 21 pathogens, including SARS-CoV-2. The company also submitted an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration for the ePlex Respiratory Pathogen 2 (RP2) Panel earlier this month. The ePlex RP2 Panel is designed to provide results for SARS-CoV-2 in addition to a number of other common respiratory pathogens, including influenza, adenovirus, rhinovirus and respiratory syncytial virus (RSV), in under two hours. The panel also includes a new, simplified workflow making it even easier for labs to run the test. The ability to quickly determine the cause of infections will be vital in the fall and winter when many of these respiratory pathogens are likely to be circulating, along with SARS-CoV-2. Press release.