February 12, 2021 | New tools for predicting COVID-19 severity and death, and screening results of more than 1,000 at-home COVID-19 tests. Plus: detecting COVID-19 in wastewater, saliva-based testing for SARS CoV-2, uncovering the immunologic pathways of MIS-C.
Research News
A team from Massachusetts General Hospital (MGH) has created a tool to guide frontline clinicians through diagnostic evaluations of patients they suspect have COVID-19 so that they'll know when it's safe to discontinue precautions. The tool was developed and validated in a study published in Clinical Infectious Diseases. CORAL (COvid Risk cALculator) is a clinical decision support system that guides frontline clinicians through a risk-stratified COVID-19 diagnostic workup, removes transmission-based precautions when workup is complete and negative, and triages complex cases to Infectious Diseases (ID) physician review. In Clinical Infectious Diseases, they report that CORAL significantly reduced the average time to end isolation precautions. DOI: 10.1093/cid/ciab111
After screening more than 1,100 independently assessed, point-of-care COVID-19 tests, researchers at NSF International and Novateur Ventures have identified 5 direct (antigen/RNA) tests for detection of acute infection and 6 indirect (antibody) tests for detection of prior infection that meet the recently published World Health Organization (WHO) "desirable" Target Product Profile (TPP) criteria. Their findings appear in Diagnostics. Topping the list for antigen/RNA tests include at-home tests from DetectaChem, Mammoth Biosciences, and Quidel. The complete list is available in the supplemental materials. DOI: 10.3390/diagnostics11010115
Researchers from Brazil applied an ultrasound examination protocol covering 12 lung regions in 180 COVID-19 patients undergoing treatment at HC. The results showed that the higher the lung ultrasound score, the greater the risk of admission to an intensive care unit (ICU), intubation, and death. They argue that lung ultrasound is a good predictor of the need for intensive care with endotracheal intubation and the risk of death for COVID-19 patients admitted to the emergency room. The authors call it, “a simple, cheap way to estimate the prognosis for patients infected by the virus.” Their findings are published in the Annals of Intensive Care. DOI: 10.1186/s13613-020-00799-w
Researchers in Denmark have developed a machine learning model that can predict the risk of death at the time of a COVID-19 diagnosis with 90% accuracy. Computer scientists from the University of Copenhagen trained a machine learning model on a Danish dataset to predict the risk of an adverse outcome at diagnosis, hospitalization, pre-ICU admission and post-ICU admission. Their ML model was further trained with additional data input, such as physiological parameters, comorbidities, temporal features, and lab results to test its performance as well as reveal links to primary motivators of disease progression. A limited set of demographic variables of age, gender and BMI—BMI being a BMI a primary hallmark of adverse outcome—can predict an adverse outcome (hospitalization, ICU admission, death) as early as diagnosis. Unsurprisingly, comorbidities such as hypertension and diabetes are driving factors of adverse outcomes. Prognostic indicators like CRP levels and markers for organ damage gain significance as the patient moves through the hospital system. Altogether the results indicate that the outcome of a COVID-19 diagnosis can be largely predicted with the relatively limited values of age, gender, and comorbidities, essentially long-hand for frailty. The research is published in Scientific Reports. DOI: 10.1038/s41598-021-81844-x
Industry News
A team of researchers was the recent recipient of a major grant from the National Institutes of Health (NIH) that will help broaden the University of Miami’s pilot program to detect the presence of COVID-19 in wastewater. Because research has shown that people will start excreting the virus in their feces and urine before showing symptoms, detecting traces of the virus in sewage flowing from campus buildings may provide up to a week's notice ahead of positive COVID-19 test results that could warn students and faculty to get tested and self-isolate, using wastewater as an early warning system for a potential COVID-19 outbreak. With the boost in funding from the NIH the team will be able to expand and further evaluate new technologies for collecting, concentrating, and detecting the virus in wastewater while exploring the relationship between the environmental concentration of the virus and the results of human testing to create an infectious disease model that could anticipate potential COVID-19 outbreaks. Next-generation sequencing technology will allow the team to characterize SARS CoV-2 genetic variations, look for novel viruses, and link this data to national and global efforts to track emerging pathogens. Press Release
ProPhase Labs has begun saliva-based testing that integrates the Spectrum Solution saliva self-collection system with a new multiplex qPCR platform for simultaneous RNA detection of SARS CoV-2, as well as its mutations, and Influenza A and B. The SDNA Viral saliva-based testing combo features painless self-collection and a safer sample collection process. Emergency use authorization applications have been filed and ProPhase has received confirmation of a formal review from the FDA device division. Press Release
Nanomix has submitted an Emergency Use Authorization request to the FDA for their eLab COVID-19 rapid antigen test. The assay, which runs on the portable Nanomix eLab analyzer, provides results in 15 minutes and can be used in a range of settings. This platform allows medical professionals, but also employers to test for SARS CoV-2 antigens with a nasal swab that can be self-administered. Press Release
The NIH is sponsoring a Stanford University School of Medicine study using the Fluidigm mass cytometry technology and the Maxpar Direct Immune Profiling Assay in a longitudinal study of approximately 250 pediatric patients infected with SARS CoV-2. With blood samples collected at 20 clinical sites and sent to Stanford, the study will compare data on immune system activity in SARS-CoV-2 positive children with asymptomatic infections, mild COVID-19 infections, and multisystem inflammatory syndrome (MIS-C). The potentially life-threatening MIS-C typically begins several weeks after SARS-CoV-2 exposure and little is known about the immunologic mechanisms. A principal goal of the study is to characterize the immunologic pathways associated with different disease presentations and outcomes. The study is expected to enroll about 250 SARS-CoV-2 infected patients under age 21 from diverse racial and ethnic backgrounds. Press Release
Thermo Fisher Scientific has announced the launch of its CE-IVD-Marked, Applied Biosystems TaqPath COVID–19 HT Kit. This high-throughput solution, compatible with the Amplitude platform, will enable clinical and public health laboratories to test up to 8,000 COVID-19 samples per day with fewer staff. The automated Amplitude platform is a molecular diagnostic platform combining real-time PCR and a supply agreement and monthly delivery of reagent to scale testing for COVID-19. The diagnostic assay also received Interim Order Authorization from Health Canada on January 21. Press Release
The NIH is sponsoring a Stanford University School of Medicine study using the Fluidigm mass cytometry technology and the Maxpar Direct Immune Profiling Assay in a longitudinal study of approximately 250 pediatric patients infected with SARS CoV-2. With blood samples collected at 20 clinical sites and sent to Stanford, the study will compare data on immune system activity in SARS-CoV-2 positive children with asymptomatic infections, mild COVID-19 infections, and multisystem inflammatory syndrome (MIS-C). The potentially life-threatening MIS-C typically begins several weeks after SARS-CoV-2 exposure and little is known about the immunologic mechanisms. A principal goal of the study is to characterize the immunologic pathways associated with different disease presentations and outcomes. The study is expected to enroll about 250 SARS-CoV-2 infected patients under age 21 from diverse racial and ethnic backgrounds. Press Release