February 19, 2021 | 3-D printed nasopharyngeal swabs could solve resource problems, a closer look at COVID-19 diagnosis in Africa, and new diagnostic from Columbia University. Plus: EUA for COVID-19/flu combo test from Thermo Fisher, at-home tests in validation stages, and new vaccination panel.
Research Updates
A team from the University of Singapore tested whether 3-D printed nasopharyngeal swabs are accurate in detecting SARS-CoV-2. They found that 3-D printed swabs performed comparably with the traditional FLOQSwab (COPAN Diagnostics) and Dacron swab (Deltalab). They propose that 3-D swabs may help mitigate strained resources in the escalating COVID-19 pandemic. They published their findings in JAMA Otolaryngology—Head and Neck Surgery. DOI: 10.1001/jamaoto.2020.5680
A team from Boston and Zambia collaborated to gauge the impact of COVID-19 in Africa. They conducted PCR tests on 364 deceased people of all ages at the University Teaching Hospital morgue in Lusaka, Zambia between June and September 2020, enrolled within 48 hours of death and found SARS-CoV-2 infections in 15% of all sampled deaths—most of whom had not been tested before. “Contrary to expectations, deaths with COVID-19 were common in Lusaka,” the authors write. “Cases of COVID -19 were under-reported because testing was rarely done not because COVID -19 was rare,” they contend. Their work is published in The BMJ. DOI: 10.1136/bmj.n334
A University of Pennsylvania team published research in American Journal of Roentgenology on brain findings from COVID-19 patients. Among 2820 inpatients with coronavirus disease (COVID-19), 59 (2.1%) underwent brain MRI. Of them, six (10.2%) had MRI findings suspicious for COVID-19–related disseminated leukoencephalopathy (CRDL), which is characterized by extensive confluent or multifocal white matter lesions (with characteristics and locations atypical for other causes), microhemorrhages, diffusion restriction, and enhancement. CRDL is an uncommon but important differential consideration in patients with neurologic manifestations of COVID-19. The authors highlight several limitations of their work, but emphasize that leukoencephalopathy represents an uncommon, but important, differential consideration in patients with COVID-19 with neurologic manifestations. DOI: 10.2214/AJR.20.24364
COVID-19 has been linked with eye abnormalities like conjunctivitis and retinopathy. A research team from the French Society of Neuroradiology (SFNR) looked at 129 patients with severe COVID-19 who underwent brain MRI. They found nine patients with abnormal MRI findings of the globe, or eyeball. All nine patients had nodules in the macular region, the area in the back of the eye responsible for our central vision. Eight had nodules in both eyes. The authors suggest that screening should be considered in all patients with severe COVID-19 to detect these nodules. “Screening of these patients might improve the management of potentially severe ophthalmological manifestations of the virus,” they write in their publication in Radiology. DOI: 10.1148/radiol.2021204394
Researchers from Columbia University have developed a new SARS-CoV-2 test with 98% specificity and sensitivity. They created a human coronavirus peptide array and plasma from 50 patients with asymptomatic, mild, or severe SARS-CoV-2 infection to identify immunoreactive IgG epitopes for SARS-CoV-2. Immunoreactivity profiles differed with severity of illness and over the time course of infection. “The HCoV array platform is too complex and expensive for routine clinical microbiology, the authors write. “However, the peptides defined here can be transferred to a wide range of platforms including microarrays, enzyme-linked immunosorbent assay, radioimmunoassay, lateral flow, western blot, and bead-based assays, where they may facilitate diagnostics, epidemiology, and vaccinology.” They published their work in Nature Communications Biology. DOI: 10.1038/s42003-021-01743-9
Industry Updates
The Wyss Institute for Biologically Inspired Engineering at Harvard University and GBS Inc., a subsidiary of The iQ Group Global, announce that they will collaborate to validate and de-risk a specific and sensitive COVID-19 diagnostic that would integrate the Institute's eRapid technology with the company's proprietary transistor sensor technology to enable simultaneous electrochemical sensing of multiple biomarkers related to SARS-CoV-2 infection in point-of-care COVID-19 diagnostic applications. Press release.
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit from Thermo Fisher Scientific. The TaqPath COVID-19, Flu A, Flu B Combo Kit is a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs. The TaqPath COVID-19, Flu A, Flu B Combo Kit helps labs expand their existing COVID-19 testing menu for respiratory samples while maintaining low operational costs and workflow simplicity. The kit includes Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, helping reduce risk of user interpretation error. Press release.
Maverick Health is launching its end-to-end diagnostics and virtual care platform, including the first FDA-approved at home saliva COVID-19 test. Using a cutting-edge technology platform, Maverick Health offers end-to-end diagnostic testing for a variety of conditions, including COVID-19, in a safe, convenient, and efficient manner for individuals and organizations. Press release.
Ellume, producer of next-generation digitally enabled diagnostic solutions, has secured a $231.8 million agreement with the U.S. Government to support accelerated manufacture of its COVID-19 home test. The test makes use of AnteoTech’s unique AnteoBind technology to support significantly improved sensitivity, and is the first rapid self-test for SARS-CoV-2 detection authorized by the United States Food and Drug Administration (FDA) for use without a prescription. Through the patented AnteoBind technology and the expertise and know-how delivered via its Contract Services in assay development and bioconjugation, AnteoTech continues to address the pressing challenges of the point-of-care diagnostics, biopharmaceutical and vaccine development markets. Press release.
BioIVT has introduced its COVID-19 Vaccination Panel, composed of pre- and post-vaccination serum or PBMC samples, to enable researchers to study blood donors’ vaccine-generated immune response. BioIVT has been providing more than 300 clients with biospecimens to support the development of COVID-19 diagnostic assays and therapeutic interventions since the beginning of the pandemic. Those biospecimens have included saliva, serum, plasma, PBMCs, fresh whole blood, bulk plasma, and bulk serum from acute COVID-19 cases and recovered donors, together with representative diagnostic polymerase chain reaction or serological antibody test results to verify infection and /or exposure. BioIVT samples are provided with donor social, demographic and co-morbidity data, together with the date of onset, symptoms, and severity of their COVID-19 infection where available. Press release.