January 22, 2021 | Quantified smell loss the best predictor of COVID-19 among those with symptoms, the outlook for self-tests, circulating mitochondria as a warning of severe disease, and more. Plus: QIAGEN’s PCR test stands up to new variants, new development on tests to distinguish between SARS-CoV-2 and influenza.
Research Updates
In a preregistered, cross-sectional study, an international team investigated whether olfactory loss is a reliable predictor of COVID-19 using a crowdsourced questionnaire in 23 languages to assess symptoms in individuals self-reporting recent respiratory illness. They found that quantified smell loss is the best predictor of COVID-19 among those with symptoms of respiratory illness. They published their findings in Chemical Senses. DOI: 10.1093/chemse/bjaa081
In a research letter in JAMA Network Open, researchers from Philadelphia explored the factors associated with motivation to use and distribute COVID-19 self-tests. The authors posit that self-tests could increase testing and possibly improve contact tracing by facilitating case detection if test kits are distributed to contacts of infected individuals. In a sample of 586 adults, the majority of survey participants were motivated to distribute COVID-19 self-test kits and to use self-test kits. Motivation is a prerequisite for voluntary behavior, and findings suggest that the secondary distribution of COVID-19 self-test kits may be associated with increased test uptake and case detection. DOI: 10.1001/jamanetworkopen.2020.34001
Circulating mitochondrial DNA is an early indicator of severe illness and mortality from COVID-19, argues a team from Washington University School of Medicine in St. Louis. They developed a relatively simple and rapid blood test to predict—within a day of a hospital admission—which patients with COVID-19 are at highest risk of severe complications or death based on levels of mitochondrial DNA in the blood. The work is in in-press preview at JCI Insight. Mitochondrial DNA spilling out of cells and into the bloodstream is a sign that a particular type of violent cell death is taking place in the body. DOI: 10.1172/jci.insight.143299.
Temperature alone isn't a good indicator of disease, according to a new paper in Experimental Physiology. Not all who have the virus have a fever and many who do, develop one only after admission to hospital and measuring skin temperature doesn't give an accurate estimation of deep body temperature (raised in a fever), the authors write. A direct measure of deep body temperature is, of course, impractical in high traffic areas like airports. Even if a person has a high temperature, it does not mean a person has Covid-19. The authors suggest taking two temperature measurements, one of the finger, the other of the eye, is likely to be a better and more reliable indicator of a fever-induced increase in deep body temperature. DOI: 10.1113/EP089260
Industry Updates
Fluidigm has received the CE-IVD mark for its Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus. The CE-IVD mark is in conformance with the European Union In Vitro Diagnostic Directive. The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the company’s clinical studies for submission demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays. Press release.
QIAGEN has announced its polymerase chain reaction (PCR) tests remain accurate and effective in detecting SARS-CoV-2 infections—and will continue to closely monitor their performance as global concerns mount regarding the detection of new viral variants by established testing methods. QIAGEN has successfully assessed its SARS-CoV-2 PCR tests against genetic mutations of the virus uploaded to the GISAID and GenBank public databases since May 2020. A latest round of assessments conducted in January 2021 again confirmed that no recorded mutations affected the sensitivity of QIAGEN assays for detection of SARS-CoV-2. Surveillance of genetic variations will continue on a biweekly basis. Press release.
Integrated DNA Technologies (IDT) is developing a multiplex RT-qPCR test that can detect and distinguish between SARS-CoV-2, influenza A, and influenza B from a single patient sample. (For more on a combination test for SARS-CoV-2 and influenza, see: Combination Tests Emerge to Tackle Potential “Twindemic”) The new PrimeTime SARS-CoV-2/Flu Test is being submitted by IDT for U.S. Food and Drug Administration Emergency Use Authorization (EUA). The new broad usage test is the first in vitro diagnostic product being developed by IDT. The PrimeTime SARS-CoV-2/Flu Test combines a number of IDT’s components into a single test solution, which will be especially helpful for laboratories that are experiencing supply chain challenges for testing reagents. The IDT test will be able to be utilized as an “open system solution” validated on several different instrument platforms, enabling more widespread use. Press release.
Ignyte Healthcare Strategies is now offering doc.ai’s Passport to their more than one million customers. Passport is doc.ai’s privacy-first COVID-19 evaluation tool designed to create safer re-entry to the workplace. As part of Ignyte’s Return to Work Plan to streamline COVID-19 solutions for customers, Passport will now be included in Ignyte’s portfolio of solutions. By enabling employees and customers to securely assess their health status on their mobile devices, Passport is able to meet the unique needs of each business, as well as county and state-specific requirements. Features allow businesses to easily customize their employees’, visitors’, and customers’ experiences in real-time via a secure dashboard and without additional set up for the employer. Employees and visitors generate a daily badge, an encrypted QR-code, that can be scanned for safe admission into the workplace. Through the use of edge computing, personal health information (PHI) entered into Passport never leaves employees’ mobile phones, ensuring sensitive data remains secure and private while enabling employees to safely return to the workplace. Passport will incorporate immunization and rapid testing records once the COVID-19 vaccine is in distribution and allow for custom integrations with third-party devices that are a part of existing solutions, ranging from smart handheld thermometers to thermal scanners. Press release.