Responsiveness in the face of public health challenges has long been a hallmark of the clinical laboratory community. In recent years, that ability has been tested repeatedly by the emergence of infectious diseases that can cause significant health consequences, and yet are difficult to diagnose in clinically meaningful timeframes.
But diagnostics developers are making headway. Earlier this year we reported that FDA had authorized the marketing of the ZIKV Detect 2.0 IgM Capture ELISA from InBios International as the first diagnostic test to receive market clearance for detecting Zika virus immunoglobulin (IgM) antibodies in human blood.
And in October, the agency allowed marketing of the OraQuick Ebola rapid antigen test from OraSure Technologies as the first rapid diagnostic test for Ebola virus disease available on the US market.1 The test detects Ebola virus antigens in human blood from living individuals, and in samples from recently deceased individuals suspected to have died from Ebola. The test provides a rapid, presumptive diagnosis that must be confirmed. “The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially lifesaving,” said Acting FDA Commissioner Ned Sharpless, MD. “Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials.”
Researchers are also taking on Lyme disease, which is known to be difficult to diagnose because it causes a wide range of symptoms, from fever and rash to neurologic and cardiac symptoms and joint pain. The disease is caused by Borrelia burgdorferi, a spiral-shaped bacterium transmitted by deer ticks. In a recent study, researchers describe a new rapid assay for Lyme disease that could lead to a practical test for use by healthcare providers.2 Using several biomarkers to detect Lyme disease infection, the researchers found that their assay was more sensitive than current laboratory-based tests when diagnosing Lyme disease early after suspected infection. While the assay will require more refinement and testing before it can be authorized as a diagnostic, the researchers say that their results show great potential.
- FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens [press release, online]. Silver Spring, Md: FDA, 2019. Available at: www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-rapid-diagnostic-test-detecting-ebola-virus-antigens. Accessed October 15, 2019.
- Arumugam S, Nayak S, Williams T, et al. A multiplexed serologic test for diagnosis of Lyme disease for point-of-care use. J Clin Microbiol. Epub before print, October 9, 2019; doi: 10.1128/JCM.01142-19.
Chief Editor, CLP
Featured image: Microphotograph of the Lyme disease spirochete, Borrelia burgdorferi, an obligate parasite that cycles between ticks and vertebrate hosts. B. burgdorferi alters the proteins expressed on its outer surface, depending on the state of each host. Researchers used immunofluorescent antibodies to identify spirochetes that express outer surface protein D (yellow and red) and merged the image with an image of all the spirochetes labeled with an anti-B. burgdorferi antibody (green). Image courtesy National Institute of Allergy and Infectious Diseases.