Earlier Diagnosis of Lyme Disease Possible with Existing and Emerging Technologies—Public Health Watch

It’s not exactly a news flash to note that early diagnosis is key to the successful management of Lyme disease.

However, the antibody testing strategy (typically, enzyme-linked immunosorbent assay followed by Western blot) in use since the mid-1990s has both biological and technological limitations—the most prominent of which is the time needed for the host to make detectable antibody. As Contagion® Public Health Watch reported on September 5, such issues are significant given concerns about global increases in the incidence and prevalence of tick-borne diseases such as Lyme disease.

Enter a group of experts on Lyme disease along with experts in diagnostic tests from industry, academia, and government who met at the Cold Spring Harbor Laboratory Banbury Center in September 2016 to discuss existing diagnostic technologies and the challenges inherent in developing new ones. They presented their views in a paper published on October 11 in Clinical Infectious Diseases.

“Current tests are referred to as ‘indirect’ because they look at the body’s response to an infection rather than detect actual parts of the microbe,” co-author Steven E. Schutzer, MD, professor of medicine, Rutgers New Jersey Medical School, Newark, New Jersey, told Contagion®.

Hence, Dr. Schutzer and his colleagues advocated for further exploration of the viability of “direct tests” for Lyme disease, particularly given that, as they note, “the signs and symptoms of Lyme disease are [often] too nonspecific to be clinically diagnostic.”

Among the tools they recommend:

• Antigen-capture assays, which may be more viable today thanks to, as the authors write, “advances in proteomics, specimen processing, and mass spectrometry.”
• Nucleic acid amplification tests such as polymerase chain reaction (PCR) assays that, Dr. Schutzer and colleagues note, “use unconventional signal detection or amplification methods, with the potential to achieve a limit of detection that is substantially lower than with standard PCR methods.”
• High-throughput sequencing or next-generation sequencing technologies, which have the capability to characterize the genome of Borrelia burgdorferi, the etiologic agent of Lyme disease, and, when used in a targeted form, can identify the microbe (these platforms are also now more affordable than they have been in the past).

“These direct tests can detect the microbe itself or parts of it,” Dr. Schutzer explained. “The methods are being used in direct tests for nucleic acid of several other microbes and those tests are already US Food and Drug Administration-approved. Thus, it would not be a surprise to see these types of tests passing regulatory approval with a year or two.”

Best of all, he adds, there are no additional physical risks to patients in obtaining samples, as they use the same sources (eg, blood and/or bodily fluids) as platforms currently in use.

Which sounds like music to the ears of those with early Lyme disease or at risk for it—in other words: all of us.

Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous health care-related publications. He is the former editor of Infectious Disease Special Edition.