Study exposes inaccuracy of new test for Lyme disease

July 8, 2016

Looks like marketing and publicity might have outpaced the validity and usefulness of a test used to detect Lyme disease.

Looks like marketing and publicity might have outpaced the validity and usefulness of a test used to detect Lyme disease. Researchers report in a new study that structures identified as Borrelia- and Babesia by the new microscopy technique, LM-method, were found to a similar degree in healthy controls. The LM-method yields false-positive results and should not be recommended to identify people with potential Borrelia or Babesia infections, according to the study.

Researchers conducted this study on the heels of research suggesting that modified microscopy techniques, or the LM-method, could, within one or two days, detect active Lyme disease caused by Borrelia bacteria and the tick-borne parasite Babesia. The study touting the LM-method, however, did not have a control group, nor did it have methods that were validated for use in patients.

Amid high patient demand for the test in Norway, researchers at the Norwegian Institute of Public Health decided to investigate the new test’s reliability. They collected blood samples from 21 people who had been suffering from Lyme disease-like symptoms for several years and previously tested positive for Borrelia and/or Babesia by the LM-method and compared those to 41 healthy controls. Samples were masked and analyzed in independent laboratories using diagnostic tests including the LM-method, conventional microscopy, genetic fingerprint testing (PCR) and serology.

The LM-method identified structures as Borrelia- and/or Babesia in 66 percent of blood samples from the active group and 85 percent of controls. Conventional microscopy for Babesia only did not identify Babesia in any samples. PCR analysis detected Borrelia DNA in one sample of the patient group and in eight samples of the control group. And Babesia DNA was not detected in any of the samples using molecular methods.

In an editorial commentary, Ram B. Dessau, MD, PhD, infectious disease specialist and senior consultant at Slagelse Hospital, Slagelse, Denmark, writes: “I hope the study serves as a warning against non-validated microscopic procedures and helps prevent mismanagement of patients with chronic complaints, who are lured to seek improper diagnosis in the future.”