Issues with the current diagnostic methods of Lyme borreliosis:

  • the most frequently used test, serology, is not reliable, especially in the early stage of the disease, and after treatment
  • direct diagnostic methods may fail because of the low number and fast decomposition of Borrelia in the sample
  • cultivation and PCR has low yield in samples that can be easily obtained (e.g. blood)

DualDur is a cell technology medium and a preparation method that

  • conserves the blood or CSF sample for 2-3 weeks, including the Borrelia contained within
  • concentrates the Borrelia 1000x
  • directly investigates the concentrate
  • is based on a completely different concept than other methods

 

The fragile nature of Borrelia

Spirochetes are gram-negative, motile, spiral bacteria, from 3 to 500 microns (1 m = 0.001 mm) long. Spirochetes are unique in that they have endocellular flagella (axial fibrils, or axial filaments).

The spirochete Borrelia Burgdorferi s.l., in a broader sense is responsible for Lyme disease.

Borrelia Burgdorferi is a very sensitive pathogen. Its preferred ambient temperature is 35°C, and requires a special culture medium, different from those used for cultivating other bacteria.

Without DualDur reagent, the disintegration of borrelia starts almost immediately in fresh blood.

 

The drawbacks of the most frequently used diagnostic testing, serology:

The use of serology in Lyme borreliosis is very much debated. The two-tier investigation method, ELISA and Western-blot admittedly fails by low sensitivity in several cases, especially in:

  • the early stage of the disease (see reference)
  • low-endemic areas (see reference)
  • so-called sero-negative Lyme disease when immune reaction is absent or late
  • false positive cases, when the patient has been immunised, from cross-reaction by spirochetes or viral infections
  • Lupus (SLE) or other autoimmune diseases

Hence, serology can be an excellent tool to increase specificity for a patient with a known infection, but not a screening tool for the early stage.

Serology has a high sensitivity in the disseminated or late phase of the disease. However, by this time the spirochetes have already invaded the body, neurologic or cardiac manifestations, arthritis or chronic neurologic abnormalities may be present.

 

The nature of DualDur

Already a few hours after the tick-bite, Borrelia may get into the bloodstream of the host, and start disseminating. However, even in the late and severe cases of Lyme borreliosis, borrelia may be present in the blood in relatively low numbers. Sometimes only a few bacteria may be found in a whole ml of blood.

In order to investigate only the spirochetes, DualDur medium and method separates the low-weight bacterial content of the blood and concentrates them at least 1,000 times. This is done in a safe way so the bacteria are not harmed and show normal signs of life, they even multiply.