Boston Biomedica, Inc. Announces New Lyme Disease Test

A recent discovery has resulted in a promising new Lyme disease test. The C6 Lyme Peptide ELISA (C6 LPE), recently made available by BBI Clinical Laboratories of New Britain, CT identifies antibodies to a newly discovered consistent surface protein that is present on every known strain of the Lyme disease bacteria, Borrelia burgdorferi (Bb).

Researchers believe part of the reason Bb is able to evade immune system response is its ability to use "antigenic variation." This process allows the bacteria to change its genetic composition to evade an immune system response from its hosts. One study (Zhang, Norris,) found that the organisms' Variable major proteins sequence (VMP) changes on days 4,7,14,21,28, and 7 and 12 months post infection of mammalian hosts.

In a significant scientific breakthrough, scientists recently discovered 6 surface proteins on the bacteria that remain constant. Scientists call these "invariable regions" (IR), which are termed IR1-6. One IR, IR6 is found in all strains of the Lyme disease pathogen and induces a strong immune response in infected patients. The C6 LPE detects antibodies to the IR6 in infected patients.

"I am very excited. This test may identify many cases of Lyme that current tests often miss," said Lyme Disease Foundation chair Karen Vanderhoof-Forschner. "It may have the potential to become the standard test for Lyme disease."

Diagnosis of Lyme disease has been hampered by tests that have not been standardized, are not reproducible, and are neither sensitive nor specific for this often difficult to diagnose tickborne disease. The recent Lyme disease vaccine, which has been given to thousands of people over the past year makes current tests for Lyme disease virtually useless. The C6 LPE has several features that ensure its accuracy and reproducibility in a wide range of patients.

Such patients include:

a. Patients that have received the Lyme disease vaccine. Unlike the ELISA and Western blot, the C6 LPE will not cross-react with antibodies to the active ingredient of the vaccine, Outer surface protein A (OspA).

b. Ability to detect antibodies to all US and European strains of B. burgdorferi, because this protein is common to all presently known strains of the bacteria.

c. Patients with autoimmune diseases (e.g. non-Lyme arthritis, lupus erythematosis), other spirochetal diseases (syphilis, relapsing fever), neurologic conditions, and infectious diseases. Because the C6 LPE is highly specific, people with autoimmune diseases do not yield false positive results as they often do with current Lyme tests.

d. Since IR6 antibodies begin to be produced in early infection and are produced throughout the course of infection, the C6LPE is more sensitive for diagnosing all stages of Lyme disease, including those patients with late stage Lyme disease.

BBI Clinical Laboratories offers a comprehensive range of carefully validated tests for tickborne pathogens including confirmatory tests for Lyme disease, tests for human ehrlichiosis, and another tickborne pathogen, Babesia microti.

BBI Clinical Laboratories specializes in testing for a broad range of infectious agents including HIV and Hepatitis viruses, offering services in itís Immunology, Microbiology, and Molecular Diagnostics laboratories to physicians, hospitals, clinics, and other reference laboratories.