IGeneX launches three new tests to aid diagnosis of Borreliosis

Oct 16 2017

IGeneX Inc., a CLIA and New York-approved Reference Laboratory, specializing in testing for tick-borne diseases, is pleased to announce the launch of three new tests that are more inclusive and specific for aiding in diagnosis of Borreliosis (Lyme Disease and Tick-Borne Relapsing Fever, Borreliosis).

-- Lyme ImmunoBlotIgM and IgG

-- Lyme ImmunoBlotIgM and IgGTBRF ImmunoBlot IgM and IgG

-- Lyme ImmunoBlotIgM and IgGTBRF ImmunoBlot IgM and IgGLyme IGX Spot

-- Lyme ImmunoBlotIgM and IgGTBRF ImmunoBlot IgM and IgGLyme IGX Spot

Borreliosis is caused by two groups of Borrelia, B. burgdorferi group and the Tick-Borne Relapsing Fever (TBRF) Borrelia group. Until recently, it was believed that B. burgdorferi group was the only group that caused Lyme-like symptoms. However, we now know that TBRF Borrelia also causes Lyme-like symptoms. Therefore IGeneX developed two sets of Immunoblots, Lyme ImmunoBlot IgM and IgG and TBRF ImmunoBlot IgM and IgG.

Many patients with Lyme-like symptoms are misdiagnosed because: (1) The current serological tests cannot detect antibodies to all the different strains of B. burgdorferi (2) For TBRF Borrelia, only two serological tests, an IFA test for B. hermsii and a serological test that detects only B. miyamotoi GlpQ protein, are available. In addition, with the increase in tick populations, Borreliosis is on the rise. Thus there is an urgent need for better diagnostic tests for Borrelisosi.

Because symptoms of Lyme and Tick-Borne Relapsing Fever are often similar, a more comprehensive battery of tests is critical for proper diagnosis.

"IGeneX's new Lyme ImmunoBlot and the TBRF ImmunoBlot tests are the first, most inclusive and specific serologic tests for Lyme disease and TBRF," said Dr. Jyotsna Shah, President and CEO of IGeneX. "These tests, when combined with Lyme IgX spot and PCR, cover the full spectrum of the disease."

Lyme ImmunoBlots IgM and IgG

Although IGeneX Lyme Western blot prepared from Borrelia burgdorferi strains B31 and 297 is one of the most sensitive tests, it does not detect antibodies to all the B. burgdorferi sensu lato antigens. To develop all inclusive Western blots would be very expensive and impractical. Therefore, IGeneX has developed a Lyme ImmunoBlot that is very specific and inclusive of most species of B. burgdorferi sensu lato for clinical use with the following advantages over a Western blot:

• The specificity of the ImmunoBlot is 98.0% for IgM and 98.7% for IgG. This is higher than the traditional Western Blot.
• The 31kDa Epitope confirmation test will not be required on patient samples tested by Lyme ImmunoBlots.
• The sensitivity of the Lyme Immunoblot is 90.9% with well-defined samples.
• The ImmunoBlot has better sensitivity compared tothe current Western Blot, because it t is designed to detect antibodies to major B. burgdorferi sensu lato specific antigens from North America and European strains as listed below:
  B. burgdorferi B31
  B. burgdorferi 297
  B. californiensis
  B. mayonii
  B. afzelii
  B. garinii
  B. spielmanii
  B. valaisiana

TBRF ImmunoBlots IgM and IgG

The TBRF ImmunoBlot is designed to detect antibodies to specific antigens of TBRF Borrelia in human serum. It detects antibodies to B. hermsii, B. miyamotoi, B. turicatae and B. coriaceae. Based on in-house studies these blots detect antibodies to North American, European and Australian strains of TBRF Borrelia in patient serum samples. The specificity of the TBRF ImmunoBlot is 94% and 98% for IgM and IgG respectively.

Lyme IGX Spot

The Lyme IGXSpot is an Enzyme-Linked ImmunoSpot (ELISPOT) assay that detects human T cells reactive to B. burgdorferi specific antigens in vitro. ELISPOT is a widely used method for detecting and monitoring cellular immune responses to specific antigens.

The Lyme IGX Spot test:

1. Detects specific T-cell responses soon after B. burgdorferi infection, when antibodies to the organisms are not detectable or late in the disease, when the levels of antibodies are very low.

2. When combined with Lyme ImmunoBlot tests, information on the full spectrum of patient's immune response to infection and stage of disease is obtained.

3. Is especially useful for seronegative patients.