FDA Cleared Lyme Disease (Borrelia burgdorferi B31) Line Immunoassay

GSD offers both a highly specific line immunoassay (LIA) confirmation test and sensitive ELISA screen to fulfill the CDC's recommended Lyme disease diagnostic process. The LIA offers numerous improvements compared to traditional Western blot technology.

Please contact us for ordering information.

 

 

Line Immunoassay (LIA) Advantages

  • Discrete Antigen Application - Antigen applied in tightly defined, discrete positions on each strip.
  • Native Antigen Structure – The 3D (tertiary) structure is maintained for LIA. Western blot proteins are denatured, and only their primary structure remains intact. Antibodies bond with proteins in their native structure.
  • Intuitive Results – Easy-to-read, precisely defined results. No special Band Locater or subjective judgment required.
  • Easy Handling - Strips fixed in a numbered booklet (32 strips per booklet).
  • Durable Strips - Strip booklet stabilized with plastic backing.
  • Automation - Standardized strips are suitable for automation.

Simple Procedure

  • Identical Serum Dilution (1:100)
  • Internal Test Controls (Serum & Conjugate bands)
  • Quick results (100 minutes: 30/30/10) 

 


Line Immunoassay (LIA) vs. Western Blots

Line Immunoassay strips offer easy handling, simple procedures and intuitive interpretation. Results can be read by virtually anyone with minimal training and experience.

Traditional “Western Blots” are not intuitive to read and require a Band Locator to interpret results.

 


The Line Immunoassay (LIA) Test Strip

100% Quality Control

GSD’s Line Immunoassays are thoroughly examined by testing two strips from each nitrocellulose sheet using a positive control.

 


Borrelia burgdorferi B31 Added to CAP Survey

GSD's Borrelia burgdorferi B31 Line Blots for the confirmation of Lyme disease have been added to the CAP Proficiency Testing Program as part of the Tick-Transmitted Disease (TTD) panel. 

 


 

Borrelia Antigens

Important Borrelia IgG Antigens

Proteins:

  • p83/93/100) - Late Stage Marker
  • Oms66 (p66)
  • OppA-2 (p58) - Disseminated Stage Marker
  • Heat Shock (p45)
  • Flagellin (p41) - Flagella Protein
  • BmpA (p39) - Membrane Protein
  • OspA (p31)
  • Surface Proteins (p30, p28, p18)
  • OspC (p23) - Early Marker Surface Protein

Legend

  • Weight: Antigen weight in kiloDaltons (purified or recombinant)
  • Protein: protein name (if available).

Stage

  • Early – Early localized infection
  • Disseminated– Early disseminated infection(e.g. “neuroborreliosis”)
  • Late – Late persistent infection.

Important Borrelia IgM Antigens

Proteins:

Legend

  • Weight: Antigen weight in kiloDaltons (purified or recombinant)
  • Protein: protein name (if available).

Stage

  • Early – Early localized infection
  • Disseminated– Early disseminated infection(e.g. “neuroborreliosis”)
  • Late – Late persistent infection.

 


Lyme Disease (Borrelia burgdorferi) General Information

Lyme map

Lyme disease is caused by three species of Borrelia bacteria: Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii. Most cases in the United States are caused by the Borrelia burgdorferi strain. The vast majority of cases are concentrated in the Northeast and Midwest United States, with over 94% of 2010 cases occurring in just 12 states in those regions.

Helpful Links from the CDC

Lyme Disease Data - Cases by State, Maps and other disease data.

CDC Communications Tool Kit - Sign up to receive news about Lyme disease activity and learn how to prevent Lyme disease. 

 

More information: www.cdc.gov/lyme

 


Borrelia burgdorferi Diagnostics Studies

  1. Burgdorfer, W., Barbour, A. G., Hayes, S. F., Benach, J. L., Grunwaldt, E., and Davis, J.P. Science 516:1317-1319, 1982.
  2. Steere, AC. N. Engl. J. Med. 321:586-596, 1989.
  3. Steere A.C., Taylor E., Wilson M.L., Levine J.F., and Spielman A. J. Infect Dis. 154:295-300, 1986.
  4. Aguero-Rosenfeld M., Nowakowski, J., McKenna D, Carbonaro C, and Wormser, G. J. Clin. Micro. 31:12 3090-6095, 1993.
  5. Steere, A. C., Grodzicki, R. L., Kornblatt, A. N., Craft, J., E. .Barbour, A., Burgdorfer, W.G., Schmidt, G. P., Johnson, E., and Malawista, S. E. N. Engl. J. Med. 308:733-740, 1983.
  6. U.S. Dept of Health and Human Services, FDA, CDRH. Draft Guidance for Industry and Food and Drug Administration Staff. Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi. Jan 2011.
  7. Centers for Disease Control and Prevention. Morbid, Mortal, Weekly Rep. 44:590-591, 1995.
  8. Dressler F,Whalen, J. A., Reinhardt B. N., and Steere, A. C. J. Infect. Dis. 167:392-400, 1993