SEE GRAPHS AT SITE!!Lyme Disease (Borrelia burgdorferi B31) Line Immunoassay
JUNE 2012
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Ordering Info
IgM Antigens
IgG Antigens
Lyme LIA
LIA vs. Western Blot
LIA Advantages
Test Strip Details
Package Inserts IgG, IgM
Quality Control
Lyme Studies
Lyme General Info
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, and the ELISA can be easily automated on the innovative ThunderBolt™ EIA Platform.
GSD’s Lyme disease ELISA is fully validated as “ThunderBolt-Ready” ensuring quick and easy implementation in any laboratory environment.
In addition to Lyme disease, over 200 other assays from 20 different manufacturers are also certified “ThunderBolt-Ready”.
Important Borrelia IgM Antigens
Proteins:
Flagellin (p41) - Marker, Flagella Protein
BmpA (p39) - Membrane Protein
OspC (p23) - Early Lyme 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 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.
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.
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)
Calibration via Cut-Off Control Band
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 bergdorferi Diagnostics Studies
Burgdorfer, W., Barbour, A. G., Hayes, S. F., Benach, J. L., Grunwaldt, E., and Davis, J.P. Science 516:1317-1319, 1982.
Steere, AC. N. Engl. J. Med. 321:586-596, 1989.
Steere A.C., Taylor E., Wilson M.L., Levine J.F., and Spielman A. J. Infect Dis. 154:295-300, 1986.
Aguero-Rosenfeld M., Nowakowski, J., McKenna D, Carbonaro C, and Wormser, G. J. Clin. Micro. 31:12 3090-6095, 1993.
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.
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.
Centers for Disease Control and Prevention. Morbid, Mortal, Weekly Rep. 44:590-591, 1995.
Dressler F,Whalen, J. A., Reinhardt B. N., and Steere, A. C. J. Infect. Dis. 167:392-400, 1993
Lyme Disease (Borrelia bergdorferi) General Information
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.
More information: http://www.cdc.gov/lyme/
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PAULIE, OUTSTANDING FIND; thanks for sharing my friend!
hugs/prayers,
bettyg, iowa activist
Post edited by: Bettyg, at: 06/28/2012 01:12 AM
