Lyme Diagnostics
Total Lyme Testing Solutions

IgG/IgM EIA for Lyme Screening

GSD Lyme IgG/IgM EIA screen is FDA cleared as a qualitative presumptive(first tier) test for Lyme disease, and is optimized for both superior sensitivity and specificity. The simple, easy-to-use kit includes ready-to-use controls and a fast protocol which can easily be automated.

IgG & IgM Immunoblots for Lyme Confirmation

The Lyme Immunoblots are also FDA cleared as qualitative supplementary (second tier) tests for Lyme disease and use all of the CDC recommended antigens. The antigens are evenly and consistently spaced on each strip for easy and accurate interpretation. The assay procedure is simple, standardized, and can be easily automated.

GSD's New B. burgdorferi lgG/IgM VlsE-OspC Assay

Gold Standard Diagnostics' newest Lyme assay includes the recombinant antigens VIsE and OspC to achieve excellent sensitivity and specificity; the sensitivity  is comparable to a standard first tier screening assay and the specificity is comparable to an immunoblot.

The B. burgdorferi  lgG/IgM VIsE-OspC assay uses the GSD Standard Lyme EIA protocol with a 15/15/15 incubation.

The Modified Two-Tiered Testing algorithm (MTTT) for Lyme Disease diagnosis is based on two EIA tests. This is an alternate option to the Standard Two-Tiered Testing algorithm (STTT) in which a positive screen result is confirmed with an immunoblot.

Using the B. burgdorferi  lgG/IgM VlsE-OspC test as the first tier in combination with a second GSD Lyme EIA as the second tier in the MTTT algorithm, we maintain > 98% specificity while demonstrating a nearly 20% increase (1) in Early Lyme Disease detection compared to the STTT.

All Things Lyme

Gold Standard Diagnostics is the only company offering kits in the U.S. to fulfill Lyme testing requirements for both the Standard and Modified two-tiered testing algorithms. Our four EIA kits and two lmmunoblot kits allow flexibility for your lab to meet your clients' needs. All products are FDA cleared, and testing can be fully automated on open processing platforms.


1. Gold Standard  Diagnostics IFU (Instructions For Use) GSD01-1 027 Method Comparison: CDC Reference Panel for Clinical Sample results.

Total IgG/IgM

IgG EIA

IgM EIA

GSD Whole-Cell Sonicate ELISA Kits

GSD Lyme IgG/IgM EIA, IgG EIA, and IgM EIA screens are FDA cleared as qualitative presumptive (first tier) tests for Lyme disease, and are optimized for both superior sensitivity and specificity. These simple, easy-to-use kits include ready-to-use controls and a fast protocol which can be easily automated.

  • SUPERIOR SENSITIVITY

    Includes antigens from B. burgdorferi strains B31 and 2591.

  • OPTIMAL SPECIFICITY

    Contains VIsE immunogenic lipoprotein.

  • CONVENIENT

    Kit includes ready to use controls for ease of use.

  • AUTOMATABLE

    Simple procedure is easy to automate.

Lyme IgG/IgM EIA, IgG EIA, and IgM EIA screens are FDA Cleared and can be easily automated.

IgG & IgM Immunoblots for Lyme Confirmation

  • DISCRETE ANTIGEN APPLICATION

    Includes antigens from B. burgdorferi strains B31 and 2591.

  • NATIVE ANTIGEN STRUCTURE

    The 3D (tertiary) antigen structure is maintained, unlike denatured Western blot proteins which only retain primary structure.

  • INTUITIVE RESULTS

    Easy to read, precisely defined results, withinternal test controls (serum and conjugatebands) and kit positive, negative, and cutoff controls. No special band locater orsubjective judgment required.

  • EASY HANDLING

    Strips are fixed in a booklet with a unique number system.

  • DURABLE STRIPS

    Strip booklet stabilized with plastic backing.

  • FAST AND SIMPLE PROCEDURE

    Protocol includes 1:100 serum dilution with an incubation time of 30/30/10.

  • EASILY AUTOMATED

    Standardized strips are suitable for automation.

GSD Immunoblot Confirmation

  • NATIVE ANTIGEN STRUCTURE

    The 3D (tertiary) antigen structure is maintained, unlike denatured Western blot proteins which only retain primary structure.

  • IgG AND IgM IMMUNOBLOTS

    Separate IgG and IgM immunoblot assays are available containing the CDC recommended specific antigens required for Immunoblot interpretation.

  • ROBUST STRIPS

    Strips are stabilized  with a plastic backing and fixed in a booklet, making them easy to handle.

  • EASILY AUTOMATABLE

    Strips are durable, easy to identify, automatable, with an incubation time of 30/30/10.

  • FAST AND SIMPLE PROCEDURE

    Protocol includes 1:100 serum dilution.

  • INTUITIVE RESULTS

    Easy to read, precisely defined results, with internal test controls (serum and conjugate bands) and kit positive, negative, and cut off controls.

ELISA

  • GSD01-1024: B. burgdorferi lgG/IgM ELISA
  • GSD01-1025: B. burgdorferi lgG ELISA
  • GSD01-1026: B. burgdorferi lgM ELISA
  • GSD01-1027: B. burgdorferi lgG/IgM VlsE-OspC ELISA

Immunoblot

  • GSD01-1022: B. burgdorferi 831 IgG Immunoblot
  • GSD01-1023: B. burgdorferi 831 IgM lmmunoblot

ALL ABOVE REFERENCED PRODUCTS ARE FDA CLEARED

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