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.
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.
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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.
Includes antigens from B. burgdorferi strains B31 and 2591.
Contains VIsE immunogenic lipoprotein.
Kit includes ready to use controls for ease of use.
Simple procedure is easy to automate.
Lyme IgG/IgM EIA, IgG EIA, and IgM EIA screens are FDA Cleared and can be easily automated.
Includes antigens from B. burgdorferi strains B31 and 2591.
The 3D (tertiary) antigen structure is maintained, unlike denatured Western blot proteins which only retain primary structure.
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.
Strips are fixed in a booklet with a unique number system.
Strip booklet stabilized with plastic backing.
Protocol includes 1:100 serum dilution with an incubation time of 30/30/10.
Standardized strips are suitable for automation.
The 3D (tertiary) antigen structure is maintained, unlike denatured Western blot proteins which only retain primary structure.
Separate IgG and IgM immunoblot assays are available containing the CDC recommended specific antigens required for Immunoblot interpretation.
Strips are stabilized with a plastic backing and fixed in a booklet, making them easy to handle.
Strips are durable, easy to identify, automatable, with an incubation time of 30/30/10.
Protocol includes 1:100 serum dilution.
Easy to read, precisely defined results, with internal test controls (serum and conjugate bands) and kit positive, negative, and cut off controls.
ALL ABOVE REFERENCED PRODUCTS ARE FDA CLEARED
Lyme Diagnostics BrochureGSDM-0112 Brochure