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Lyme IgM

Technology : Western Blot ~ Infectious Disease

Brand : MarDx® ~ Infectious Disease

Analyte : Infectious Diseases ~ Lyme

Intended Use

MarDx B. burgdorferi (IgM) Marblot Strip Test System is a Western blot assay for the qualitative in vitro detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum. The MarDx B. burgdorferi (IgM) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.
The MarDx B. burgdorferi (IgM) Marblot Strip Test System can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. Patients initially infected with B. burgdorferi are commonly found to have a positive IgM blot and a negative IgG blot, indicative of an acute disease stage. After this early period, infected patients are usually found to be Western blot positive IgG, confirming seroconversion.
Caution must be used in supporting a diagnosis of B. burgdorferi infection when sera are Western blot IgM positive and Western blot IgG negative after the initial 4 week period from onset. Because the likelihood of a false-positive test result is high for these individuals, a positive IgM test alone is not recommended for use
in determining active disease in persons with illness of longer than one month duration. If symptoms persist, the patient should be retested for seroconversion to IgG antibodies after an additional 2 to 4 weeks.

Principle

The MarDx B. burgdorferi (IgM) Marblot Strip Test System is a Western blot technique utilizing antigens of B. burgdorferi (Strain B 31) which are separated in the presence of sodium dodecyl sulfate (SDS) by polyacrylamide gel electrophoresis. The resolved protein bands are then transferred by electrophoresis to a nitrocellulose membrane. The membrane is dried, cut into strips, and packaged.
Serum is incubated with individual Marblot B. burgdorferi strips. If specific antibodies to individual proteins are present, they will bind to the corresponding B. burgdorderi antigen bands. After washing the unbound serum from the strip, the bound B. burgdorferi specific antibody is reacted with alkaline phosphatase conjugated anti-human IgM. The strip is then washed to remove the unbound conjugated antibody, and the strip is finally reacted with a precipitating color
developing solution which deposits a purple precipitate on antibody reacted antigen bands. Bands are visualized, scored for intensity relative to the 41kDa band of the Weakly Reactive Control and recorded. Strips which have 2 of the 3 significant bands are considered positive for specific IgM antibody to B. burgdorferi.

Product Code : 40-2065M/B

Format : MarBlot ™ 400 T

Test/Kit : 400 tests

FDA : Cleared

CE : Cleared

Additional Information :
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Package Inserts
Lyme IgM (400) (English)
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