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MRL Diagnostics' HSV-1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the MRL HSV-2 ELISA IgG, the test is indicated for 1) testing sexually active adults, with or without a clinical history of herpes, for aiding in the presumptive diagnosis of HSV infection to identify persons who are at risk for transmitting or acquiring HSV so they may be counseled, and 2) testing expectant mothers for aiding in the presumptive assessment of the risk for acquiring and/or transmitting HSV to their child, so they may be counseled.

In the MRL Diagnostics HSV-1 ELISA IgG assay, the polystyrene microwells are coated with recombinant gG-1 antigen. Diluted serum samples and controls are incubated in the wells to allow specific antibody present in the samples to react with the antigen. Nonspecific reactants are removed by washing, and peroxidase-conjugated anti-human IgG is added and reacts with specific IgG. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD) which is directly proportional to the amount of antigenspecific IgG present in the sample. Sample optical density readings are compared with reference cut-off OD readings to determine results.

MRL Diagnostics' HSV-2 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. In conjunction with the MRL HSV-1 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment.

In the MRL Diagnostics HSV-2 ELISA IgG assay, the polystyrene microwells are coated with recombinant gG-2 antigen. Diluted serum samples and controls are incubated in the wells to allow specific antibody present in the samples to react with the antigen. Nonspecific reactants are removed by washing, and peroxidase-conjugated anti-human IgG is added and reacts with specific IgG. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD). Sample optical density readings are compared with reference cut-off OD readings to determine results.

MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup 1 (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis of Lyme disease, using serum samples which have been found positive or equivocal by a B. burgdorferi screening method (e.g., IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG can be used at any time following onset of symptoms provided the IFA or ELISA is positive or equivocal. Also, it should be used for follow up when: 1) only IgM antibodies were originally detected, 2) IgG antibodies were detected, but were not considered significant by Western blot, or 3) previously seronegative patients subsequently test positive by IFA or ELISA.

MRL Diagnostics separates B. burgdorferi proteins by polyacrylamide gel electrophoresis and electrophoretically transfers the fractionated proteins from the gel to a nitrocellulose membrane. The nitrocellulose membrane is dried and cut into strips. The antigen strips are numbered and packaged. The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is a two stage procedure. In the first stage, the patient sera is diluted and incubated with individual antigen strips. If antibodies to B. burgdorferi are present in the sera, they will bind to the Borrelia antigens immobilized on the nitrocellulose membranes. In the second stage, visualization of the bound antibodies is accomplished by incubating the blots with alkaline phosphatase-conjugated goat anti-human IgG, (Fc fragment specific) followed by the addition of substrate (BCIP/NBT) which forms a colored precipitate at each site (antigen band) where the anti-human conjugate has bound. The resulting pattern of band reactivity is then interpreted.

MRL Diagnostics' Lyme Disease Borrelia burgdorferi Genogroup 1 Western Blot IgM test allows the qualitative detection of IgM class antibody in human serum to individual proteins of the genogroup 1 (B. burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot assay is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, using serum samples which have been found positive or equivocal by another B. burgdorferi detection methodology (e.g. IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected patients are usually found to be Western Blot positive for IgG. For persons beyond the acute phase, a positive IgM test alone is not recommended for determining active disease in patients. Therefore, both IgG and IgM Western Blots should be used after the acute phase.

MRL Diagnostics separates B. burgdorferi proteins by polyacrylamide gel electrophoresis and electrophoretically transfers the fractionated proteins from the gel to a nitrocellulose membrane. The nitrocellulose membrane is dried and cut into strips. The antigen strips are numbered and packaged. The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM test is a two stage procedure. In the first stage, the patient sera is diluted and incubated with individual antigen strips. If antibodies to B. burgdorferi are present in the sera, they will bind to the Borrelia antigens immobilized on the nitrocellulose membranes. In the second stage, visualization of the bound antibodies is accomplished by incubating the blots with alkaline phosphatase-conjugated goat anti-human IgM, (Fc fragment specific) followed by the addition of substrate (BCIP/NBT) which forms a colored precipitate at each site (antigen band) where the anti-human conjugate has bound. The resulting pattern of band reactivity is then interpreted.