Intended use:

For in vitro diagnostics. The RIDASCREEN® Borrelia tests (K3221, K3231) are enzyme immunoassays for the quantitative determination of IgG or IgM antibodies against Borrelia burgdorferi sensu lato in human serum. The tests should be used for confirmation purposes when there is a suspected case of borreliosis or for clarifying the immune status.

General information:

The clinical course of a borreliosis can be divided into three stages. These stages can turn into each other, but they can also be separated by periods of a symptom-free latency. The course of the disease is not obligate. Symptoms generally found in specific stages can be missed and spontaneous recovery may occur at any point. Standard tests for specific antibody detection (IFA, ELISA, Western Blot) have been established as laboratory tests, since cultural growth of the organism from skin samples and blood is very difficult. But serological diagnostic is difficult, since antibodies are not detectable in 50 – 60% of the patients with clinical manifestations in stage 1 as well as 10 – 30% in stage 2. In stage 3 of the disease high antibody titers can be detected generally. Furthermore, it has to be considered that an early antibiotic therapy can prevent the occurrence of serious and chronic disease manifestations. But, it reduces also the production of antibodies.

Test principle:

Purified antigens are coated to a microwell plate. Antibodies in the patient samples bind to the antigens and are determined during the second incubation step by using enzyme-labelled anti-human antibodies (the conjugate). The enzyme converts the colourless substrate (H2O2/TMB) to a blue end product. The enzyme reaction is stopped by adding sulphuric acid and the colour of the mixture switches from blue to yellow at the same time. The final measurement is carried out at 450 nm on a photometer using a reference wavelength ≥ 620 nm.

Please also pay attention to our Microspot array (Art. No. SP-006-10 G-S6 (1×48), SP-006-10 M-S6 (1×48), SP-006-10 G-S12 (1×96), SP-006-10 M-S12 (1×96), SP-006-10 G- S24 (2×96), SP-006-10 M- S24 (2×96)) for detailed antibody detection against Borrelia IgG or IgM.

Art. No. K32**
Test format Article no. K3221
Borrelia IgG (96 determinations)

Article no. K3231
Borrelia IgM (96 determinations)

Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)

Incubation time 3 x 30 min at 37 ºC
Sensitivity 100.0% (IgG)
100.0% (IgM)
Specificity 97.4% (IgG)
93.6% (IgM)
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