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SmartEIA Borrelia recombinant IgG

SmartEIA Borrelia recombinant IgG
EAN Code: 8595635305702
Catalog number: SK-BrG096
Package size: 96 tests
Regulatory status: IVD CE
Storage: 2-8 °C
Producer: TestLine Clinical Diagnostics s.r.o.

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Contact person:

Name: MUDr. Jana Dočkalová
Phone: +420 549 121 205
E-mail: trade@testlinecd.com

The immunoenzymatic assay is intended for the diagnosis and monitoring of Borrelia burgdorferi infection using IgG antibodies in human serum, plasma, cerebrospinal fluid or synovial fluid in the general population. The semi-quantitative and quantitative semi-automated assay is designed for professional use in a laboratory.

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Description

Description:

·         Microtitre wells are coated with a combination of selected parts of the specific antigens of Borrelia burgdorferi sensu lato (VlsE, internal flagellin - p41i and p17).

·         III. generation kit; high sensitivity and specificity of the test.

·         If specific antibodies are present, they bind to the antigen, are labeled by the Conjugate in the following steps and are detected by color reaction with a single component substrate (TMB-Complete).

·         The kit allows 96 tests, including controls in a split microtiter plate with color-coded strips and breakable wells.

Advantages:

·         The total assay time is about 1 hour 30 minutes.

·         High sensitivity and specificity of the test.

·         Kit includes CUT-OFF, Positive Control, Negative Control and Calibrators.

·         Semi-quantitative evaluation in the Index of Positivity (IP) or quantitative evaluation in U/ml units.

·         Ready-to-use, color-coded components.

·         Single-component substrate.

·         Interchangeable components with the exception of kit specific components (Controls, Conjugate, Plate).

·         Detection of intrathecal production of specific antibodies with the Antibody Index Software (made by TestLine).

Application:

·         Screening test for the detection of Lyme borreliosis in humans.

·         High dynamics of antibody response, specification of disease stage.

·         Improvement in diagnostic of neuroborreliosis by the detection of intrathecal production of specific antibodies to Borrelia sp.

Brief assay procedure:

1.       Dilute samples of serum/plasma (1:101), synovial fluid (1:21, 1:41) or cerebrospinal fluid (1:2).

2.       Pipette Controls and diluted Samples.

3.       Incubate at 37°C for 30 min.

4.       Aspirate and wash the wells 5×

5.       Pipette Conjugate.

6.       Incubate at 37°C for 30 min.

7.       Aspirate and wash the wells 5×

8.       Pipette Substrate (TMB-Complete).

9.       Incubate at 37°C for 15 min.

10.   Pipette Stop Solution.

11.   Read color intensity at 450 nm.

12.   Evaluate the test.

SmartEIA kits are specifically designed for automated processing on the Agility® instrument, Dynex Technologies, Inc.

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