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SmartEIA Borrelia b. sensu stricto IgM

SmartEIA Borrelia b. sensu stricto IgM
EAN Code: 8595635305689
Catalog number: SK-BsM096
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 of Borrelia b. sensu stricto infection using IgM antibodies in human serum, plasma, cerebrospinal fluid or synovial fluid in the general population. The semi-quantitative semi-automated assay is designed for professional use in a laboratory.

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Description

Description:

·         Microtitre wells are coated with the sonicated whole-cell antigen of Borrelia burgdorferi sensu stricto rich in p83, p41 (flagelin), p39, OspA, OspB, OspC, p28 a p21.

·         If present, specific antibodies bind to the antigen. The complex is labelled with Conjugate and detected through a colour reaction with substrate (TMB-Complete).

·         The kit enables 96 tests (including controls) within the microtitre plate made of colour-coded strips and breakable wells.

·         Total assay time: approximately 1.5 h.

·         High sensitivity and specificity.

·         Controls, Conjugate and substrate (TMB-Complete) are supplied in working strength.

·         Sample diluent, TMB-Complete and Avidity Solution are interchangeable if provided with identical numeric marking (i.e. Sample Diluent 2, Sample Diluent 3, etc.).  Stop Solution and Wash Solution are interchangeable in all TestLine kits.

·         CUT-OFF included.

·         Colour reagents for easy pipetting.

·         Semiquantitative evaluation using the index of positivity (IP).

Applications:

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

·         Checking of therapy results using the semiquantitative determination.

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 for 30 min at 37 °C.

4.       Aspirate and wash the wells 4 times.

5.       Add Conjugate.

6.       Incubate for 30 min at 37 °C.

7.       Aspirate and wash the wells 5 times.

8.       Add substrate (TMB-Complete).

9.       Incubate for 15 min at 37 °C.

10.   Add Stopping solution (H2SO4).

11.   Read photometrically at 450 nm.

12.   Evaluate results.

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

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