RELISA® ELISA Assays

RELISA® ANA Screening System

For laboratories that have decided to change to the ELISA methodology for their ANA screens, we believe the RELISA® ANAs correlation with IFA and many user friendly features provide an advantage over the competition. While no ELISA ANA currently on the market is capable of 100% correlation with IFA, our RELISA® ANA screen has been shown to be quite effective at detecting clinically significant autoantibodies to nuclear antigens including: Sm/RNP, SS-A/Ro, SS-B/La, dsDNA, Scl-70, and others. These are autoantibodies often seen in patients with SLE or other systemic rheumatic diseases.

• Easily automated

• Test strips are color coded and feature break-away wells

• Liquid stable ready-to-use conjugates

• Liquid stable ready-to-use controls

• Total assay time of 90 minutes

• Same 1:40 dilution can be used for the IFA test

Ordering Information:
7096-11 96 wells per kit
7696-11 576 wells per kit

Other kit configurations are available upon request.

For a copy of the package insert, please click on the appropriate link below.

RELISA® ANA Screening Test System
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RELISA® DNA

Patients with systemic lupus erythematosus (SLE) may produce antibodies to a variety of nuclear antigens, but antibodies directed against Sm (Smith antigen) and double stranded DNA (dsDNA) show the highest correlation with disease (1). Antibodies directed against Sm demonstrate a speckled ANA staining pattern while antibodies directed against dsDNA generally demonstrate a homogeneous ANA staining pattern. Although low levels of anti-dsDNA antibodies may be present in the serum of patients with rheumatoid arthritis, Sjögren’s syndrome, progressive systemic sclerosis, dermatomyositis, discoid lupus erythematosus, and mixed connective tissue disease (2), high levels of dsDNA antibodies are seen almost exclusively in SLE. Antibodies against dsDNA are thought to be involved in the pathogenesis of the most severe variants of SLE when deposited as immune complexes (3). Antibodies to dsDNA occur in high titer, and, because they correlate with disease activity (4), their detection is important in the management of SLE patients.

Several assays are available for the detection of anti-dsDNA antibodies. The most commonly used methods include indirect immunofluorescence, radioimmunoassay, counterimmunoelectrophoresis, and immunodiffusion (5-8). The Immuno Concepts RELISA® anti-dsDNA test system is an enzyme immunoassay (EIA) method that detects serum antibodies to dsDNA.

• Total assay time of 90 minutes

Test system comes with:

• Antigen coated microtiter wells

• Positive and negative controls

• Sample diluent

• PBS

• Conjugate

• Substrate solution

• Stopping reagent

Ordering information:

7096-17 RELISA® dsDNA Test System 96 wells

*Available outside the USA only

RELISA® DNA Test System
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RELISA® ENA (extractable nuclear antigens)

The RELISA® ENA assays were designed with the proper sensitivity and specificity to help the clinician in the diagnosis of autoimmune disease. Sera from over 2,000 patients with rheumatic disease and 1,000 normal individuals were tested during the development of the RELISA® ENA Test System. Immuno Concepts compared the results to reference methods such as Ouchterlony immunodiffusion, counterimmunoelectrophoresis, other ELISA methods and Western blotting. To verify the clinical utility of the assay, the laboratory results were also compared to the clinical history and diagnosis of the patient.

• Affinity purified native mammalian antigens

• Specificity and sensitivity are designed to provide diagnostically meaningful results

• Liquid stable ready-to-use controls and conjugates

• Total assay time of 90 minutes

Test system comes with…

• Antigen coated microtiter wells

• Positive and negative controls

• Sample diluent

• PBS

• Conjugate

• Substrate solution

• Stopping reagent

 

RELISA® ENA Single Well Screening Kit

The RELISA® ENA Single Well Screening Kit is designed to screen patient samples for six of the most common autoantibodies. Each microtiter well is coated with Sm, RNP, SS-A, SS-B, Scl-70 and Jo-1 autoantigens. This allows the laboratory to cost effectively screen out the ENA negative patient samples prior to determining the ENA specificity on any of the company’s other RELISA® ENA Test Systems. The strips are color-coded for easy identification and feature break-away wells.

Ordering Information:
7096-10 96 wells per kit
7696-10 576 wells per kit

Other kit configurations are available upon request.

For a copy of the package insert, please click on the appropriate link below.

RELISA® ENA Single Well Screening Test
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RELISA® ENA Multiparameter Kit

The RELISA® ENA Multiparameter Kit is designed for testing patient samples for six of the most common autoantibodies. This kit features a unique quality control system. The built-in RPC (RELISA® Procedure Check) well in each strip gives the laboratory maximum flexibility in determining their quality control procedures.

Ordering Information:
7096-09 96 wells per kit
7696-09 576 wells per kit

Other kit configurations are available upon request.

For a copy of the package insert, please click on the appropriate link below.

RELISA® ENA Multiparameter Antibody Screening Test
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Cardiolipin

Immuno Concepts RELISA® Cardiolipin Test Kits provide maximum flexibility for anti-cardiolipin testing by offering both a screening kit using a polyvalent conjugate and an isotype specific test kit. Test kits feature ready-to-use reagents and controls, and come complete with…

• Test strips feature break-away wells and are pouched to provide kit stability

• Positive and negative controls

• Single point calibration

• Sample diluent

• PBS

• Liquid stable ready-to-use conjugate

• Substrate solution

• Stopping reagent

RELISA® Cardiolipin Screening Kit

The RELISA® Cardiolipin screening kit is designed to screen patient samples for IgG, IgM and IgA anti-cardiolipin antibodies using a polyvalent conjugate. This kit allows the laboratory to cost effectively screen out anti-cardiolipin negative patient samples prior to determining the antibody specificity using Immuno Concepts RELISA® Cardiolipin IgG & IgM test kit.

Ordering Information:
7096-01 IgG, IgM & IgA Screen 96 wells per kit
7696-01 IgG, IgM & IgA Screen 576 wells per kit

Other kit configurations are available upon request.

For a copy of the package insert, please click on the appropriate link below.

RELISA® Cardiolipin Antibody Screening Test
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RELISA® Cardiolipin IgG & IgM Antibody Test Kit

This isotype specific RELISA® Cardiolipin Kit is designed to determine the individual concentrations of IgG and IgM anti-cardiolipin antibodies in patient samples. The kit includes isotype specific conjugate, calibrators and controls.

Ordering Information:
7096-02 IgG & IgM 96 wells per kit
7696-02 IgG & IgM Screen 576 wells per kit

Other kit configurations are available upon request.

For a copy of the package insert, please click on the appropriate link below.

RELISA® Cardiolipin IgG & IgM Antibody Test
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RELISA® MPO and PR3 Antibody Test Kits

Autoantibodies to MPO-ANCA and PR3-ANCA have been shown to be associated with pauci-immune crescentic glomerulonephritis and Wegener’s granulomatosis respectively. Using ethanol fixed neutrophils in an indirect immunofluorescence assay (IIF), autoantibodies to MPO-ANCA most often produce a perinuclear or P-ANCA staining pattern and autoantibodies to PR3-ANCA produce a cytoplasmic or C-ANCA pattern. However, IIF patterns alone are not confirmatory for MPO- or PR3-ANCA. Our RELISA® MPO and PR3 Antibody Test Kits are a convenient method for confirmation of MPO- or PR3-ANCA autoantibodies. The importance of detecting and confirming these autoantibodies cannot be overlooked. The International Group for Consensus on Testing and Reporting of Antineutrophil Cytoplasmic Antibodies (ANCA) has recommended as a minimum that both indirect immunofluorescence (IIF) and confirmatory ELISA testing be done on all samples. It has been shown that about 10% of ANCA positive sera are only detected by IIF and about 5% are positive only by ELISA (1). And, in a separate publication, an independent study reported combining (IIF) patterns with an ELISA assay such as the Immuno Concepts RELISA® MPO- and PR3-ANCA can improve the diagnostic specificity of ANCA testing to 99% (2). In addition to the diagnostic value of identifying which ANCA antibodies are present, monitoring the level of PR3- and MPO-ANCA antibodies can be useful. These antibody levels usually correlate with disease activity in patients with Wegener’s granulomatosis, microscopic polyangiitis, and pauci-immune segmental necrotizing glomerulonephritis. (1)

• Test strips are color coded and feature break-away wells

• Easily automated

• Purified native human antigens

• Liquid stable ready-to-use controls and conjugates

• Kit contains reagents and procedures for both single point qualitative and multi-point semi-quantitative assays

• Total assay time of 75 minutes

1. Savige, J., Gillis, D., Benson, E., Davies, D., Esnault, V., Falk, R.J., Hagen, E.C., Jayne, D., Jennette, J.C., Paspaliaris, B., Pollock, W., Pusey, C., Savage, C.O.S., Silvestrini, R., Van der Woude, F., Wieslander, J., Wiik, A. International consensus statement on testing and reporting of antineutrophil cytoplasmic antibodies (ANCA). Am.J.Clin.Pathol. 111:507-513, 1999.

2. Hagen EC, Daha MR, Hermans J, et al. EC BCR Project ANCAAssay Standardization: Diagnostic value of standardized assays for anti-neu- trophil cytoplasmic antibodies in idiopathic systemic vasculitis. Kidney Int 53:743-753, 1998

Ordering Information:
7096-15 RELISA MPO-ANCA Test System 96 wells/kit
7096-16 RELISA PR3-ANCA Test System 96 wells/kit

Other kit configurations are available upon request.

For a copy of the package insert, please click on the appropriate link below.

RELISA® MPO Test System
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RELISA® PR3 Test System
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