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TABLE OF CONTENTS
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SLIDE ASSAYS ANA - Antinuclear Antibody Assay ANCA (anti-neutrophil cytoplasmic antibodies) ELISA ASSAYS RELISA ENA Single Well Screening Kit RELISA Cardiolipin Antibody Screening Kit RELISA Cardiolipin IgG & IgM Antibody Kit RELISA MPO and PR3 Antibody Test Kits IMMUNODIFFUSION ASSAYS EDUCATIONAL / TECH SUPPORT / QUALITY CONTROL |
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Immuno Concepts manufactures slides that are compatible with multichannel pipettors, which allows the technologist to decrease the number of pipetting steps required to prepare and place the patient sample dilutions on the slides. Ask Immuno Concepts for more information about this procedure and these slides. These slide formats are noted with an * after the catalog number and are available in both fluorescent and Colorzyme test kits. For ease of use, Immuno Concepts ANA test kits feature ready-to-use conjugates and controls, and come with... • Substrate slides • Positive pattern controls • Titratable control referenced to the WHO standard • Negative control • Conjugate • PBS • Mounting medium A number of different kit and slide formats are available in addition to those listed in the catalog. Please ask Immuno Concepts or your local representative for these other options. |
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HEp-2000 ANA uses a patented HEp-2 cell line that has been genetically engineered to increase the sensitivity to SS-A/Ro autoantibodies, without affecting the other ANA patterns seen. Several independent studies have been published worldwide on the HEp-2000 ANA substrate, which show increased sensitivity to SS-A/Ro autoantibodies when used in place of standard HEp-2 cells as the routine ANA screening test. (1, 2, 3, 4) • Genetically engineered HEp-2 cells hyperexpress the native 60kD SS-A/Ro antigen • Differentiation of positive SS-A/Ro samples by the distinctive staining pattern • Increased concentration of SS-A/Ro antigen detects more SS-A/Ro positive samples (1) • Considered as confirmatory for SS-A/Ro autoantibodies when the distinctive hyperexpressing pattern is seen • HEp-2000 cells exhibit the same ANA patterns for all of the other antibody specificities as HEp-2 cells 1. Fritzler M. J., Miller B. J. Detection of Autoantibodies to SS-A/Ro by Indirect Immunofluorescence Using a Transfected and Overexpressed Human 60 kD RoAutoantigen in HEp-2 Cells. J. Clin. Lab. Anal. 9:218-224, 1995. 2. Keech C. L., Howarth S., Coates T., Rischmueller M., McCluskey J., Gordon T. P. Rapid and Sensitive Detection of Anti-Ro (SS-A) Antibodies by Indirect Immunofluorescence of 60kDa Ro HEp-2 Transfectants. Pathology 28:54-57, 1996. 3. Keech C. L., McCluskey J., Gordon T. P. Transfection and Overexpression of the Human 60-kDa Ro/SS-A Autoantigen in HEp-2 Cells. Clin. Immunol. Immunopathol. 73:146-151, 1994. 4. Pollock, W. and Toh, B.H. Routine immunofluorescence detection of Ro/SS-A autoantibody using HEp-2 cells transfected with human 60 kDa Ro/SS-A. J.Clin.Pathol. 52:684-687, 1999. |
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HEp-2000 ANA uses a patented HEp-2 cell line that has been genetically engineered to increase the sensitivity to SS-A/Ro autoantibodies, without affecting the other ANA patterns seen. Several independent studies have been published worldwide on the HEp-2000 ANA substrate, which show increased sensitivity to SS-A/Ro autoantibodies when used in place of standard HEp-2 cells as the routine ANA screening test. (1, 2, 3, 4) • Enhanced detection of SS-A/Ro autoantibodies • Includes a positive SS-A/Ro control as recommended in NCCLS document I/LA2-A, i/Quality Assurance for the Indirect Immunofluorescence Test for Autoantibodies to Nuclear Antigen (IF-ANA). Approved Guideline lA. • Abundant easy-to-read mitotic cells • Clear pattern identification • Ready-to-use pattern controls and conjugates • Positive pattern controls for: - homogeneous - centromere - SS-A/Ro - speckled - nucleolar • Titratable control referenced to the WHO standard 66/233 for ANA
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Colorzyme HEp-2000 ANA
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HEp-2000 ANA uses a patented HEp-2 cell line that has been genetically engineered to increase the sensitivity to SS-A/Ro autoantibodies, without affecting the other ANA patterns seen. Several independent studies have been published worldwide on the HEp-2000 ANA substrate, which show increased sensitivity to SS-A/Ro autoantibodies when used in place of standard HEp-2 cells as the routine ANA screening test. (1, 2, 3, 4) Colorzyme HEp-2000 uses a patented color reagent system that eliminates the variability seen with fluorescent methods such as type of light source, filters and extraneous room light. • Enhanced detection of SS-A/Ro autoantibodies • An immunoenzyme technique using a patented color reagent system • Results can be read on a standard light microscope • Stable color reaction allows for storage of slides for later review • Uses the same HEp-2000 substrate as our fluorescent test system • Easy to read sharp clear patterns
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Immuno Concepts manufactures slides that are compatible with multichannel pipettors, which allows the technologist to decrease the number of pipetting steps required to prepare and place the patient sample dilutions on the slides. Ask Immuno Concepts for more information about this procedure and these slides. These slide formats are noted with an * after the catalog number and are available in both fluorescent and Colorzyme test kits. These test systems incorporate many of the same features as the HEp-2000 test kits such as... • Abundant easy-to-read mitotic cells • Clear pattern identification • Ready-to-use pattern controls and conjugates • Substrate slides • Positive pattern controls for: homogeneous, centromere, speckled, nucleolar • Titratable control referenced to the WHO standard 66/233 for ANA • Negative control • Conjugate • PBS • Mounting medium
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Immuno Concepts manufactures slides that are compatible with multichannel pipettors, which allows the technologist to decrease the number of pipetting steps required to prepare and place the patient sample dilutions on the slides. Ask Immuno Concepts for more information about this procedure and these slides. These slide formats are noted with an * after the catalog number and are available in both fluorescent and Colorzyme test kits. Colorzyme HEp-2 ANA uses a patented color reagent system that eliminates the variability seen with fluorescent methods such as type of light source, filters and extraneous room light. • An immunoenzyme technique using a patented color reagent system • Results can be read on a standard light microscope • Stable color reaction allows for storage of slides for later review • Uses the same HEp-2 substrate as our fluorescent test system • Easy to read sharp clear patterns
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nDNA antibodies show a high correlation with active systemic lupus erythematosus (SLE). Slide tests featuring the Crithidia luciliae substrate continue to be the most widely used assay for anti-DNA autoantibody testing worldwide. • Similar procedure as Immuno Concepts ANA assay • Easy-to-read results • Features ready-to-use conjugates and controls, and comes with... • Substrate slides • Conjugate • Titratable control • Positive and negative controls • PBS • Mounting medium |
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nDNA antibodies show a high correlation with active systemic lupus erythematosus (SLE). Slide tests featuring the Crithidia luciliae substrate continue to be the most widely used assay for anti-DNA autoantibody testing worldwide. There are several different options available for the fluorescent DNA test system.
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nDNA antibodies show a high correlation with active systemic lupus erythematosus (SLE). Slide tests featuring the Crithidia luciliae substrate continue to be the most widely used assay for anti-DNA autoantibody testing worldwide. Colorzyme DNA uses a patented color reagent system that eliminates the variability seen with fluorescent methods such as type of light source, filters and extraneous room light. There are several different options available for the Colorzyme DNA test system.
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ANCA are associated with vasculitic diseases including Wegener's granulomatosis and microscopic polyangiitis as well as diseases such as inflammatory bowel disease. The immunofluorescent technique using human neutrophils is widely accepted as the best method of screening for ANCA. The Immuno Concepts kits include... • Designated control wells on each slide to assist with quality control • Substrate slides • Conjugate • Positive controls for P-ANCA & C-ANCA • Mounting medium • Titratable controls for P-ANCA & C-ANCA • Sample diluent • Negative control • PBS
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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 65 minutes • Same 1:40 dilution can be used for the IFA test • Test strips are individually pouched to provide kit stability
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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 65 minutes • Test strips are individually pouched to provide kit stability Test system comes with... • Antigen coated microtiter wells • Positive and negative controls • Sample diluent • PBS • Conjugate • Substrate solution • Stopping reagent |
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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.
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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.
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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
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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.
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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.
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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 over looked. 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 65 minutes • Test strips are individually pouched to provide kit stability 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
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AUTO I.D. ENA Test Kits offer a cost effective method for identification of patient autoantibodies to seven different ENAs. All of the optional controls can be used with any of the Auto I.D. Test Kits, which come complete with... • universal antigen (contains Sm, RNP, SS-A, SS-B, Scl-70, PCNA & Jo-1 autoantigen) • agarose plates • positive controls • worksheets
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Education Since its inception, Immuno Concepts has made a dedicated effort to promote education in our field. In support of this commitment we have funded research projects, donated product to schools and developed training aids for clinicians and laboratorians. Each year, through our seminars and PSITS programs, hundreds of technologists and clinicians are enlightened to the significant contribution that ANA and related testing can have on the diagnosis of the patient. Seminars Each year Immuno Concepts conducts educational seminars in various locations worldwide. The seminars primarily focus on autoantibodies seen in the systemic rheumatic diseases, but also include current information on topics such as ANCA related vasculitis and anti-phospholipid syndrome. These seminars are continuously updated with current information from scientific journals. In the United States and selected foreign countries the seminars are certified for Continuing Education Credits (CEU). Ask Immuno Concepts or your local representative for information on the next workshop nearest you. Visions Training Program Maintaining a well-trained staff is essential. The Visions training program is a self-taught, on-site training program for ANA's. These programs, now available on CD-ROM, cover basic to advanced information on ANA methodology, patterns, follow-up testing, and troubleshooting. The CD-ROM version includes two quizzes on ANA patterns. Each series, II and III, consists of sixty (60) 35 mm slides or color plates and accompanying text. Visions II focuses on basic ANA methodology, patterns and follow-up testing, while Visions III looks at HEp-2000, ANA titering, troubleshooting, ANCA, and cytoplasmic patterns. Visions III is most effective when used in conjunction with Visions II. The CD-ROM combines both series together in a user-friendly format.
Technical Support Although we are not a licensed reference laboratory, we are happy to offer this full support free of charge to our customers. Simply call Technical Support at (800) 251-5115; (916) 363-2649, or e-mail us at techservice@immunoconcepts.com. Immuno Concepts commitment to quality continues after the sale with our comprehensive Technical Support. Our trained professionals are ready to answer your questions on testing procedures, troubleshooting techniques, interpretation of results, or other topics related to our products or Autoimmune diseases in general. Because we maintain an extensive library of current references, and have working relationships with recognized experts in the field, we are able to offer our customers support that is up to date with current research. One of the long-standing features of our Technical Support has been assisting with pattern interpretation. Laboratories from around the world often send unusual samples for consultation on pattern identification and clinical significance. Now, by combining the power of the internet with our in-house digital optics, we are able to test the samples and e-mail photos of the patterns along with our comments back to our customers. This gives the customer a record of how the pattern appeared and tips on identification of the pattern in the future. Patient Sample Interpretive Training Series (PSITS) This program is a valuable on-going training tool for the laboratory. Every three months a patient sample and history are sent to each participating laboratory. Based upon the ANA test results, each laboratory determines which follow-up tests to perform on the sample. Returned results are compiled and each participating laboratory is sent: • A summary report including the expected results • A comparison to other methods and laboratories • A summary of the clinical diagnosis of the patient based upon the laboratory results
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FITC-QC Slide The FITC-QC Slide is an independent quality control check for assessing the level of fluorescent intensity provided by each laboratory's microscope. Each slide has five different wells of microbeads containing FITC, ranging from 4+ to +/- in intensity. The concentration of FITC in the microbeads is calibrated by flow cytometry. The FITC-QC Slide allows the laboratory to verify proper performance of the optical system of their fluorescent microscope before beginning each run. This conforms to the NCCLS-approved guidelines as outlined in document I/LA2-A.
Optional Controls Immuno Concepts has always realized that correct pattern recognition is critical for accurate reporting of ANA results. This is why many of our standard ANA kits include four positive ANA controls (homogeneous, speckled, centromere and nucleolar). To augment these more common patterns, we offer a variety of optional controls to assist with pattern recognition. These optional controls come pre-diluted in ready-to-use dropper vials.
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