Antinuclear Antibodies (HEp-2) Kit

  • Applications
    • IF
  • Code # ANK-60
  • Size 60 tests
  • Price Call for Price


Because of the high correlation of positive antinuclear antibodies with SLE a negative ANA essentially rules out this disease. Although antibodies specific to DNA have a high correlation with SLE, antibodies to a number of other nuclear antigens appear to be of diagnostic and/or prognostic significance in diseases such as Progressive Systemic Sclerosis, Mixed Connective Tissue Disease, Sjogren's Syndrome, and Polymyositis, making ANA testing useful not only for SLE, but as a general screening tool for connective tissue diseases.

Among the methodologies available to detect ANA’s are EIA, ELISA, Dot Blot and the Indirect Fluorescent Antibody (IFA) technique. The antigen for the first three methods can either be a spectrum of clinically significant, specific autoantigens, a single mixture of autoantigens from a cell lysate, or a combination of the two. These methods are not as sensitive as IFA, nor can they detect the variety of autoantibodies. They also do not have the pattern recognition quality of the IFA. The IFA test is sensitive, screens for a wide variety of known and unknown autoantibodies and, through pattern recognition, offers insights into the probable identity of the antigen and associated autoimmune disorder. It is the dominant methodology in clinical laboratories at this time and the method of choice for ANA screening and semi-quantitation.

The antigen of the MBL Bion ANA substrate is a human epithelial cell (HEp-2) line established by Moore, Sabachensky and Toolan. HEp-2 cells have been shown to have greater sensitivity than tissue sections and yield sharper pattern recognition. The presence of mitotic figures aids in differential pattern recognition as well as detecting previously unreported nuclear antibodies. Antinuclear antibodies can be found in all major immunoglobulin classes (IgG, IgA or IgM), therefore, antihuman gammaglobulin conjugate that detects all classes is recommended for use in routine ANA testing.

  • Application:
  • Components:
    • ANA (HEp-2) ten Substrate Slides, six wells each (Code# AN-1006)
    • ANA Positive Control Serum (Homogeneous), 0.5 mL (Code# ANP-1040)
    • ANA Negative Control Serum, 0.5 mL (Code# ANN-1010)
    • Conjugate, Immunoglobulin with Counterstain, 3.5 mL (Code# CCP-9970)
    • Mounting Medium, 3.5 mL (Code# MM-9985)
    • PBS Packet, 2 x 1 liter (Code# PBS-9990)


  • Description:

    Antinuclear antibodies (ANA) are a group of autoantibodies characterized by specificity for numerous antigenic determinants of cell nuclei. While the role of ANA’s in the pathogenesis of autoimmune disease is controversial, they are quite useful as disease markers, primarily for diagnostic screening and also to monitor the course of connective tissue diseases.


    The MBL Bion ANA (Anti-Nuclear Antibody) TEST SYSTEM is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The MBL Bion ANA TEST SYSTEM is intended for use as an aid in the diagnosis of certain autoimmune diseases.

  • Product Type:
  • Research Area:
  • Short Description:
    Indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum.
  • Size:
    60 tests
  1. Tan, E., Antinuclear Antibodies: Diagnostic Markers for Autoimmune Diseases and Probes forCell Biology,Adv. Immuno., 44:93-151, 1989.
  2. Nakamura, R., C. Peebles, R. Rubin, et al, Autoantibodies to Nuclear Antigens, 2nd ed., ASCP, Chicago, 1985.
  3. Tan, E., E. Chan, K. Sullivan, et al,Antinuclear Antibodies (ANA’s): Diagnostically Specific Immune Markers and Clues Toward the Understanding of  systemic Autoimmunity, Clin. Immunol. Immunopathol., 47:121-141, 1988.
  4.  Barnett, E.V.,AntinuclearAntibodies and NuclearAntigens, California Medicine, 104:463-469, 1966.
  5. Casals, S.P., G.J. Friou, L.L. Meyers, Significance ofAntibody to DNA in Systemic Lupus Erythematosus, Arth. Rheum., 7:379-390, 1964.
  6. Douvas, A.S., M. Achten, E.M. Tan, Identification of a Nuclear Protein (Scl-70) as a Unique Target of Human Antinuclear Antibodies in Scleroderma, J. Biol. Chem., 244:10514-10522, 1979.
  7.  Moroi, Y., C. Peebles, M.J. Fritzler, et al, Autoantibody to Centromere (Kinetochore) in Scleroderma Sera, Proc. Natl. Acad. Sci., 77:1627-1631, 1980.
  8. Sharp, G.C., W.S. Irwin, E.M. Tan, et al, Mixed Connective Tissue Disease - An Apparently Distinct Rheumatic Disease Syndrome Associated with a specific Antibody to an Extractable Nuclear Antigen (ENA), Am. J. Med., 52:148-159, 1972.
  9. Alsaugh, M.A., W. Talal, E.M. Tan, Differentiation and Characterization ofAutoantibodies and their Antigens in Sjogrens Syndrome, Arth. Rheum., 19:216-222, 1976.
  10. Wolfe, J.F., E.Adelstein, G.C. Sharp,AntinuclearAntibody with Distinct Specificity for Polymyositis, J. Clin. Invest., 59:176-178, 1977.
  11. Nakamura, R.M., C.L. Peebles, D.P. Molden, E.M. Tan, Advances in Laboratory Tests for Autoantibodies to Nuclear Antigens in Systemic Rheumatic Diseases, Lab. Med., 15:190-198, 1984.
  12. Moore, A.E., L. Sabachewsky, H.W. Toolan, Culture Characteristics of Four Permanent Lines of Human Cells, Cancer Res., 15:598-602, 1955.
  13. McCarty, G.A., J.R. Rice, Characterization and Comparison of CommerciallyAvailable Antinuclear Antibody Kits Using Single Pattern Index Sera, J. Rheum., 7:339-347, 1980.
  14. McCarty, G.A., et al, AUnique Antinuclear Antibody Staining Only the Mitotic Spindle Apparatus, New Engl. J. Med., 305:703, 1981.
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  16. Schur, P.H., M. Moore, N. Rothfield, The Subclass of Antinuclear and Antinucleic Acid Antibodies, Arth. Rheum., 15:174-180, 1972. 17. Weller, T.H., A.H. Coons, Fluorescent Antibody Studies with Agents of Varicella and Herpes Zoster Propagated In Vitro, Proc. Soc. Exp. Biol. Med., 86:789-794, 1954.
  17. Weller, T.H., A.H. Coons, Fluorescent Antibody Studies with Agents of Varicella and Herpes Zoster Propagated In Vitro, Proc. Soc. Exp. Biol. Med., 86:789-794, 1954.
  18. Friou, F.J., Clinical Application of Lupus Serum-Nucleoprotein Reaction Using the Fluorescent Antibody Technique, J. Clin. Invest., 36:890, 1957.
  19. Holman, H.R., H.G. Kunkel, Affinity Between the Lupus Erythematosus Serum Factor and Cell Nuclei and Nucleoprotein, Science, 126:162-163, 1957.
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  21. Peter, J.B., R.L. Dawkins, EvaluatingAutoimmune Diseases, Diag. Med., 1-10, Sept/Oct 1979. 
  22. Notman, D.D., N. Kurata, E.M. Tan, Profiles ofAntinuclear Antibodies in Systemic Rheumatic Diseases, Annals Intern. Med., 83:464-469, 1975.
  23. Nakamura, R.M., C.L. Peebles, R.L. Rubin, et al, Autoantibodies to Nuclear Antigens (ANA),ASCP, Chicago, 1985.
  24. Molden, D.P., ANAProfiles in Systemic Rheumatic Disease, Diag. Med., 12-18, June 1985.
  25. Fritzler, M.J., D.W. Valencia, G.A. McCarty, Speckled PatternAntinuclearAntibodies Resembling AnticentromereAntibodies, Arth. Rheum., 27(l):92-96, 1984.
  26. Fritzler, M.J., T.D. Kinsella, E. Garbutt, The CREST Syndrome: A Distinct Serologic Entity with Anticentromere  Antibodies, Am. J. Med., 69:520-526, 1980.
  27. Tan, E.M., G.P. Rodnan, I. Garcia, et al, Diversity of Antinuclear Antibodies in Progressive Systemic Sclerosis, Arth. Rheum., 23:617-625, 1980.
  28. Penning, C., V. Steen, G. Reimer, et al, An Analysis of Systemic Sclerosis Patients with Autoantibodies to the Nucleolar Proteins PM-Scl, RNAPolymerase I and Fibrillarin,A.R.A. Mtg., D29, 1987.
  29. Pinnas, J.L., J.D. Northway, E.M. Tan, Antinucleolar Antibodies in Human Sera, J. Immunol., 111:996-1004, 1973.
  30. Ritchie, R.F.,Antinucleolar Antibodies: Their Frequency and Diagnostic Association, New Engl. J. Med., 282:1174-1178, 1970.
  31. Bianchi, F.B., M. Rizzetto, P. Penfold, et al, Ultrastructural Localization and Characterization of a Ribosomal Antibody Detected by Immunofluorescence in Systemic Lupus Erythematosus, Clin. Exp. Immunol., 17:629-636, 1974.
  32. Rothfield, N.F., Detection ofAntibodies to NuclearAntigens by Immunofluorescence, Manual of Clinical Immunology, ASM, Washington D.C., 85:647-651, 1976.
  33. Pollack, V.E., Antinuclear Antibodies in Families of Patients with Systemic Lupus Erythematosus, New Engl. J. Med., 271:165-171, 1964.
  34. Tan, E.M., M.J. Fritzler, P.A. Reyes-Lopez, Autoantibodies as Biological Markers of Neoplasia: Basic and Applied Aspects, Elsevier-North Holland, New York, 1978.
  35. Cleymaet, J.E., R.M. Nakamura, Indirect Immunofluorescent Antinuclear Antibody Tests: Comparison of Sensitivity and Specificity of Different Substrates, Am. J. Clin. Path., 58:388-393, 1972.
  36. Data on file, MBL Bion, Des Plaines, Illinois.