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NOVA Lite™ SA 708330
For In Vitro Diagnostic Use
CLIA Complexity: High

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Intended Use:
NOVA Lite™ SA is an indirect immunofluorescent assay for the screening and semi quantitative determination of skin autoantibodies in human serum. The presence of anti nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of autoimmune skin diseases, especially pemphigus and pemphigoid.

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Overview: Skin Autoantibodies
The term "skin autoantibodies" describes a variety of autoantibodies that react with constituents of skin and mucosal surfaces. These autoantibodies occur with high frequency in patients with autoimmune skin diseases, especially pemphigus and pemphigoid. In virtually all active cases of the bullous skin disease pemphigus, autoantibodies which react with an intercellular antigen of skin and mucosa are found.1 Titers of these autoantibodies are found to parallel the disease activity and decrease with successful therapy.2,3,4

Bullous pemphigoid, another important autoimmune skin disease, is characterized serologically by the presence of antibodies to the basement membrane zone of the skin and mucosa. Circulating antibodies to the basement membrane zone are found in 70 80% of pemphigoid patients.5,6,7 Although there is not such a striking correlation between the disease severity and titer in pemphigoid as there is in pemphigus, there is some degree of relationship. During remission, either spontaneously or after treatment, there is a decrease in the basement membrane zone antibodies, usually to undetectable levels.7 In most cases, relapse is accompanied by the reappearance of basement membrane zone autoantibody.

Indirect immunofluorescence is the most commonly used method to test for skin autoantibodies. Commonly used substrates are either thin sections of rodent or primate skin and mucosa, with primate esophagus sections serving as the substrate of choice.8,9,10 In addition to the substrate type, other factors of vital importance to the correct performance of skin autoantibody tests include: 1) the type of fixative used to prepare the substrate slide and 2) the specificity and fluorescein to protein (F/P) ratio of the FITC-labeled conjugate used. Some fixatives or combinations thereof are known to destroy certain skin antigens and their use should be avoided. The F/P ratio of the conjugate determines the sensitivity and degree of background staining. The specificity of a conjugate is vitally important since the vast majority of autoantibodies are of the IgG subclass. It is known that when autoantibodies are found in healthy people, they are generally of the IgM and IgA subclass and rarely IgG.11 Because of this, conjugates specific for IgG are more disease specific.

Want to learn and understand more about skin autoantibodies? Below is a scientific article explaining in more detail autoantibody binding to the antigen in bullous pemphigoid.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=288138

The following link describes the disease state, symptoms, diagnosis and treatment. Warning: The following article contains graphic pictures!
http://www.aafp.org/afp/20020501/1861.html

  1. Chorzelski TP, Beutner EH, Jablonska S: "The Role and Nature of Autoimmunity of Pemphigus" in Immunopathology of the Skin, second edition (EH Beutner, TP Chorzelski, SF Bean, eds.) John Wiley and Sons, NY, pp. 183 229, 1979.

  2. Chorzelski TP, von Weiss JF, Lever WF: Clinical significance of autoantibodies in pemphigus. Arch. Dermatol.: 93:570, 1966.

  3. Jablonska S, et.al.: Pathogenesis of pemphigus erythematosus. Arch. Dermatol. Res. 258:135, 1977.

  4. Peck SM, et.al.: Studies in Bullous diseases. Arch. Dermatol. 103:141, 1971.

  5. Jordon RE, et.al.: Basement zone antibodies in bullous pemphigoid. JAMA 200:751, 1967.

  6. Person JR, Rogers RS: Bullous and cicatricial pemphigoid. Mayo Clin. Proc. 52:54,1977.

  7. Chorzelski TP, Jablonska S, Beutner EH: "Pemphigoid" in Immunopathology of the Skin, second edition (EH Beutner, TP Chorzelski, SF Bean, eds.) John Wiley and Sons, NY, pp. 243 255, 1979.

  8. Sabolinski ML, et.al.: Substrate specificity of anti ephithelial antibodies of pemphigus vulgaris and pemphigus foliaceous sera in immunofluorescence tests on monkey and guinea pig esophagus sections. J. Invest. Dermatol. 88:545, 1987.

  9. O'Loughlin S, Goldman GC, Provost TT: Fate of pemphigus antibody following successful therapy. Preliminary evaluation of pemphigus antibody determination to regulate therapy. Arch. Dermatol. 114:1769, 1978.

  10. Feibeleman C, Stolzner G, Provost TT: Pemphigus vulgaris. Superiority of monkey esophagus in the determination of pemphigus antibody. Arch. Dermatol. 117:561, 1981.

  11. Wiik A: Antinuclear factors in sera from healthy blood donors. Acta. Path. Microbiol. Scand. 84:215 220, 1976.




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