NOVA Lite Skin Antibody 708330 - inova

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Determine the fluorescence grade or intensity using these criteria:4+ Brilliant apple green fluorescence3+ Bright apple green fluorescence2+ Clearly distinguishable positive fluorescence1+ Lowest specific fluorescence that enables the intercellular or basement membrane zone areasstaining to be clearly differentiated from the background fluorescenceCalculationsN/AExpected Values & Specific Performance CharacteristicsNOVA Lite TM Skin Antibody substrate was used to test pemphigus and pemphigoid skin disease patients as well as100 random blood donors. The results appear below:Number PositivePatient Group Number Intercellular Basement Membrane ZonePemphigus 24 20 0Pemphigoid 18 0 12Normals 100 0 0Limitations of the Procedure1. The presence of skin autoantibodies is suggestive of certain autoimmune bullous skin diseases but shouldnot be considered diagnostic. The autoantibody result should be considered in combination with otherserological or biopsy results as well as the overall clinical history of the patient.2. In addition to skin autoantibodies, other autoantibodies can react with the esophagus substrate. Some ofthese include anti-nuclear (ANA), anti-mitochondrial (AMA), anti-smooth and anti-skeletal muscleautoantibodies. Presence of these antibodies should be noted and their presence should be confirmed andtitrated on other approved substrates.3. It should be noted that as a sequela to tissue damage, some burn patients produce weakly reactiveantibodies that also bind to intercellular areas. These so-called "pemphigus-like" antibodies give a weak anduneven staining of the mucosa, are transient in nature, and do not react with patient skin in vivo. 13,14,154. Because esophageal mucosa can contain certain blood group substances, anti-A and anti-B blood groupisoantibodies can react with esophagus. 16 The pattern of reactivity can, in some patients, mimic the patternobserved with pemphigus intercellular autoantibodies (although blood group antibody will also stain bloodcapillaries in the musculature of the esophagus section). Reactivity due to blood group antibody can beabsorbed out with blood group antigen. 175. A variety of external factors influence the test sensitivity including the type of fluorescence microscope used,the bulb strength and age, the magnification used, the filter system and the observer.6. If a band pass filter is used instead of a 515 barrier filter, increased artifactual staining may be observed.7. Only pencil should be used to label the slides. Use of any other writing material may cause artifactualstaining.8. All coplin jars used for slide washing should be free from all dye residues. Use of coplin jars containing dyeresidue may cause artifactual staining.9. Results of this assay should be used in conjunction with clinical findings and other serological tests.10. The assay performance characteristics have not been established for matrices other than serum.NCCLS 708330Page 4 of 5
References1. Chorzelski TP, Beutner EH, Jablonska S: "The Role and Nature of Autoimmunity of Pemphigus" inImmunopathology of the Skin, second edition (EH Beutner, TP Chorzelski, SF Bean, eds.) John Wiley andSons, 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 (EHBeutner, 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 andpemphigus 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 thedetermination of pemphigus antibody. Arch. Dermatol. 117:561, 1981.11. Wiik A: Antinuclear factors in sera from healthy blood donors. Acta. Path. Microbiol. Scand. 84:215-220,1976.12. Biosafety in Microbiological and Biomedical Laboratories. Centers for Disease Control and Prevention/NationalInstitutes of Health, Fifth Edition, 200713. Ablin RJ, et.al.: Pemphigus-like antibodies in patients with skinburns. Vox Sang 16:73, 1969.14. Quismorio FP, Bland SL, Friou GJ: Autoimmunity in thermal injury: Occurrence of rheumatoid factors,antinuclear antibodies and antiepithelial antibodies. Clin. Exp. Immunol. 8:701, 1971.15. Trifthauser C, et.al.: Fluorescent antibody studies of pemphigus-like antibodies in burn sera. Ann. NY Acad.Sci. 177:227, 1971.16. Szulman AE: The histological distribution of blood group substances A and B in man. J. Exp. Medicine115:977, 1962.17. Beutner EH, et. al.: "Defined immunofluorescence-Basic concepts and their application to clinicalimmunodermatology." Immunopathology of the Skin, second edition (EH Beutner, TP Chorzelski, SF Bean,eds.) John Wiley and Sons, NY, pp. 29-75, 1979.INOVA Diagnostics, Inc. 858-586-99009900 Old Grove Road 628330 Rev. 16San Diego, CA 921312009/AUGNCCLS 708330Page 5 of 5
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NOVA Lite Skin Antibody 708330 - inova

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