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Collagen Vasculitic Disorders

Connective Tissue Disorders

Anti-Nuclear Antibodies (ANA)

Anti-Nuclear Antibodies (ANA) Blot

DNA Antibodies

Histone Antibodies

Extractable Nuclear Antigen (ENA) autoantibodies

Ribosomal P/RNA Antibodies

Rheumatoid Arthritis Disorders

Rheumatoid Factor (RF)

Keratin Antibodies

Vasculitis Disorders

Phospholipid/Cardiolipin Antibodies (APL)

Anti-Neutrophil Cytoplasmic Antibodies (ANCA)

Glomerular Basement Membrane (GBM) Antibodies

Gastrointestinal Disorders

Autoimmunity may effect many varied systems in the body. A number of gastrointestinal diseases are autoimmune in nature, including Celiac Disease and Inflammatory Bowel Disorders. Prompt and accurate diagnosis of these conditions is essential. Laboratory diagnostics are available to support diagnosis.

Celiac Diseases

Endomysial Antibodies (EMA)

Reticulin Antibodies (ARA)

Tissue Transglutaminase (tTG) Antibodies

Gliadin Antibodies (AGA)

Inflammatory Bowel Diseases

Anti-Neutrophil Cytoplasmic Antibodies (ANCA)

Anti-Saccharomyces Cerevisi?Antibodies (ASCA)

Liver Disorders

Autoimmunity may effect many varied systems in the body. A number of hepatic diseases are autoimmune in nature, including Autoimmune Hepatitis and Pernicious Anemia. Prompt and accurate diagnosis of these conditions is essential. Laboratory diagnostics are available to support diagnosis.

Autoimmune Hepatitis

Anti-Nuclear Antibodies (ANA)

Smooth Muscle Antibodies

LKM-1 Antibodies

Primary Billiary Cirrhosis

Mitochondrial Antibodies

M2 Antibodies

Pernicious Anemia/Autoimmune Gastritis

Gastric Parietal Cell Antibodies

Vesiculo-Bullous Disorders

The detection of anti-skin antibodies aids in the diagnosis and prognosis of chronic vesiculo-bullous diseases, including pemphigus, pemphigoid, mucous membrane (cicatricial) pemphigoid, and epidermolysis bullosa acquisita (EBA). Epithelial intercellular antibodies are diagnostic for pemphigus and antibodies to basement membrane antigens of stratified squamous epithelium occur in bullous pemphigoid, EBA and mucous membrane (cicatricial) pemphigoid. Serological differentiation of bullous pemphigoid from EBA can be aided by utilizing Split Skin tests.

Pemphigus

Paraneoplastic pemphigus

Bullous pemphigoid on split skin

Products Available

Code	Product Description	Determinations	Product Insert
			non-CE	CE
Immunofluorescence Kits
1104	IC/BMZ Skin Monkey/ Guinea Pig Esophagus 6x8 well kit	48
1105	IC/BMZ Skin Monkey Esophagus 8x6 well kit	48
1147	Monkey Esophagus/ Split Skin	48	N/A	N/A
Components
2147	Monkey Split Skin for BP/EBA differentiation Slide	6 well	N/A	N/A
2154	ASA IC/BMZ M-Guinea Pig Esophagus 6 well slide	6 well	N/A	N/A
2155	ASA IC/BMZ M-Esophagus 8 well slide	6 well	N/A	N/A
2156	Rat Bladder paraneoplastic pemphigus 6 well slide	6 well	N/A	N/A
2200	Negative Control	0.5 ml	N/A	N/A
2213	IC (Monkey and Guinea Pig Esophagus) Positive Control	0.5 ml	N/A	N/A
2214	Pemphigus Vulgaris Positive Control	0.5 ml	N/A	N/A
2216	Pemphigus Foliaceus Positive Control	0.5 ml	N/A	N/A
2217	Basement Membrane Zone (BMZ) Positive Control	0.5 ml	N/A	N/A
2241	Paraneoplastic Pemphigus Positive Control	0.5 ml	N/A	N/A
2276	Split Skin Positive Control	0.5 ml	N/A	N/A
2100	IgG Conjugate	5.0 ml	N/A	N/A

Immunological Findings in Vesiculo-Bullous Disorders

Endocrine Disorders

Autoimmunity may effect many varied systems in the body. A number of endocrine diseases are autoimmune in nature, including Addison's Disease and Thyroiditis. Prompt and accurate diagnosis of these conditions is essential. Laboratory diagnostics are available to support diagnosis.

Diabetes

Islet Cell Antibodies (ICA)

Addison's Disease

Adrenal Antibodies

Throiditis

Thyroid Antibodies

Thyrogloblin (Tg) Antibodies

Thyroid Peroxidase (TPO) Antibodies

Infertility

Steroidal Cell Antibodies

Neuropathies

Myelin Associated Glycoproteins (MAG) Antibodies Neuropathies associated with anti-MAG are often slowly progressive with evidence of demyelination and a variable degree of axonal loss associated with gait ataxia. 50% of all peripheral neuropathy cases with IgM paraproteinemia possess anti-MAG antibodies. Detection of anti-MAG autoantibodies is useful for the clinician, as it suggests active demyelination in a peripheral neuropathy. Immunofluorescence is a sensitive method for the screening and detection of anti-nerve myelin associated proteins and ganglioside autoantibodies. Specimens found positive by immunofluorescence can be confirmed using the Western Blot method.

Paraneoplastic Syndromes

Neuronal Antibodies The following auto-antibodies are found in paraneoplastic syndromes: anti-Hu, type I anti-neuronal nuclear antibody (ANNA-1), is associated with small cell lung cancer resulting in paraneoplastic encephalomyelitis (PE). anti-Yo, anti-purkinje cell antibodies (PCA-1), is associated with ovarian and breast carcinomas resulting in paraneoplastic cerebellar degeneration (PCD). anti-Ri, type II anti-neuronal nuclear antibody (ANNA-2), is associated with neuroblastoma (children) and fallopian or breast cancer (adults) resulting in paraneoplasticopsoclonus myoclonus ataxia (POMA). These markers help in discriminating between true paraneoplastic disorders and other inflammatory disorders of the nervous system that mimic a paraneoplastic syndrome. IFA provides a sensitive method of detecting these auto-antibodies. anti-Hu/anti-Ri autoantibodies, which characteristically stain the granular cell nucleus, are easily distinguished from the Purkinjee cell cytoplasm staining anti-Yo antibodies. Specimens found positive by IFA can be confirmed using the Western Blot method.

Products Available

Code	Product Description	Determinations	Product Insert
			non-CE	CE
Immunofluorescence Kits
1172	Myelin Associated Glycoproteins (MAG) 8x6 well kit	48
1111	Neuronal Antibody 8x6 well slide	48		N/A
Western Blot Kits
1173	Myelin Associated Glycoproteins (MAG)	20		N/A
1174	Neuronal antibody	20		N/A

Ganglioside Antibodies Patients exhibiting neuropathies elicit antibodies to gangliosides, acidic glycosphingolipids localized in the outer layer of plasma membranes. These antibodies may be directed against GM1, Asialo GM1, GD1a, GD1b, GQ1b, sulfatides and/or galactocerebroside.

Products Available

Code	Product Description	Determinations	Product Insert
			non-CE	CE
ELISA Kits
1180M	GM1 IgM ELISA	96
1180G	GM1 IgG ELISA	96
1181M	Asialo GM1 IgM ELISA	96
1181G	Asialo GM1 IgG ELISA	96
1183M	GD1b IgM ELISA	96
1183G	GD1b IgG ELISA	96
1184M	GQ1b IgM ELISA	96
1184G	GQ1b IgG ELISA	96
1185M	Galactocerebroside IgM ELISA	96
1185G	Galactocerebroside IgG ELISA	96
1186M	GD1a IgM	96
1186G	GD1a IgG	96

Neuropsychiatric Lupus

Ribosomal P & Ribonucleic Acid (RNA) Antibodies In patients with psychotic SLE, a group of autoantibodies is targeted against the ribosomal phosphoproteins, called P0 (38kD), P1 (19kD) and P2 (17kD). Preceding the onset of psychotic episodes in patients, a selective elevation of anti-Ribosomal P antibodies has been observed.	Ribosomal P on HEp-2

Products Available

Code	Product Description	Determinations	Product Insert
			non-CE	CE
ELISA Kits
1133	Ribosomal P Antibody	96		N/A
1166	Ribonucleic Acid (RNA) Ab	96	N/A

Incidence of anti-Ribosomal P Antibodies

anti-Ribosomal P Antibodies	% Positive
SLE
Lupus Psychosis	50
Non-psychotic CNS Lupus	34
SLE without CNS manifestations	8
Rheumatoid Arthritis	0
Scleroderma	< 1
Normal subject	0

Oxidized Low Density Lipoprotein Antibodies (oxLAb)

Antibodies to oxidized LDL (oxLAb) are present in sera of patients with a variety of conditions, such as essential hypertension, diabetes, coronary heart disease, carotid artherosclerosis and chronic renal failure. The detection of oxLAb has been proposed as an indirect mar ker of in vivo LDL oxidation and hence predictive of artherosclerosis. The ImmuLisa?oxLAb immunoassay takes into consideration the nonspecific binding of immunoglobulins to LDL and the antibody levels are expressed as the difference between absorbance values obtained on oxLDL vs. native LDL.

Products Available

Code	Product Description	Determinations	Product Insert
			non-CE	CE
ELISA Kits
1158	Oxidized Low Density Lipoprotein (oxLAb) kit	96		N/A

Heart Antibodies

Heart antibodies as detected by IFA have been described in 40% of patients with biopsyproven myocarditis and in 20% of patients with dilated cardiomyopathy. No antibodies have been detected in healthy controls. Only 4% of patients with ischemic heart disease are positive for heart antibodies. These autoantibodies generally produce three types of staining reactions: sarcolemmal, diffuse cytoplasmic and striational, producing the so-called fibrillar pattern.

anti-Heart Muscle

Products Available

Code	Product Description	Determinations	Product Insert
			non-CE	CE
Immunofluorescence Kits
1101H	Heart Antibodies 8x6 well kit	48
Components
2157	M-Heart Muscle 6 well slide	6 well	N/A	N/A
2171	Rat Heart 6 well slide	6 well	N/A	N/A
2235	Heart/Skeletal Muscle Antibody Positive Control	0.5 ml	N/A	N/A

Hearing Loss

Certain cases of hearing loss have been associated with autoimmunity. Such cases may involve an immune response targeting the inner ear alone or the hearing loss may be one symptom of systemic autoimmune disorders such as Cogan's syndrome, Wegener’s granulomatosis, polyarteritis nodosa, and systemic lupus erythomatosis. Cases in which hearing loss is the only symptom are termed primary autoimmune inner ear disease (AIED). When hearing loss occurs in the context of systemic autoimmunity this is known as secondary AIED. Because of the difficulty of diagnosing patients primary AIED, certain diagnostic markers have been identified to support diagnosis. These include the 68kD (hsp-70) antibodies and P0 antibodies. If treated promptly, patients with detectable levels of these antibodies have been shown to respond to immunosuppressive treatments with cessation of hearing loss or recovery of hearing.

Products Available

Code	Product Description	Determinations	Product Insert
*1190	OTOblot™ 68kD (hsp-70) Antibody Western Blot Assay	20
*1192	P0 Antibody Western Blot Assay	20	N/A