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ANA-AMA-SMA-PCA Double Sec.

Technology : IFA ~ Autoimmune IFA Screen

Brand : MarDx® ~ Autoimmune IFA Screen

Analyte : Autoimmune ~ Systemic Rheumatoid Diseases

Intended Use

The detection, differentiation and quantitation of circulating autoimmune antibodies in human serum utilizing indirect immunofluorescence (IFA).

Principle

ANA antibodies are not organ or species specific.(6) The primary test reaction involves circulating antinuclear antibodies present in the patients serum which attach to their homologous nuclear antigens. This occurs during the incubation period while the serum covers the antigen surface. A secondary reaction then follows a rinsing period which removes all unbound human antibody. The reagent used in the secondary reaction is a fluorescein labeled anti-human globulin conjugate. The antigen surface is then thoroughly rinsed free of unbound onjugate and viewed under an appropriate fluorescent microscope for various morphological patterns of nuclear fluorescence which can be visually identified. (10) The clinical significance of the various nuclear immunofluorescent patterns is useful in evaluating patients for the presence of the connective tissue diseases. The homogeneous pattern is the most common pattern and is associated with SLE. The peripheral pattern confirms a clinical diagnosis of SLE. True speckled nuclear fluorescence is seen in Scleroderma, Raynaud's disease, Rheumatoid Arthritis, and Sjogren's syndrome. Nucleolar fluorescence is seen mainly in Scleroderma and Sjogren's syndrome.

Product Code : 10-2396

Format : Mardx 8 wells

Test/Kit : 96 tests

FDA : Cleared

CE : Cleared

Additional Information :
Click here to view. (PDF 239.82KB)

Insert Version : MDN 04-0028eng rev 6

Package Inserts
AUTOIMMUNE ANTIBODY IFA SCREENING TEST SYSTEM (English)
Click here to view. (PDF 56.27KB)
SISTEMA DE PRUEBA IFA PARA LA DETECCIÓN DE ANTICUERPOS AUTOINMUNES (Spanish)
Click here to view. (PDF 61.87KB)
IFA-SCREENING-TESTSYSTEM FÜR AUTOIMMUN-ANTIKÖRPER (German)
Click here to view. (PDF 65.78KB)