INTRODUCTION

Strip-Immunoassay with antigens produced by recombinant techniques for the de­tec­tion of IgG autoantibodies in rheumatic autoimmune diseases (Connective Tissue Diseases, CTD)

Autoantibodies are immunglobulines which are directed against endogenous structures.  In the case of CTD, the connective tissue is affected, which leads to inflammation, loss of elasticity and joint pain. According to their clinical symptoms, these diseases are assigned to the rheumatic disorders.

The following diseases belong to the connective tissue diseases:

• Systemic lupus erythematosus (SLE)
• Sjögren’s syndrome (SjS)
• Mixed connective tissue disease (MCTD)
• Progressive systemic scleroderma (PSS)
• Myositis

Autoantibodies are important diagnostic parameters with unclear pathogenetic significance, but of extraordinary relevance for differential diagnosis. The recomLine ANA/ENA IgG serves for the differentiation between rheumatic autoimmune diseases and other rheumatic diseases with similar symptoms.

PRODUCT ADVANTAGES

• Recombinant antigens
  • High sensitivity and specificity
  • Easy and clear interpretation due to easy to read bands
• Easy test procedure; automation possible
• Easy and objective strip interpretation and documentation with recomScan software
• Test procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable
• Safe evaluation due to strip specific cut-off control
• Determination of different autoantibodies in a single approach
• CE label: The recomLine ANA/ENA IgG test meets the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices
• All connective tissue diseases can be determined and usually be typified

TESTPRINCIPLE AND PROCEDURE

1^st Incubation
A test strip loaded with autoimmune antigens is incubated with diluted serum or plasma in a dish for 1 hour.

wash 3 times

2^nd Incubation
Peroxidase conjugated anti-human antibodies (IgG specific) are added. Incubate for 45 minutes.

wash 3 times

Color reaction
4-5 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.

RECOMBINANT ANTIGENS

EVALUATION

Specificity and prevalence

* These sera are not defined as ANA/ENA negative sera. The positive sera displayed distinct autoantibody band paterns, indicating a connective tissue disease. The sera with equivocal results showed only one faint antibody reaction against a single antigen.

Sensitivity

Sensitivities determined on the basis of defined positive sera (defined by clinical picture and/or specific antigen pattern).

STORAGE AND SHELF LIVE

At 2-8 °C 12 months from the date of production

COMMERCIAL PRODUCT