5066 – DotDiver ANAcyto 10

Highlights

  • Qualitative dot immunoassay for IgG antibodies against nuclear and cytoplasmic antigens
  • Supports diagnosis of autoimmune myositis diseases
  • Detects Jo-1, PL-7, PL-12, EJ, OJ, KS, ZO, HA, SRP and P0 antibodies
  • Enables simultaneous multi-antigen testing on one strip
  • Semi-automated processing with the DotDiver instrument
  • Ready-to-use breakable test strips with integrated positive and negative controls
  • High-purity antigens for reliable and specific antibody detection
  • Enzyme-based color development for clear visual interpretation
  • Designed for professional in vitro diagnostic use
  • CE marked

Intended Use

The DotDiver ANAcyto 10 is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Jo-1, PL-7, PL-12, EJ, OJ, KS, ZO, HA, SRP and P0) in human serum. The DotDiver ANAcyto 10 is intended as an aid in the diagnosis of autoimmune myositis diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.


Diagnostic Relevance

Polymyositis, an idiopathic inflammatory muscle disorder with unclear causes, causes muscle weakness, atrophy of peripheral muscles, biochemical and electromyographic signs of muscle damage, and skin alterations. Many myositis patients develop autoantibodies to t-RNA synthetases. Specific autoantigens in polymyositis include histidyl (Jo-1), threonyl (PL-7), alanyl (PL-12), glycyl (EJ), isoleucyl (OJ), asparaginyl (KS), tyrosyl (HA), and phenylalanyl (ZO) synthetases.

Product Specifications

Title DotDiver ANAcyto 10
Product code 5066
Indication Autoimmune myositis diseases
Description Dot immunoassay for the qualitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum
Format Test strips coated with Jo-1, PL-7, PL-12, EJ, OJ, KS, ZO, HA, SRP and P0
Total incubation time 64 min.
Sample volume 10 µL serum
No. of determinations 24 x 10

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.