4220 – BiermAK LINE

Highlights

• Use of purified porcine intrinsic factor and H⁺/K⁺ ATPase (alpha and beta subunits) as solid-phase antigens
• Supports the diagnosis of systemic vasculitis and autoimmune renal disorders
• Helps differentiate Goodpasture syndrome from other causes of glomerulonephritis and pulmonary hemorrhage
• High diagnostic relevance for cANCA (PR3) and pANCA (MPO) autoantibodies
• Ready-to-use test strips and reagents for reproducible results
• Rapid, reliable, and professional in vitro diagnostic use
• Ready-to-use reagents (except wash buffer) for convenience
• Suitable for routine laboratory testing
• CE marked

Intended Use

The BiermAK LINE is a qualitative line immunoassay for the determination of IgG antibodies against intrinsic factor and parietal cell antigens in human serum. The BiermAK LINE is intended as an aid in the diagnosis of chronic atrophic gastritis in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Chronic atrophic gastritis of type A is an autoimmune condition that leads to the destruction of parietal cells and the production of autoantibodies targeting both parietal cells and intrinsic factor, a glycoprotein essential for vitamin B12 absorption. The main antigen of parietal cell autoantibodies is the membrane-bound H⁺/K⁺ ATPase, which plays a critical role in acid secretion in the stomach. Antibodies to this ATPase serve as a sensitive marker for type A gastritis, appearing in approximately 80–90% of affected patients.

Autoantibodies to intrinsic factor are primarily observed in patients with pernicious anemia associated with gastritis. These antibodies are considered pathognomonic for this condition. These autoantibodies can interfere with the binding and transport of vitamin B12, leading to deficiency and subsequent clinical manifestations. Detection of these antibodies not only supports the diagnosis of chronic atrophic gastritis but also provides essential information for early therapeutic intervention, monitoring disease progression, and identifying patients at risk of developing vitamin B12 deficiency or related complications, including increased risk of gastric carcinoma.