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FMF StripAssay

Short description

The FMF StripAssay® is a cutting-edge diagnostic tool designed for the accurate identification of Familial Mediterranean Fever (FMF) and associated risk factors for Amyloidosis. Utilizing reverse-hybridization technology, this assay pinpoints mutations in the MEFV gene, providing invaluable insights into the most common inherited inflammatory disorder. The easy-to-use test strips feature parallel arrays of allele-specific oligonucleotides, offering rapid and reliable results visible to the naked eye. Streamlined into a three-step process of amplification, hybridization, and identification, the FMF StripAssay® is an essential asset for healthcare providers seeking precision in FMF diagnosis and treatment planning.

Product highlights

  • Rapid Diagnosis
  • Genetic Accuracy
  • User-Friendly
  • Visual Results
  • Amyloid Risk
  • Comprehensive Coverage

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FMF StripAssay



Instructions for Use

Brochure StripAssays


For any missing information or if you require additional details, please do not hesitate to contact us. 

Specifications of the FMF StripAssay

Diagnosing Familial Mediterranean Fever and Assessing Amyloidosis Risk with the FMF StripAssay


Familial Mediterranean Fever (FMF) remains the most prevalent inherited inflammatory disorder, predominantly impacting populations of Mediterranean descent. Characterized by periodic episodes of fever and acute inflammation, the disorder can escalate into severe complications, notably systemic reactive (AA) amyloidosis, which potentially leads to organ failure. One of the groundbreaking advancements in the diagnosis and risk assessment of FMF and associated amyloidosis is the FMF StripAssay®.

Clinical Significance of FMF

FMF originates from mutations in the MEFV gene, responsible for the synthesis of a protein known as pyrin or marenostrin. These mutations exert a variable influence on the clinical manifestations of FMF, as well as on the risk for developing AA amyloidosis. The medical community currently relies on colchicine as a prophylactic treatment, reducing the occurrence of amyloidosis and enabling patients to maintain a normal life quality.

The Amyloidosis Factor

Amyloidosis results from the extracellular deposition of serum amyloid A (SAA) fragments, culminating in irreversible organ damage. It is of note that the homozygous condition of the SAA isotype SAA1.1 is associated with an elevated risk of developing AA amyloidosis in FMF patients.

A Closer Look at FMF StripAssay®

The FMF StripAssay® leverages reverse-hybridization of biotinylated PCR products and utilizes allele-specific oligonucleotides immobilized on a test strip. The detection of bound biotinylated sequences is accomplished using streptavidin-alkaline phosphatase and color substrates, with the outcomes easily discernible to the naked eye.

Analytical Procedure

The FMF StripAssay® follows a tripartite analytical framework:

  1. Amplification: This entails Multiplex PCR that simultaneously labels biotin.
  2. Hybridization: Conducted directly on the StripAssay® test strips.
  3. Identification: The biotin-labelled sequences are detected through a streptavidin-alkaline phosphatase reaction, either by visual inspection or specialized scanner and software.

Utility in Medical Practice

The assay is intended for the clinical identification of mutations in the MEFV gene, based on a highly reliable methodology that encompasses DNA isolation, PCR amplification, and reverse-hybridization. It has the capability to cover 12 mutations in the MEFV gene, thereby offering an exhaustive view of FMF and its associated risk factors.

Concluding Remarks

The FMF StripAssay® has emerged as a game-changer in the diagnostic landscape of FMF and associated amyloidosis risk. The technology’s precision, coupled with its streamlined procedure, places it at the forefront of personalized medicine. This innovation is poised to significantly augment the diagnostic accuracy, paving the path for timely therapeutic interventions and enhancing patient outcomes.

Components of the FMF StripAssay
  • Lysis Solution: 50 ml
  • GENXTRACT™ Resin: 5 ml
  • Amplification Mix: 500 µl (Yellow Cap)
  • Taq Dilution Buffer: 500 µl (Transparent Cap)
  • DNAT: 1.5 ml (Blue Cap, Warning)
  • Typing Trays: 3 included
  • Test Strips: 20 included
  • Hybridization Buffer: 25 ml (White Cap)
  • Wash Solution A: 80 ml (White Cap)
  • Conjugate Solution: 25 ml
  • Wash Solution B: 80 ml
  • Color Developer: 25 ml (Warning)
  • Collector™ Sheet: 1 included

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