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Cystic Fibrosis StripAssay

Short description

The Viennalab CF StripAssay® is a diagnostic tool that detects common mutations in the CFTR gene associated with cystic fibrosis. It is designed for use in clinical laboratories, offering specificity and sensitivity for identifying multiple genetic mutations. This test can process various sample types, including whole blood and buccal swabs, and provides results in approximately two hours.

Furthermore, the Viennalab CF StripAssay® is CE-IVDR certified, ensuring it meets regulatory standards for health and safety within the European Economic Area. It supports accurate diagnostics and carrier testing, making it a practical option for clinical settings.

Product highlights

  • Fast and reliable test for detecting common mutations
  • Easy-to-use and minimal hands-on time
  • Highly specific and sensitive
  • Suitable for a wide range of sample types
  • Ideal for clinical laboratories
  • CE-IVDR certified

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Cystic Fibrosis StripAssay

Specifications of the Cystic Fibrosis StripAssay

Cystic fibrosis (CF) is a genetic disorder that primarily impacts the lungs, pancreas, and other organs, stemming from mutations in the CFTR gene. This gene plays a crucial role in regulating the transport of salt and fluids across cell membranes. Diagnosing CF typically involves assessing clinical symptoms, conducting imaging studies, and performing laboratory tests.

A key tool in this diagnostic process is the Viennalab CF StripAssay®, which efficiently detects the most prevalent mutations in the CFTR gene. This test utilizes the reverse hybridization principle, employing allele-specific probes that identify mutations within genomic DNA samples. It is not only rapid, providing results in about two hours, but also reliable, thanks to its straightforward protocol that requires minimal hands-on time and standard laboratory equipment.

The simplicity of the Viennalab CF StripAssay® extends to its flexibility with various sample types such as whole blood, serum, plasma, and buccal swabs. Its high specificity and sensitivity are crucial, capable of detecting mutations at a minimum concentration of 5 ng/μL. It identifies key mutations like ΔF508, G542X, R553X, N1303K, and 1717-1G>A, which represent a significant proportion of CF cases globally.

The StripAssays are available in four different configurations to meet diverse genetic testing needs. The first configuration is designed for the German population (GER) and detects 31 common CFTR mutations. The second configuration targets the Turkish population (TUR), identifying 24 common CFTR mutations along with IVS8 variants 5T/7T/9T. The third is a standard option (STD) that detects 34 common CFTR mutations and includes the IVS8 variants 5T/7T/9T. Lastly, the extensive configuration (EXT) covers the 38 most common CFTR mutations and includes the IVS8 polyT variants found in the Caucasian population. These configurations ensure precise genetic analysis tailored to specific population genetics.

Moreover, the Viennalab CF StripAssay® is CE-IVDR certified, ensuring it meets high standards for health, safety, and environmental protection within the European Economic Area. The ability to test multiple mutations in a single assay makes the Viennalab CF StripAssay® a comprehensive option for both diagnosing CF and conducting carrier tests. Its clinical validation further attests to its accuracy and reliability.

In summary, the Viennalab CF StripAssay® offers a fast, accurate, and user-friendly approach to diagnosing cystic fibrosis. With its high sensitivity and specificity, coupled with the capability to detect multiple key mutations simultaneously, it stands out as an ideal choice for clinical laboratories aiming to improve CF diagnosis and carrier testing.

Components of the Cystic Fibrosis StripAssay
  1. Test strips
  2. Hybridization buffer
  3. Positive and negative control DNA
  4. DNA extraction buffer (if applicable)
  5. PCR amplification reagents (if applicable)
  6. User manual

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