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CAH StripAssay

Short description

The CAH StripAssay® is CE-IVDR certified diagnostic tool designed for the rapid and precise identification of the most common point mutations associated with Congenital Adrenal Hyperplasia (CAH). Developed by ViennaLab, this assay is specifically targeted at the CYP21A2 gene, which is instrumental in the synthesis of crucial adrenal hormones. Utilizing a multi-step process involving DNA isolation, PCR amplification, and hybridization, the CAH StripAssay® provides clinicians with a cost-effective and reliable method for diagnosing CAH. It serves as an indispensable second-tier test, reducing false positives from traditional 17-OHP based screenings, and thereby facilitating more accurate and timely clinical interventions.

Product highlights

  • Highly Specific
  • Cost-Efficient
  • Fast Turnaround
  • CE-IVDR certified
  • User-Friendly
  • Clinical Relevance

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CAH 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 CAH StripAssay

CAH StripAssay® Diagnosing Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia (CAH) remains one of the most complex metabolic disorders inherited at birth, affecting the synthesis of vital adrenal steroid hormones like cortisol and aldosterone. The symptoms can range from virilization in female newborns to life-threatening salt-wasting conditions, which makes early and accurate diagnosis vital. Traditionally, CAH diagnosis involved neonatal screening based on the assessment of 17-hydroxyprogesterone (17-OHP) levels, a method riddled with high false positives.

A Multi-Step Diagnostic Procedure

The CAH StripAssay® follows a detailed, multi-step diagnostic procedure beginning with DNA isolation. After this, polymerase chain reaction (PCR) amplification takes place using biotinylated primers. The next step is a hybridization process, which occurs on a test strip containing allele-specific oligonucleotide probes immobilized as parallel lines. The assay ultimately identifies bound biotinylated sequences using streptavidin-alkaline phosphatase and color substrates.

Cost and Time Efficiency

One of the primary reasons to use CAH StripAssay®  is its cost and time efficiency compared to whole gene sequencing. While sequencing the entire gene provides an exhaustive list of possible mutations, it is often overkill for a disease like CAH, where the most common mutations are already well-documented. In that sense, the CAH StripAssay® delivers targeted results without incurring the unnecessary cost and time of a more extensive test.

A Clinical Imperative

Given the importance of early and accurate diagnosis—particularly for the severe salt-wasting form of the disease—current newborn screening programs are crucial as they may identify potential cases. However, the possibility of false positives typically requires a secondary, confirmatory test. The CAH StripAssay® serves as a useful second-tier test that can help reduce the number of false positives, aiding clinicians in making more informed decisions.

In summary, the CAH StripAssay® CE-IVDR serves as an additional diagnostic tool for CAH and metabolic disorders. It targets point mutations in the CYP21A2 gene, which enhances the specificity of diagnoses and complements existing screening protocols. It offers a cost-effective alternative with a faster turnaround time compared to other diagnostic methods, making it a viable option for diagnosing CAH. The CAH StripAssay® supports the goal of achieving more precise diagnoses and effective treatments for Congenital Adrenal Hyperplasia, which improves patient outcomes.

Components of the CAH StripAssay
  1. Lysis Solution (50 ml)
  2. GENXTRACT™ Resin (5 ml)
  3. Amplification Mix A (500 µl, yellow cap)
  4. Amplification Mix B (500 µl, white cap)
  5. Amplification Mix C (500 µl, green cap)
  6. Taq Dilution Buffer (500 µl, transparent cap)
  7. HS-Taq DNA Polymerase (175 U, red cap)
  8. DNAT (1.5 ml, blue cap)
  9. Typing Trays (3)
  10. Test Strips (20)
  11. Hybridization Buffer (25 ml, white cap)
  12. Wash Solution A (80 ml, white cap)
  13. Conjugate Solution (25 ml)
  14. Wash Solution B (80 ml)
  15. Color Developer (25 ml)
  16. Collector™ Sheet


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